Join the team that’s bringing IMMUNO-INGENUITY to life

Let’s reshape the future of treating and preventing cancer & infectious disease.

Today, Inovio is poised to be the leader in the research and development of new and exciting therapies in oncology and infectious diseases. We aspire to develop and deliver breakthrough treatment modalities in disease states where effective cures have remained elusive. That’s because immuno-ingenuity is part of our DNA, and a dynamic entrepreneurial spirit is at the core of who we are.

The technology is here, and our team is growing. Now is the time for revolutionizing the world of immunotherapies. Now is the time to join the Inovio team—where passionate people are making a difference with immuno-ingenuity and more.

Career opportunities

Inovio Pharmaceuticals, Inc. is currently welcoming qualified applications for the following career opportunities:

  • Position

    Location

  • Clinical Associate, Device

    Clinical Operations

    San Diego, CA

    Company Profile

    Inovio is a late-stage biotechnology company focused on the discovery, development, and commercialization of DNA immunotherapies that transform the treatment of cancer and infectious diseases. Inovio is taking immunotherapy to the next level in the fight against cancer and infectious diseases. Inovio has reported generating T cells in vivo in high quantity that are fully functional and whose killing capacity correlates with relevant clinical outcomes with a favorable safety profile. With an expanding portfolio of immune therapies, the company is advancing a growing preclinical and clinical stage product pipeline. Partners and collaborators include MedImmune, Regeneron, Roche/Genentech, ApolloBio Corporation, The Wistar Institute, University of Pennsylvania, the Parker Institute for Cancer Immunotherapy, CEPI, DARPA, GeneOne Life Science, Plumbline Life Sciences, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, and Laval University. For more information, visit www.inovio.com.

    Job summary

    Clinical Associate, Device is responsible for evaluating all clinical processes to determine needs for creation of new processes and/or revision of existing processes related to enterprise device operations in clinical trials. This includes being an effective liaison within Clinical Operations, and between Regulatory, Engineering, Manufacturing, QA, R & D departments and consultants, as needed; collaboration with Device Training Specialists and Clinical Project Leads to establish processes for clinical device disposition and compliant accountability; training clinical, CRO staff and OUS consultants on INOVIO device processes, and facilitating device complaint reporting and data review process improvements. The Clinical Associate, Device will complement study oversight of Inovio, investigator and partner sponsored research to ensure compliance with protocol(s), federal regulations, ICH, GCP, ISO and local requirements which ensure safety and data integrity. Duties may include assistance with external consultants, and oversight of clinical trial operations as performed by a CRO or consultants. 

    Essential job functions and duties

    • Evaluate overall existing clinical processes to determine needs for revision of existing or creation of new device-centric processes or procedures in conjunction with Clinical Operations and key interdependent Inovio Stakeholders.
    • Collaborate with Device Training Specialists, Device Clinical Operations, QA and MFG to establish processes for clinical device ordering, returns, tracking, and accountability.
    • Work with clinical teams to understand device supply requirements for ongoing and upcoming clinical studies.
    • Assist with clinical review and reconciliation of device data and the development/implementation of device data management software platforms.
    • Assist with preparation of all forms of device training materials, plans and implementations
    • Work with Manufacturing Operations to ensure inventory and efficient device distribution systems.
    • Assist with device labeling process improvements and streamlining efforts
    • Assist with device complaint process, such as, investigation, resolution tracking and reporting improvements
    • Prepare SOPs, work instructions, and reports as well as other documents.
    • Ensure compliance with regulatory guidelines in the development of documentation
    • Provide progress updates and summaries to management.
    • Develop tools and processes that increase project efficiencies.
    • Assist with regulatory documents for FDA and other regulatory submissions, as needed.
    • Serve as a Clinical resource by consulting with Clinical Project Leads and Device Training Specialists to augment the device training curriculum and to train clinical study site personnel on device processes (e.g., Device Accountability Logs). 
    • Oversee and communicate device-related information between Clinical, Regulatory, Engineering, Manufacturing, Quality Assurance, R&D and Product Development either independently or at interdepartmental meeting settings.
    • Participates on device project management teams and provides clinical device updates and summaries to management.
    • Support management with implementation of departmental strategies and policies.
    • As time allows, participates in product development activities for next generation devices. 
    • Travel: Up to 20%, primarily domestic.

    Minimum requirements

    • Bachelor’s degree in a relevant scientific discipline required
    • At least 3+ years of medical device clinical research experience; device instruments a plus
    • Knowledge of Medical Device FDA/GCP/ICH/ISO regulations
    • Area(s) of expertise desired: Medical Device Instrumentation, Biology, Immunology, Bioengineering, Cell or Molecular Biology.

    Disclaimer

    Inovio Pharmaceuticals, Inc. is committed to a policy of equal employment opportunity. In keeping with our policy, Inovio will recruit, hire, train and promote into all job titles the most qualified individuals, without regard to race, color, creed, gender, religion, marital status, registered domestic partner status, age, national origin or ancestry, veteran status, physical or mental disability, medical condition including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws.

    A current US work authorization is required. The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Inovio offers an attractive benefits package and is an equal opportunity employer. 

    Apply
  • Manufacturing Engineer I

    Device Manufacturing Operations

    San Diego, CA

    Company Profile

    Inovio is a late-stage biotechnology company focused on the discovery, development, and commercialization of DNA immunotherapies that transform the treatment of cancer and infectious diseases. Inovio is taking immunotherapy to the next level in the fight against cancer and infectious diseases. Inovio has reported generating T cells in vivo in high quantity that are fully functional and whose killing capacity correlates with relevant clinical outcomes with a favorable safety profile. With an expanding portfolio of immune therapies, the company is advancing a growing preclinical and clinical stage product pipeline. Partners and collaborators include MedImmune, Regeneron, Roche/Genentech, ApolloBio Corporation, The Wistar Institute, University of Pennsylvania, the Parker Institute for Cancer Immunotherapy, CEPI, DARPA, GeneOne Life Science, Plumbline Life Sciences, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, and Laval University. For more information, visit www.inovio.com

    Job summary

    The Manufacturing Engineer I is an entry level position for an engineer to assist in developing and improving manufacturing processes, techniques and procedures associated with the building and maintaining of medical devices (electromechanical and sterile disposable) used in ongoing clinical trials. The tasks are completed with a steady focus on continuous improvement of product quality through leaner concepts and activities.

    Essential job functions and duties

    • Create drawings and models in Solidworks with assistance and guidance from senior manufacturing engineers.
    • Design, implement (verify/validate), document and troubleshoot manufacturing tooling and testing fixtures with minimal to moderate supervision.
    • With guidance, implement new and revised documentation through Change Control System.
    • Working with senior manufacturing engineers, help develop/modify new processes and procedures for new and existing product lines which may include modification to floor layout changes.
    • Support manufacturing, process validation, development, and product research efforts with guidance.
    • With instruction and oversight, create and revise Manufacturing and Testing Work Instructions including visual aids, Specifications, Inspection and Qualification Documentation.
    • Perform equipment qualification/validation.
    • Investigate and report manufacturing issues, failures and non-conformances.  Support Quality System Technical Compliance with participation in Material Review Board, Non-Conforming Material Investigations and Corrective and Preventative Action (CAPA) activities.
    • Assist in solving production related problems and clearly and concisely document solutions.
    • Follow processes and procedures for supporting and developing products.
    • Complete other engineering duties as assigned.

    Minimum requirements

    • BSME or BSEE degree
    • Minimum 0-1 year engineering experience in medical industry
    • Highly experienced user of Microsoft Office Suite to create documentation, spreadsheets, and databases to support Manufacturing operations
    • Capable of researching moderate to complicated engineering concepts and understanding and presenting these concepts in a clear concise manner to peers and management.
    • Solidworks or other 3D Modeling experience
    • Excellent written and oral communication skills
    • Excellent attention to detail
    • Proven professional qualities including strong initiative, integrity, and the desire / ability to work in a team environment
    • Possess good mechanical and electrical aptitude
    • Ability to organize and manage multiple projects simultaneously
    • Promote a positive, professional atmosphere and support activities that enhance the welfare and morale of Inovio employees

    Disclaimer

    Inovio Pharmaceuticals, Inc. is committed to a policy of equal employment opportunity. In keeping with our policy, Inovio will recruit, hire, train and promote into all job titles the most qualified individuals, without regard to race, color, creed, gender, religion, marital status, registered domestic partner status, age, national origin or ancestry, veteran status, physical or mental disability, medical condition including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws.

    A current US work authorization is required.  The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Inovio offers an attractive benefits package and is an equal opportunity employer. 

    Apply
  • Quality Control Technician (3 Month Temporary/Contractor)

    Quality

    San Diego, CA

    Company Profile

    Inovio is a late-stage biotechnology company focused on the discovery, development, and commercialization of DNA immunotherapies that transform the treatment of cancer and infectious diseases. Inovio is taking immunotherapy to the next level in the fight against cancer and infectious diseases. Inovio has reported generating T cells in vivo in high quantity that are fully functional and whose killing capacity correlates with relevant clinical outcomes with a favorable safety profile. With an expanding portfolio of immune therapies, the company is advancing a growing preclinical and clinical stage product pipeline. Partners and collaborators include MedImmune, Regeneron, Roche/Genentech, ApolloBio Corporation, The Wistar Institute, University of Pennsylvania, the Parker Institute for Cancer Immunotherapy, CEPI, DARPA, GeneOne Life Science, Plumbline Life Sciences, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, and Laval University. For more information, visit www.inovio.com.

    Job summary

    The Quality Control (QC) Technician performs a wide variety of duties including, but not limited to, receiving & inspecting raw materials, Supply Chain Quality activities, supporting the Returned Goods Authorization (RGA) process, performing Device History Record (DHR) reviews, and supporting Quality System compliance to all applicable standards and regulations. The QC Technician is knowledgeable in the application and performance of mechanical and visual evaluations utilizing all facility inspection and test equipment and will be assigned various auditing, investigation and testing tasks to meet departmental and facility goals. The position is responsible for all processing of NCMRs through the QC area including initiating NCMRs, assigning NCMR numbers, evaluating/reviewing need for MRB review, closure/review of completed NCMRs, and data entry into the NCMR database. The position maintains the calibration database, ensures that all equipment is calibrated on time and resolve any repair issues with calibrated equipment.

    Essential job functions and duties

    • Perform Receiving and Inspection functions for incoming raw materials and finished purchased goods.
    • Support the Returned Goods Authorization (RGA) process as needed to maintain continuous flow and increase inventory accuracy.
    • Perform visual and mechanical inspection of product and components per procedure, specification or drawings using measuring equipment (i.e. caliper, micrometer, tape, height gauge, etc.)
    • Perform work-in-process and inventory transactions to ensure systems and physical product movement.
    • Assist in the resolution of Non-Conforming materials and product related issues.
    • Perform documentation reviews of Device History records, inspection and test results.
    • Support activities of the Corrective Action Board (CAB) as necessary.
    • Ensure that all calibrated equipment is calibrated or removed from service prior to the due date.
    • Maintain the Calibration database, perform all data entry.
    • Inspect Work in Progress (WIP) and finished goods items.
    • Provide administrative / technical support to the Functional Area Leader of Device Quality in the performance of investigations on reported product failures, adverse events or field complaints in accordance with FDA, MDD, CMDR, and ISO 9000 requirements.
    • Update and create Standard Operating Procedures for Quality System related activities.
    • Perform other related tasks as assigned.

    Minimum requirements

    • Associate's degree (AA) or equivalent from two year college or an equivalent combination of education and experience.
    • 3-5 years of Quality Control experience in the medical device or pharmaceutical / biotech industry, with working knowledge of FDA and ISO regulations.
    • ASQ CQT certification a plus.
    • Strong organizational, project management and communication skills and the ability to perform varied tasks in a disciplined, consistent manner.
    • Must be able to work under minimum supervision and in a team environment.
    • Ability to read, analyze, and interpret technical procedures and regulations.
    • Ability to work with mathematical problems such as adding, subtracting, multiplying, dividing, decimals and math conversions.  Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
    • Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
    • Ability to lift heavy items (35 lbs.).

    Disclaimer

    Inovio Pharmaceuticals, Inc. is committed to a policy of equal employment opportunity. In keeping with our policy, Inovio will recruit, hire, train and promote into all job titles the most qualified individuals, without regard to race, color, creed, gender, religion, marital status, registered domestic partner status, age, national origin or ancestry, veteran status, physical or mental disability, medical condition including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws.

    A current US work authorization is required.  The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Inovio offers an attractive benefits package and is an equal opportunity employer. 

    Apply
  • Quality Engineer

    Quality Assurance

    San Diego, CA

    Company Profile

    Inovio is a late-stage biotechnology company focused on the discovery, development, and commercialization of DNA immunotherapies that transform the treatment of cancer and infectious diseases. Inovio is taking immunotherapy to the next level in the fight against cancer and infectious diseases. Inovio has reported generating T cells in vivo in high quantity that are fully functional and whose killing capacity correlates with relevant clinical outcomes with a favorable safety profile. With an expanding portfolio of immune therapies, the company is advancing a growing preclinical and clinical stage product pipeline. Partners and collaborators include MedImmune, Regeneron, Roche/Genentech, ApolloBio Corporation, The Wistar Institute, University of Pennsylvania, the Parker Institute for Cancer Immunotherapy, CEPI, DARPA, GeneOne Life Science, Plumbline Life Sciences, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, and Laval University. For more information, visit www.inovio.com.

    Job summary

    The Quality Assurance Engineer is responsible for providing Quality Assurance input and guidance for Manufacturing, Supply Chain Quality, and R&D activities. The QA Engineer will also be responsible for supporting quality assurance and regulatory issues to assure compliance with FDA regulations, corporate directives, ISO 13485 standards and Company strategies.

    Essential job functions and duties

    • Actively participate in defining activities to assure compliance to all Internal Policies and Procedures as well as to all External Standards (QSR, CMDR, ISO 13485 and the MDD).
    • Take a leadership role in the development of quality and operating procedures to assure alignment with current GMP/QSR, ISO and MDD requirements.
    • Participate in New Product Development and be responsible for the development of quality plans, verification of engineering tests and measurement practices for new and existing products using QA Tools (TQM, FME, DOE, SPC, and Risk analysis).
    • Analyze problems occurring in the processing, fabricating, assembling and testing of products and develop changes and corrections to prevent reoccurrence.
    • Develop inspection and testing methods and participate in the preparation of quality assurance specifications and procedures to implement such methods.
    • Take a leadership role in assuring all activities in the area of equipment, process and software validations meet FDA and International regulatory requirements.
    • Actively participate in the review of engineering specifications to assure that adequate quality assurance requirements are met and designs are adequately transferred into manufacturing with high process capability measured against Critical to Quality Design Output Requirements.
    • Administer supplier audits, surveys and initiation of corrective action plans.
    • Serve as Chairperson of  the Material Review Board (MRB)
    • Support annual training to the requirements of QSR, CMDR, ISO 13485 and the MDD for all appropriate personnel as necessary.
    • Participate in CAPA meetings to ensure adherence to requirements and closure of CAPAs
    • Oversee and manage incoming Supplier Quality. Initiate and drive Supplier Corrective Actions.
    • Facilitate Design and Process FMEA’s and oversee mitigation efforts to closure.
    • Participate in design reviews to ensure adherence to design control requirements -- review drawings for adherence to design inputs; material callouts and standards and procedures; and regulatory and QS requirements; verify that required reports are attached so that the project can proceed to the next phase.

    Minimum requirements

    • Bachelor’s Degree preferred.  Engineering degree or experience in a related field and/or a combination of practical and educational experience in the medical device industry is required.
    • 3-5 years of experience in engineering and quality with the application and implementation of (GMP/QSR/ISO/MDD and Canadian Medical Device) regulations a plus, with focus on Design control/transfer, process validations, product development supports required.
    • ASQ CQE desired after attainment of position, if not already held.
    • Lean Six Sigma Green Belt or higher is also preferred. Experience with alternative Quality related tools (D and P, FMEA, QFD, SPC, Risk Analysis, DOE, and TQM) also a plus.
    • Proficiency in Microsoft Word, Excel and Outlook, Visio, Power Point Visual Basic, Access, and Mini-Tab or other comparable statistical analysis software application.
    • Ability to write reports, business correspondence, and procedure manuals.
    • Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
    • Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
    • Competent working knowledge of US, Canadian and International safety standards for medical devices.
    • Proven project management skills; able to complete technical projects with minimal supervision.
    • Ability to understand and interpret electrical and mechanical drawings and data - electronic schematic diagrams, wiring diagrams, mechanical part drawings, assembly drawings, block and flow diagrams, and BOMs.
    • Strong organizational, project management and communication skills and the ability to perform varied tasks in a disciplined, consistent manner.
    • Ability to work in a team environment.

    INOVIO DOES NOT PROVIDE VISA SPONSORSHIP

    Disclaimer

    Inovio Pharmaceuticals, Inc. is committed to a policy of equal employment opportunity. In keeping with our policy, Inovio will recruit, hire, train and promote into all job titles the most qualified individuals, without regard to race, color, creed, gender, religion, marital status, registered domestic partner status, age, national origin or ancestry, veteran status, physical or mental disability, medical condition including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws.

    A current US work authorization is required.  The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Inovio offers an attractive benefits package and is an equal opportunity employer. 

    Apply
  • Scientist, Analytical Sciences

    Research and Development

    San Diego, CA

    Company Profile

    Inovio is a late-stage biotechnology company focused on the discovery, development, and commercialization of DNA immunotherapies that transform the treatment of cancer and infectious diseases. Inovio is taking immunotherapy to the next level in the fight against cancer and infectious diseases. Inovio has reported generating T cells in vivo in high quantity that are fully functional and whose killing capacity correlates with relevant clinical outcomes with a favorable safety profile. With an expanding portfolio of immune therapies, the company is advancing a growing preclinical and clinical stage product pipeline. Partners and collaborators include MedImmune, Regeneron, Roche/Genentech, ApolloBio Corporation, The Wistar Institute, University of Pennsylvania, the Parker Institute for Cancer Immunotherapy, CEPI, DARPA, GeneOne Life Science, Plumbline Life Sciences, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, and Laval University. For more information, visit www.inovio.com.

    Job summary

    The Scientist has a background in Immunology and supports the increasing clinical developments in the Analytical Sciences group within the R&D department. The position encompasses the development, qualification, validation and execution of immunological assays related to the clinical assessment of DNA-based vaccines, and human immune monitoring.

    Essential job functions and duties

    • Perform statistical analysis of data, write SOPs and reports.
    • Design and develop immunology assays.
    • Troubleshoot immunology assays.
    • Provide training, guidance, and assistance to new and existing Research Associates.
    • Generate standard operating procedures, qualification and validation reports and technical reports.
    • Support overall laboratory efforts in maintaining compliance.
    • Oversee data management.

    Minimum requirements

    • PhD degree in a Biological Science
    • 3-5 years hands-on research experience in cellular immunology assays
    • Proficiency in flow cytometry acquisition and analysis (FlowJo) software .
    • Familiarity with a broad range of immunology assays.
    • Strong experience in humoral and cellular immunological assays with human samples.
    • Ability to independently prioritize multiple projects with great efficiency in order to boost productivity.
    • Collaborates and communicates effectively with colleagues and management in order to enhance the technical capabilities of the laboratory.

    Disclaimer

    Inovio Pharmaceuticals, Inc. is committed to a policy of equal employment opportunity. In keeping with our policy, Inovio will recruit, hire, train and promote into all job titles the most qualified individuals, without regard to race, color, creed, gender, religion, marital status, registered domestic partner status, age, national origin or ancestry, veteran status, physical or mental disability, medical condition including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws.

    A current US work authorization is required.  The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Inovio offers an attractive benefits package and is an equal opportunity employer. 

    Apply
  • Software Engineer - .Net, C#

    Engineering Development

    San Diego, CA

    Company Profile

    Inovio is a late-stage biotechnology company focused on the discovery, development, and commercialization of DNA immunotherapies that transform the treatment of cancer and infectious diseases. Inovio is taking immunotherapy to the next level in the fight against cancer and infectious diseases. Inovio has reported generating T cells in vivo in high quantity that are fully functional and whose killing capacity correlates with relevant clinical outcomes with a favorable safety profile. With an expanding portfolio of immune therapies, the company is advancing a growing preclinical and clinical stage product pipeline. Partners and collaborators include MedImmune, Regeneron, Roche/Genentech, ApolloBio Corporation, The Wistar Institute, University of Pennsylvania, the Parker Institute for Cancer Immunotherapy, CEPI, DARPA, GeneOne Life Science, Plumbline Life Sciences, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, and Laval University. For more information, visit www.inovio.com.

    Job summary

    In this role, the software engineer develops and enhances PC-based applications for interface with Electroporation Devices. The SW engineer creates applications and tools to support automated manufacturing testing. The position also creates requirements and design documents, participates in technical reviews and supports investigation of field issues, documents the software design and verification activities, and utilizes version control and issue management systems. 

    Essential job functions and duties

    • Develop and enhance PCand Web based Applications
    • Design and implement database applications
    • Design and develop manufacturing test automation tools
    • Perform unit, integration and system level testing
    • Develop .Net based serial port application to communicate with embedded device.
    • Define and document software requirements and software design
    • Participate in design and code reviews
    • Develop PC based simulators on Visual Studio
    • Interface with firmware and quality engineers.
    • Provide support for failure investigation
    • Develop new processes and procedures for improve the overall software quality
    • Complete other engineering duties as assigned.

    Minimum requirements

    • Minimum B.S. degree in Engineering or Computer Science
    • 5+ years of experience in design and development  applications using .Net framework
    • Good knowledge of WinForms, WPF, SQL database, MVC Framework and Web service
    • Strong GUI development skills for embedded devices.
    • Experience asynchronous and multi-threaded programming
    • Experience in creating and execution software verification protocols
    • Strong experience in RDBMS, including SQL Server
    • Excellent problem-solving, design, development, and debugging skills.
    • Experience in ISO13485 regulated Quality system
    • Visual Studio, Configuration Management
    • Experience with safety certified software development
    • Familiarity setting up various embedded toolchains, build and debugging environments.
    • Experience with software Engineering processes and tools
    • Experience in interfacing PC based application with serial port is a plus
    • Experience working with cloud (Azure, AWS) service is a plus.
    • Good communication skills.
    • C++ experience is a plus

    Disclaimer

    Inovio Pharmaceuticals, Inc. is committed to a policy of equal employment opportunity. In keeping with our policy, Inovio will recruit, hire, train and promote into all job titles the most qualified individuals, without regard to race, color, creed, gender, religion, marital status, registered domestic partner status, age, national origin or ancestry, veteran status, physical or mental disability, medical condition including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws.

    A current US work authorization is required.  The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Inovio offers an attractive benefits package and is an equal opportunity employer. 

    Apply
  • Software Engineer - .Net, C#

    Engineering Development

    San Diego, CA

    Company Profile

    Inovio is a late-stage biotechnology company focused on the discovery, development, and commercialization of DNA immunotherapies that transform the treatment of cancer and infectious diseases. Inovio is taking immunotherapy to the next level in the fight against cancer and infectious diseases. With an expanding portfolio of immune therapies, the company is advancing a growing preclinical and clinical stage product pipeline. Partners and collaborators include MedImmune, Regeneron, Roche/Genentech, ApolloBio Corporation, The Wistar Institute, University of Pennsylvania, the Parker Institute for Cancer Immunotherapy, CEPI, DARPA, GeneOne Life Science, Plumbline Life Sciences, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, and Laval University. For more information, visit www.inovio.com.

    Job summary

    In this role, the software engineer develops and enhances PC-based applications for interface with Electroporation Devices. The SW engineer creates applications and tools to support automated manufacturing testing. The position also creates requirements and design documents, participates in technical reviews and supports investigation of field issues, documents the software design and verification activities, and utilizes version control and issue management systems. 

    Essential job functions and duties

    • Develop and enhance PCand Web based Applications
    • Design and implement database applications
    • Design and develop manufacturing test automation tools
    • Perform unit, integration and system level testing
    • Develop .Net based serial port application to communicate with embedded device.
    • Define and document software requirements and software design
    • Participate in design and code reviews
    • Develop PC based simulators on Visual Studio
    • Interface with firmware and quality engineers.
    • Provide support for failure investigation
    • Develop new processes and procedures for improve the overall software quality

    Minimum requirements

    • Minimum B.S. degree in Engineering or Computer Science
    • 5+ years of experience in design and development  applications using .Net framework
    • Good knowledge of WinForms, WPF, SQL database, MVC Framework and Web service
    • Strong GUI development skills for embedded devices.
    • Experience asynchronous and multi-threaded programming
    • Experience in creating and execution software verification protocols
    • Strong experience in RDBMS, including SQL Server
    • Excellent problem-solving, design, development, and debugging skills.
    • Experience in ISO13485 regulated Quality system
    • Visual Studio, Configuration Management
    • Experience with safety certified software development
    • Familiarity setting up various embedded toolchains, build and debugging environments.
    • Experience with software Engineering processes and tools
    • Experience in interfacing PC based application with serial port is a plus
    • Experience working with cloud (Azure, AWS) service is a plus.
    • Good communication skills.
    • C++ experience is a plus

    Disclaimer

    Inovio Pharmaceuticals, Inc. is committed to a policy of equal employment opportunity. In keeping with our policy, Inovio will recruit, hire, train and promote into all job titles the most qualified individuals, without regard to race, color, creed, gender, religion, marital status, registered domestic partner status, age, national origin or ancestry, veteran status, physical or mental disability, medical condition including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws.

    A current US work authorization is required.  The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Inovio offers an attractive benefits package and is an equal opportunity employer. 

    Apply
  • Staff Accountant - Accounts Payable/Payroll

    Accounting & Finance

    San Diego, CA

    Company Profile

    Inovio is a late-stage biotechnology company focused on the discovery, development, and commercialization of DNA immunotherapies that transform the treatment of cancer and infectious diseases. Inovio is taking immunotherapy to the next level in the fight against cancer and infectious diseases. Inovio has reported generating T cells in vivo in high quantity that are fully functional and whose killing capacity correlates with relevant clinical outcomes with a favorable safety profile. With an expanding portfolio of immune therapies, the company is advancing a growing preclinical and clinical stage product pipeline. Partners and collaborators include MedImmune, Regeneron, Roche/Genentech, ApolloBio Corporation, The Wistar Institute, University of Pennsylvania, the Parker Institute for Cancer Immunotherapy, CEPI, DARPA, GeneOne Life Science, Plumbline Life Sciences, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, and Laval University. For more information, visit www.inovio.com.

    Job summary

    The Staff Accountant performs day-to-day full-cycle accounts payable duties and provides backup support for the bi-weekly payroll process. The position interacts with vendors to resolve issues and questions and interfaces with employees across the company, The Staff Accountant provides other support to the accounting team as may be required during month-end close and for other critical deadlines.

    Essential job functions and duties

    • Audit vendor invoices and match invoices to purchase orders, packing slips, and other applicable supporting documents.
    • Process and reconcile company credit card statements.
    • Accurate and timely entry of invoices and PO receipts into accounting system to ensure that invoices are paid on time.
    • Compliance with SOX internal controls applicable to job functions.
    • Assist and support internal and external SOX audits.
    • Audit and verify expense reports for accuracy and appropriate approval.
    • Reconcile vendor statements, research and resolve discrepancies.
    • Perform check runs and process wire payments.
    • Distribute signed checks as required.
    • Respond to vendor inquiries and actively pursue timely resolution of issues with vendors, such as past-due invoices.
    • Provide backup support for bi-weekly payroll; review and ensure accuracy of approved Time & Attendance data in compliance with established company standards and policy; correct any errors including incorrect time recording; complete batch adjustments to payroll.
    • Develop an in-depth understanding of the payroll system and database in order to troubleshoot issues as well as design and run reports as needed.
    • Lead A/P system conversion and other process automation projects as assigned.
    • Assist the G/L accounting team in the month-end close process and expense/invoice research, as needed.
    • Assist/Perform ad hoc duties as needed.

    Minimum requirements

    • Associates Degree or higher in accounting or business; Bachelor’s Degree preferred
    • Minimum of 3 years’ experience in full-cycle A/P with some general accounting.
    • Working experience with ERP systems to assist system implementation and related testing.
    • Knowledge in A/P process automation.
    • Proficiency in Microsoft Applications, intermediate to advanced knowledge of Excel preferred.
    • Ability to learn new systems and applications.
    • High degree of accuracy and attention to detail.
    • Ability to pay attention to processes or steps leading to the accomplishment of results, looking for ways to improve quality, efficiency, and effectiveness.
    • Ability to meet assigned deadlines.
    • Effective time management skills and ability to prioritize.
    • Excellent communication and interpersonal skills.
    • Ability to act and operate independently with minimal daily direction from manager to accomplish objectives.
    • Flexibility for potential new tasks.
    • Professional demeanor and ability to collaborate in a team environment with all internal and external stakeholders.

    Disclaimer

    Inovio Pharmaceuticals, Inc. is committed to a policy of equal employment opportunity. In keeping with our policy, Inovio will recruit, hire, train and promote into all job titles the most qualified individuals, without regard to race, color, creed, gender, religion, marital status, registered domestic partner status, age, national origin or ancestry, veteran status, physical or mental disability, medical condition including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws.

    A current US work authorization is required.  The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Inovio offers an attractive benefits package and is an equal opportunity employer. 

    Apply
  • Are you an MD considering a move into industry?

    Clinical Development

    Plymouth Meeting, PA

    Company Profile

    Inovio is taking immunotherapy to the next level in the fight against cancer and infectious diseases. The company is advancing a growing clinical and preclinical stage product pipeline. Partners and collaborators include MedImmune, Roche, University of Pennsylvania, DARPA, GeneOne Life Science, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, and University of Manitoba. For more information, visit www.inovio.com.

    Job summary

    Inovio is hiring an MD to work Clinical Development at our Plymouth Meeting office.   The MD provides strategic contribution and support for Inovio Pharmaceuticals while collaborating with respective Commercial, Biostatistics, Epidemiology, and Clinical colleagues in the development and implementation of components of an External Engagement, Data Generation and Lifecycle program for multiple assets.

    This person would work under the VP of Clinical Development to support these areas of responsibility:

    Accountable for safety across the study:

    • Provide study team with medical advice for all medical issues during risk assessment and mitigation planning to enable quality, compliance and patient safety at the trial, site and patient level.

    • Ensures development of and adherence to safety review.  Performs and documents regular review of individual subject safety data, and performs review of cumulative safety data. 

    • Monitor study safety issues and provide input to serious adverse events (SAEs) reports.

    • Participates in Safety Review to evaluate medical benefits/risks to support targeted clinical indications.

    • Reviews literature as needed to respond to safety questions.

    • Communicates safety information to sites across the study and provides responses to questions on safety.

     

    Protocol design and strategy:

    • Provide medical input during development and updates to the clinical development plan.

    • Designs clinical studies to meet the stated objectives.  Assures that clinical trial objectives fit with the clinical program strategy.

    • Ensure that documents (protocol, Informed Consent Document [ICD], etc) meet regulatory requirements and company policy and has been reviewed by IRB/IECs.

    • Provides medical input into country feasibility.

    Support study team

    • Provides clinical input to protocol/study team for monitoring guidelines, statistics analysis plans, ICDs, clinical review forms, data edit checks, data quality planning, as needed.

    • Develop and maintain peer to peer relationships with healthcare professionals at clinical trial sites.

    • Contributes to contract research organization / vendor selection to ensure study is conducted consistent with protocol requirements, clinical plan expectations, and study timelines; this includes ensuring medical/technical requirements for data integrity are applied.

    • Works with study team to ensure high quality of data, e.g. appropriate patient population, adequacy of clinical assessments etc., as study is ongoing.

    • Conducts medical review and interpretation of efficacy and safety data from clinical trials; this includes delivery of top-line report in collaboration with study statistician, and delivery of clinical study report in collaboration with medical writer; accountable for overall quality and timeliness of analysis and reporting.

    • Responsible for medical and scientific validity of study report, especially conclusions regarding efficacy and safety.  Responsible for disclosure of appropriate safety and efficacy data and conclusions (e.g. ClinicalTrials.gov, EudraCT.).

    • Provides protocol specific training to study team, investigators, clinical research associate, and others.

    • Interact with healthcare professionals at sites during the conduct of the study to enable quality, compliance and patient safety at the trial, site and patient level.

    • Interacts with Data Monitoring Committees and Steering Committees as required.

    • Coordinates medical opinions with other physicians globally to ensure consistency.

    • Notify appropriate study team personnel of the need to inform investigators of any changes in research activity and any significant new adverse events.

    • Monitor investigator compliance with protocol and regulatory requirements.

    • Support study team in issues resolution, study closeout, audit responses, inspection readiness, etc.

    Supports the program team:

    • Authors clinical sections of regulatory documents (e.g. Investigator Brochure, Annual Reports, Investigational New Drug sections, Clinical Study Reports).

    • May co-author abstracts, posters, presentations and publications.

    • Acts as clinical representative in in-licensing activities such as due diligence reviews and reports.

    • As a key member of the Program team, interfaces with discovery, safety sciences, statistics, clinical pharmacology, commercial, regulatory, outcomes research, Development Operations and other members of the extended project team(s).

    • Responsible for the on-time and within-budget execution of protocols.

     Interact with regulatory authorities, key opinion leaders, and principal investigators:

    • Support Regulatory Authority interactions accountable for providing responses.

    • Liaise with Key Opinion Leaders and Principal Investigators in countries to build a Key Opinion Leaders /Principal Investigators network for new trials.

    The preferred candidate has the following education and experience:

    MD with pharmaceutical experience, or similar drug development experience in an academic setting.   Our preferred candidate will have experience in these areas:

    • Immuno-Oncology or Infectious Disease
    • Pharmacovigilance
    • Clinical Development
    • Working with KOLs and advisory boards
    • Challenging the status quo and asking probing questions
    • Timely project execution
    Apply
  • Clincal Scientist

    Clinical

    Plymouth Meeting, PA

    Company Profile

    Inovio is revolutionizing the fight against cancer and infectious diseases. Our immunotherapies uniquely activate best-in-class immune responses to prevent and treat disease, and have shown clinically significant efficacy with a favorable safety profile. With an expanding portfolio of cancer immunotherapies and clinical studies, the company is advancing a growing product pipeline. Partners and collaborators include Roche, the University of Pennsylvania, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, US Dept. of Homeland Security, and University of Manitoba. For more information, visit www.inovio.com. 

    Job summary

    The Associate Clinical Scientist (ACS) will be responsible for supporting, under the guidance of the Clinical Scientist (CS), all aspects of Clinical Trial  Planning, Management and Execution of studies being conducted under an IND as well a as investigator sponsored research and program level activities as assigned within Clinical Operations at Inovio. The ACS will ensure accurate and complete data collection and compliance with protocol(s) and Federal regulations, ICH-GCPs, and local requirements. Duties may also include assisting with the oversight of clinical trial operations as performed by a CRO or other external consultants.

    Summary of essential job functions

    Support the multidisciplinary Clinical Trial Team (CTT) to ensure trial deliverables are met according to timelines, budget, quality standards and operational best practices. Undertakes defined responsibilities delegated by the CS, including regional management of study conduct, and/or vendor oversight of study related tasks. 

    Maintain knowledge of ICH-GCPs, external regulations and procedures, and supplement by training and practice of Inovio SOPs and internal policies. Thorough understanding of regulatory requirements regarding the Trial Master File (TMF). Support the set up and maintenance of the TMF for studies, ensuring all relevant study documents are filed and archived at the end of the study according to the appropriate guidelines.

    • Assist in training for Clinical Trial Associate (CTA) (s). Assist CTA(s) with understanding and execution of assigned duties.
    • Assist in the preparation of pre-audit activities for nominated projects ensuring a satisfactory outcome is achieved.
    • Preparation of informational documentation and communications for designated projects, including internal and external communication.
    • Coordinates and supports the CS with consultant and vendor meetings. Works with the CTA(s) to ensure meeting requirements and plan has been appropriately arranged ahead of meeting(s).
    • Assists in the development and management of clinical protocols and amendments, informed consent forms, investigators brochure (IB), training material, case report forms, diary cards, clinical study reports and other clinical documents. Ensures compliance with regulatory guidelines in the development of documentation.
    • Assists in overseeing and tracking recruitment and retention of study subjects.
    • Assists with management of study timelines, study progress, and mitigating challenges that develop
    • Provides progress updates and summaries to the CS and/or management
    • Develop tools and processes that increase efficiencies of the project
    • Is able to communicate study-related information to investigators and study staff as delegated by the CS
    • Regularly update all trial information databases in order to manage accuracy of information, including internal Clinical Trial Management systems (CTMS) and external databases according to Inovio disclosure policies and individual country regulations
    • Assists in preparation of regulatory documents for FDA and other regulatory submissions
    • Supports the CS and management with implementation of departmental strategies and policies
    • Works with Clinical Data Management on assigned projects
    • Assists the CS in vendor and site oversight
    • Assists the CS in the management and tracking of clinical supplies, including drug, devices, lab kits, etc.
    • Assist the CS in planning and conduct of Investigator Meetings
    • Receive on-the-job training for any tasks not previously conducted
    • Travel: Up to 20%, primarily domestic


     

    Minimum requirements

    • Bachelor/Master’s degree
    • At least 3 years of clinical research experience; Regulatory Affairs experience a plus
    • Area(s) of expertise desired: Biology, Immunology, Bioengineering, Cell or Molecular Biology Experience with vaccines highly preferred
    • Excellent oral and written communication skills, attention to detail and ability to interact effectively with cross-functional teams and management
    • Ability to prioritize diverse projects for multiple disciplines
    • Knowledge of all applicable regulations, including FDA, ICH and ISO guidelines; medical device experience a plus
    • Understanding of clinical trials process and protocol objectives
    • Knowledge and ability to implement Good Clinical Practices
    • MS Office Suite experience, Outlook and clinical trial software experience, IT computer literacy
    • Demonstrated organizational skills

    Disclaimer

    The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Inovio offers an attractive benefits package and is an equal opportunity employer.

    Apply
  • Clinical Data Manager

    Clinical Development

    Plymouth Meeting, PA

    Company Profile

    Inovio is revolutionizing the fight against cancer and infectious diseases. Our immunotherapies uniquely activate best-in-class immune responses to prevent and treat disease, and have shown clinically significant efficacy with a favorable safety profile. With an expanding portfolio of cancer immunotherapies and clinical studies, the company is advancing a growing product pipeline. Partners and collaborators include Roche, the University of Pennsylvania, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, US Dept. of Homeland Security, and University of Manitoba. For more information, visit www.inovio.com. 

     Job Summary

    Data Manager will collaborate with biostatistics, programming, clinical development/operations, regulatory affairs and outside vendors. Experience with data management on vaccine, oncology, or infectious disease trials is a plus.

    • Essential job functions and duties
    • All aspects of data management  (DM) related to assigned projects include:
    • Assist in Vendor management/oversight
    • Assist in oversight of Database design
    • Assist in the review and creation of edit check specifications
    • Assist in CRF design/review
    • Review of clinical data for accuracy
    • Generation of adhoc reports/listings
    • Assist in creation/review of data management plans
    • Assist in coordinating activities with statistics and programming for DM deliverables 
    • Assist in User acceptance testing for CDMS and IXRS system as needed
    • Track quality issues and general data trends
    • Ensure adequate filing and archiving of relevant data and documentation related to DM
    • Assist in development of SOPs and work instructions
    • Work effectively as a team player

     Additional functions may include:

    • Assist EDC training for co-workers, site staff, and CRAs
    • Assist in facilitating interim safety reviews
    • Other duties as needed
    • Minimum requirements

    BA/BS degree

    • Minimum of 0-5 years of experience in clinical data management in the pharmaceutical/ biotechnology/ CRO setting
    • Self-starter, able to communicate well within a team environment; candidate will be proactive in managing and completing tasks in a timely fashion
    • Knowledge of Electronic Data Capture (EDC) and related tools and processes, preferred
    • Knowledge of database design and database concepts, preferred

     Essential Requirements:

    • Good verbal and written communication skills as well as interpersonal and organizational skills
    • Attention to detail, ability to prioritize and handle multiple tasks
    • Proficiency in MS Office applications
    • Travel up to 10-15%

    Disclaimer

    The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Inovio offers an attractive benefits package and is an equal opportunity employer.  

    Apply
  • Clinical Program Manager, AFRICA / MENA

    Clinical Operations

    Plymouth Meeting, PA

    Company Profile

    Inovio is a late-stage biotechnology company focused on the discovery, development, and commercialization of DNA immunotherapies that transform the treatment of cancer and infectious diseases. Inovio is taking immunotherapy to the next level in the fight against cancer and infectious diseases. Inovio has reported generating T cells in vivo in high quantity that are fully functional and whose killing capacity correlates with relevant clinical outcomes with a favorable safety profile. With an expanding portfolio of immune therapies, the company is advancing a growing preclinical and clinical stage product pipeline. Partners and collaborators include MedImmune, Regeneron, Roche/Genentech, ApolloBio Corporation, The Wistar Institute, University of Pennsylvania, the Parker Institute for Cancer Immunotherapy, CEPI, DARPA, GeneOne Life Science, Plumbline Life Sciences, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, and Laval University. For more information, visit www.inovio.com.

    Job summary

    Responsible for delivering clinical trials conducted in Africa and MENA region. S/he will play a critical role in ensuring that these trials are executed in a way that meets ICH, GCPs, and local requirements. S/he will help ensure these trials achieves maximum productivity, efficiency, and compliance to international and local standards, including processes associated with study start-up, conduct, and close-out. S/he will achieve these objectives through a) providing a day-to-day support to clinical project (in coordination with relevant field-based and/or central team project leaders), b) coordination and communication between Inovio and field-based (clinical site and local MOH) personnel), c) the development or refinement of context-appropriate study management tools and training resources to support the conduct of clinical trials, d) effective and collaborative management of Inovio’s program partners (e.g., CEPI, etc.), and e) provide capacity-building and technical guidance to Inovio’s central team personnel.  Duties may also include oversight of clinical trial operations as performed by a CRO or other external consultants.

    Essential job functions and duties

    • Prepare and finalize project and study-related documents including: informed consent forms, clinical trial outlines, monitoring plans, synopses, protocols and amendments, IND annual updates and clinical summaries, as required.
    • Select investigators and study sites.
    • Identify and respond to site and study related issues and recommend corrective actions and/or escalations.
    • Coordinate the design, format and content of CRFs, study guides, study reference binders, patient diaries, and forms including participating in the EDC and IXRS specification process and UAT.
    • Ensure that CRF data queries are resolved.
    • Coordinate and manage Investigational Product including overall accountability and reconciliation.
    • Prepare study budgets and timelines.
    • Manage project timelines and vendor performance to meet departmental and corporate goals.
    • Manage study budget and payment process for all clinical trial vendors including investigative sites.
    • Monitor and track clinical trial progress and provide status update reports.
    • Manage all clinical trial vendors.
    • Responsible for selection of CRO study staff and coordinating training including documentation.
    • Hire, train and oversee study field monitors (e.g., review of all trip reports) and provide guidance on site issues.
    • Lead the planning of investigator meetings and making presentations, as required.
    • Lead the review of clinical data at the CRF, data listing, and report table levels.
    • Represent Clinical Operations at the project team level for individual studies, as appropriate.
    • Partner with other research and development groups to achieve deliverables.
    • Participate in Site Initiation Visits (SIVs) as required.
    • Co-monitoring of regional sites for adherence to protocol and GCP as required.
    • Travel (Africa and Middle East) as required to carry out responsibilities.
    • Identify and escalate site, vendor and study related issues, as appropriate.
    • Participate in clinical and department settings, including attending additional meetings as required, interacting in a positive and professional manner.
    • Perform other duties as assigned.

    Minimum requirements

    • BA/BS in related field.
    • Experience in conducting trials in Africa and Middle East.
    • Minimum 8 years clinical drug development experience.
    • Work experience in NGO settings is preferred.
    • Experience in personnel management.
    • Experience in CRO selection and management, including drafting request for proposals (RFPs), bidding process, etc.
    • Experience in managing infectious disease clinical trials (emerging infectious diseases preferred).
    • Knowledge of FDA regulatory requirements and medical practice/techniques and terminology.
    • Knowledge and understanding of local (Africa and Middle East) regulatory and EC requirements for clinical trials. 
    • Ability to work within a team, including leadership skills.
    • Ability to organize and prioritize multiple tasks.
    • Excellent communication and interpersonal skills.
    • Attention to detail, organization, and problem-solving skills.
    • Proficient in MS Office.

    Disclaimer

    Inovio Pharmaceuticals, Inc. is committed to a policy of equal employment opportunity. In keeping with our policy, Inovio will recruit, hire, train and promote into all job titles the most qualified individuals, without regard to race, color, creed, gender, religion, marital status, registered domestic partner status, age, national origin or ancestry, veteran status, physical or mental disability, medical condition including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws.

    A current US work authorization is required. The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Inovio offers an attractive benefits package and is an equal opportunity employer. 

    Apply
  • Clinical Scientist (Trial Manager - Oncology)

    Clinical Development

    Plymouth Meeting, PA

    Company Profile

    Inovio is revolutionizing the fight against cancer and infectious diseases. Our immunotherapies uniquely activate best-in-class immune responses to prevent and treat disease, and have shown clinically significant efficacy with a favorable safety profile. With an expanding portfolio of cancer immunotherapies and clinical studies, the company is advancing a growing product pipeline. Partners and collaborators include Roche, the University of Pennsylvania, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, US Dept. of Homeland Security, and University of Manitoba. For more information, visit www.inovio.com. 

    Job summary

    Responsible for overall clinical study conduct of Inovio and investigator sponsored research, including verification of source documentation versus Case Report Forms to ensure accurate and complete data and compliance with protocol(s) and Federal regulations, ICH, & GCPs, and local requirements. Duties may also include oversight of clinical trial operations as performed by a CRO or other external consultants.

    Summary of essential job functions

    • Develops and manages clinical protocols and amendments, informed consent forms, training material, case report forms, diary cards, clinical study reports and other clinical documents, and contributes to the development of investigator's brochures. Ensures compliance with regulatory guidelines in the development of documentation.
    • Oversees study conduct and communicates study-related information to investigators and study staff. Oversees and tracks recruitment and retention of study subjects.
    • Manages study timelines. Reports on study progress and provides options for handling problems that develop. Provides progress updates and summaries to management. Develop tools and processes that increase efficiencies of the project.
    • Prepares regulatory documents for FDA and other regulatory submissions. Supports management with implementation of departmental strategies and policies.
    • Travel: Up to 20%, primarily domestic.

    Minimum requirements

    • Bachelor/Masters degree.
    • At least 3 years of clinical research experience. Regulatory affairs experience a plus.
    • Area(s) of expertise desired: Biology, Immunology, Bioengineering, Cell or Molecular Biology. Experience with vaccines highly preferred.

    Essential requirements

    • Excellent oral and written communication skills, attention to detail and ability to interact effectively with management and prioritize diverse projects for multiple disciplines.
    • Thorough knowledge of all applicable regulations, including FDA, ICH and ISO guidelines. Medical device experience a plus.

    Disclaimer

    The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Inovio offers an attractive benefits package and is an equal opportunity employer.

    Apply
  • Director CQA, Plymouth Meeting PA

    Quality Assurance

    Plymouth Meeting, PA

    Job summary

    The Director CQA will conduct and oversee global clinical GCP Site and Vendor audits, and GCP Internal Process audits. Facilitate ongoing quality improvements through communication of audit results and compliance guidance. Issue audit reports for response and provide acceptance/rejection of audit finding responses in addition to tracking/trending. 

    Essential job functions and duties

    • Ensures the quality and compliance of the Company’s development programs and clinical operations activities with respect to internal procedures as well as applicable regulations.
    • Drive the direction, development, implementation, and execution of a GCP Quality framework.
    • Position is responsible for selection and oversight of vendors/consultants/contractors hired to perform audits on Inovio’s behalf.
    • Act as independent QA per ICH E6 regarding audits, audit certificate, audit report etc. and Sponsor responsibilities for QA and QC. 
    • Contribute to Clinical QA problem solving. Identify compliance issues and propose solutions.
    • Provide QA Oversight of Clinical sample control for bioanalytical analysis done within or contracted by Inovio.
    • Assist with the integration and harmonization of Quality programs between the San Diego and the Plymouth Meeting facilities. Help direct, develop, manage and maintain the Inovio Global Quality System, with emphasis on Global GCP requirements.
    • Develop and enhance Clinical Quality Assurance SOPs and policies reports, including recommendations for improvements and training, and provide immediate alerts to critical issues or events as they arise or become apparent.
    • .Function as contact person for Sponsor Audits/Clinical Regulatory Inspections before, during and after their visits.
    • Develop and manage CQA departmental budget (travel, conferences, consultants, etc.).
    • Provide GCP/QA consultation and related training for Inovio staff. Keep up-to-date with relevant Regulatory Guidelines, and provide updates to staff as appropriate.. Promote quality standards and quality awareness for all Company staff.
    • Review, edit and approve, as needed, controlled documents (Policies, SOPs, Work Instruction/Guidelines). Write SOPs for clinical QA roles and responsibilities.

    Minimum requirements

    • Bachelor’s degree required in a related discipline with an advanced degree preferred
    • Minimum of 10 years’ experience in the performance, execution and oversight of independent Clinical QA audits in a global sponsor environment including experience with GCP focused vendors and internal processes and document auditing experience
    • Accreditation/certification related to audit and/ or clinical research through a professional organization/ certifying body (e.g. ASQ, SQA, ISO13485, etc.)
    • Extensive knowledge of US and International Pharmaceutical regulations, guidelines and directives from agencies such as FDA, EMA, MHRA etc. along with in-depth experience with ICH GCP Guidelines (e.g. E6, E3, E2A).
    • Experienced with Computer Systems Validation as it relates to clinical databases and software.

     Essential requirements

    • Ability to interact at all levels (internally and externally) while demonstrating diplomacy, professionalism and tact. Good business acumen with customer focus in interacting with peers, sites and clients
    • Attention to detail, thoroughness and analytical skills.
    • Excellent communication skills
    • Good organizational and time management skills;
    • Ability to travel globally a minimum of 30%       
    • Advanced computer skills, particularly with MS Word, Excel and the Internet
    Apply
  • Director of Clinical Development (MD), Oncology

    Clinical Development

    Plymouth Meeting, PA

    Company Profile

    Inovio is taking immunotherapy to the next level in the fight against cancer and infectious diseases. The company is advancing a growing clinical and preclinical stage product pipeline. Partners and collaborators include MedImmune, Roche, University of Pennsylvania, DARPA, GeneOne Life Science, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, and University of Manitoba. For more information, visit www.inovio.com.

    Job summary

    Inovio is hiring a Director, Clinical Development – Oncology to work in our Plymouth Meeting office.   The Director provides strategic contribution and support for Inovio Pharmaceuticals while collaborating with respective Commercial, Biostatistics, Epidemiology, and Clinical colleagues in the development and implementation of components of an External Engagement, Data Generation and Lifecycle program for multiple assets.

     

    These are the primary areas of responsibility:

     

    Accountable for safety across the study:

    • Provide study team with medical advice for all medical issues during risk assessment and mitigation planning to enable quality, compliance and patient safety at the trial, site and patient level.

    • Ensures development of and adherence to safety review.  Performs and documents regular review of individual subject safety data, and performs review of cumulative safety data. 

    • Monitor study safety issues and provide input to serious adverse events (SAEs) reports.

    • Participates in Safety Review to evaluate medical benefits/risks to support targeted clinical indications.

    • Reviews literature as needed to respond to safety questions.

    • Communicates safety information to sites across the study and provides responses to questions on safety.

     

    Protocol design and strategy:

    • Provide medical input during development and updates to the clinical development plan.

    • Designs clinical studies to meet the stated objectives.  Assures that clinical trial objectives fit with the clinical program strategy.

    • Ensure that documents (protocol, Informed Consent Document [ICD], etc) meet regulatory requirements and company policy and has been reviewed by IRB/IECs.

    • Provides medical input into country feasibility.

     

    Support study team

    • Provides clinical input to protocol/study team for monitoring guidelines, statistics analysis plans, ICDs, clinical review forms, data edit checks, data quality planning, as needed.

    • Develop and maintain peer to peer relationships with healthcare professionals at clinical trial sites.

    • Contributes to contract research organization / vendor selection to ensure study is conducted consistent with protocol requirements, clinical plan expectations, and study timelines; this includes ensuring medical/technical requirements for data integrity are applied.

    • Works with study team to ensure high quality of data, e.g. appropriate patient population, adequacy of clinical assessments etc., as study is ongoing.

    • Conducts medical review and interpretation of efficacy and safety data from clinical trials; this includes delivery of top-line report in collaboration with study statistician, and delivery of clinical study report in collaboration with medical writer; accountable for overall quality and timeliness of analysis and reporting.

    • Responsible for medical and scientific validity of study report, especially conclusions regarding efficacy and safety.  Responsible for disclosure of appropriate safety and efficacy data and conclusions (e.g. ClinicalTrials.gov, EudraCT.).

    • Provides protocol specific training to study team, investigators, clinical research associate, and others.

    • Interact with healthcare professionals at sites during the conduct of the study to enable quality, compliance and patient safety at the trial, site and patient level.

    • Interacts with Data Monitoring Committees and Steering Committees as required.

    • Coordinates medical opinions with other physicians globally to ensure consistency.

    • Notify appropriate study team personnel of the need to inform investigators of any changes in research activity and any significant new adverse events.

    • Monitor investigator compliance with protocol and regulatory requirements.

    • Support study team in issues resolution, study closeout, audit responses, inspection readiness, etc.

     

    Supports the program team:

    • Authors clinical sections of regulatory documents (e.g. Investigator Brochure, Annual Reports, Investigational New Drug sections, Clinical Study Reports).

    • May co-author abstracts, posters, presentations and publications.

    • Acts as clinical representative in in-licensing activities such as due diligence reviews and reports.

    • As a key member of the Program team, interfaces with discovery, safety sciences, statistics, clinical pharmacology, commercial, regulatory, outcomes research, Development Operations and other members of the extended project team(s).

    • Responsible for the on-time and within-budget execution of protocols.

     

    Interact with regulatory authorities, key opinion leaders, and principal investigators:

    • Support Regulatory Authority interactions accountable for providing responses.

    • Liaise with Key Opinion Leaders and Principal Investigators in countries to build a Key Opinion Leaders /Principal Investigators network for new trials.

     

    The preferred candidate has the following education and experience:

    MD with at least 3 years pharmaceutical experience, or similar drug development experience in an academic setting.   Our preferred candidate will have experience in these areas:

    • Immuno-Oncology
    • Pharmacovigilance
    • Clinical Development
    • Working with KOLs and advisory boards
    • Challenging the status quo and asking probing questions
    • Timely project execution
    Apply
  • Director/Senior Director, Regulatory Affairs, CMC

    Regulatory Affairs

    Plymouth Meeting, PA

    Company Profile

    Inovio is a late-stage biotechnology company focused on the discovery, development, and commercialization of DNA immunotherapies that transform the treatment of cancer and infectious diseases. Inovio is taking immunotherapy to the next level in the fight against cancer and infectious diseases. Inovio has reported generating T cells in vivo in high quantity that are fully functional and whose killing capacity correlates with relevant clinical outcomes with a favorable safety profile. With an expanding portfolio of immune therapies, the company is advancing a growing preclinical and clinical stage product pipeline. Partners and collaborators include MedImmune, Regeneron, Roche/Genentech, ApolloBio Corporation, The Wistar Institute, University of Pennsylvania, the Parker Institute for Cancer Immunotherapy, CEPI, DARPA, GeneOne Life Science, Plumbline Life Sciences, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, and Laval University. For more information, visit www.inovio.com.

    Job summary

    The Director/Senior Director, Regulatory Affairs, CMC is an integrated leadership role that has a broad spectrum of responsibilities spanning regulatory submissions, health authority interactions, compliance, internal advisory activities, and personnel management responsibilities. This person will ensure Inovio’s compliance with internal SOPs, local, regional, national, and international regulatory laws, standards, and regulations.

     

    Chemistry, Manufacturing, and Controls

    • Responsible for the review, approval, and release of the CMC section of a high-volume of development and maintenance regulatory submissions. Submissions are recognized as high quality as demonstrated by limited review rounds and minimal Health Authority questions.
    • Works closely with Manufacturing to resolve complex CMC issues by demonstrating in-depth understanding of regulations, drug/biologics design, manufacturing, and analytical methods.
    • Develops, recommends, and communicates strategic direction and best possible regulatory position to achieve desired outcomes. Effective review, approval, and release procedures assure that CMC submissions are of the highest quality while meeting current Health Authority regulatory expectations and business needs according to defined timelines.
    • Responsible for interactions/strategic negotiations with CMC representatives from Regulatory Agencies to assure that appropriate and pragmatic positions can be negotiated with the highest probability of success. 
    • Responsible for development of strategy and risk assessments for CMC activities.  Assures that, for major CMC activities that have a critical regulatory and/or financial impact, appropriate strategies are developed to manage the activities, and risks are identified, communicated, and mitigated as necessary.
    • Leads the review of internal policies and procedures and external regulatory guidance, trends, policies, and procedures. Effective internal and external participation on policies, regulations, and guidance is critical to maintaining the expertise and positive image of CMC Expert in an evolving regulatory environment.
    • Communication of complex and unusually complicated regulatory information and tactical issues to management
    • Develops excellent working relationships with internal regulatory and external functional partners; including, vendors, partners, and collaborators.

     

     Other Global Regulatory Affairs Responsibilities (commensurate with experience):

    • Sets strategy for global regulatory submissions to health authorities worldwide
    • Oversees organization and compilation of global regulatory submissions and other correspondence to US and international regulatory agencies that may be considered moderately complex in support of Inovio’s pharmaceutical/medical device combination product in Phase I-III programs
    • Maintains up-to-date knowledge of the data, information, and formats required for inclusion in these applications
    • Utilizes regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure governmental approvals are obtained
    • Health Authority Interactions:
    • Interacts with key personnel in regulatory agencies to ensure the review and approval of development plans, the timely resolution of issues, and the approval of applications
    • Effectively plans, organizes, and conducts formal meetings/teleconferences with regulatory agencies for designated programs

     

    Regulatory Compliance:

    • Provides interpretive analyses of complex regulatory guidance documents, regulations, proceedings, or directives that impact Inovio’s products and operations to Vice President, Regulatory Affairs and Executive Management team for assessment of potential impact on development programs
    • Internal Advisory Activities:
    • Develops global regulatory strategic plan and provides guidance to cross-functional project team
    • Reviews and approves data and documentation required for medical device/pharmaceutical combination product regulatory submissions
    • Provides input into development of regulatory and quality systems
    • Maintain awareness of international regulatory legislation and assess its impact on product development programs. Review applicable regulatory proceedings and maintain awareness of and report potential impact of regulations to senior management  
    • Lead, supervise, and provide technical guidance to high performing medical device regulatory team

     

    Minimum requirements

    • Ph.D., M.D, Pharm. D degree strongly preferred together with extensive experience in development of biologics. Candidates with a Master’s degree will be considered with relevant experience.
    • A minimum of 10 years in regulatory affairs with biopharmaceutical products with a minimum of 5 years in CMC development
    • Knowledge and/or experience in one or more of the following fields; oncology, infectious diseases, molecular biology or immunology
    • Excellent oral and written communication, interpersonal and organizational skills, and attention to detail
    • Ability to interact effectively with management and prioritize multiple projects 
    • Technical proficiency, effective problem solving and critical thinking skills
    • Ability to consistently meet tight timelines and deadlines
    • Ability to work in a team environment
    Apply
  • MD, Clinical Development, Infectious Diseases VETERANS WANTED

    Clinical Development

    Plymouth Meeting, PA

    Company Profile

    Inovio is taking immunotherapy to the next level in the fight against cancer and infectious diseases. The company is advancing a growing clinical and preclinical stage product pipeline. Partners and collaborators include MedImmune, Roche, University of Pennsylvania, DARPA, GeneOne Life Science, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, and University of Manitoba. For more information, visit www.inovio.com.

    Job summary

    Inovio is hiring an MD to work in our Plymouth Meeting office.   This position provides strategic contribution and support for Inovio Pharmaceuticals while collaborating with respective Commercial, Biostatistics, Epidemiology, and Clinical colleagues in the development and implementation of components of an External Engagement, Data Generation and Lifecycle program for multiple assets.  This position is a great entry point into Clinical Development in the Pharmaceutical Industry.

    These are the primary areas of responsibility:

    Accountable for safety across the study:

    • Provide study team with medical advice for all medical issues during risk assessment and mitigation planning to enable quality, compliance and patient safety at the trial, site and patient level.

    • Ensures development of and adherence to safety review.  Performs and documents regular review of individual subject safety data, and performs review of cumulative safety data. 

    • Monitor study safety issues and provide input to serious adverse events (SAEs) reports.

    • Participates in Safety Review to evaluate medical benefits/risks to support targeted clinical indications.

    • Reviews literature as needed to respond to safety questions.

    • Communicates safety information to sites across the study and provides responses to questions on safety.

     

    Protocol design and strategy:

    • Provide medical input during development and updates to the clinical development plan.

    • Designs clinical studies to meet the stated objectives.  Assures that clinical trial objectives fit with the clinical program strategy.

    • Ensure that documents (protocol, Informed Consent Document [ICD], etc) meet regulatory requirements and company policy and has been reviewed by IRB/IECs.

    • Provides medical input into country feasibility.

     

    Support study team

    • Provides clinical input to protocol/study team for monitoring guidelines, statistics analysis plans, ICDs, clinical review forms, data edit checks, data quality planning, as needed.

    • Develop and maintain peer to peer relationships with healthcare professionals at clinical trial sites.

    • Contributes to contract research organization / vendor selection to ensure study is conducted consistent with protocol requirements, clinical plan expectations, and study timelines; this includes ensuring medical/technical requirements for data integrity are applied.

    • Works with study team to ensure high quality of data, e.g. appropriate patient population, adequacy of clinical assessments etc., as study is ongoing.

    • Conducts medical review and interpretation of efficacy and safety data from clinical trials; this includes delivery of top-line report in collaboration with study statistician, and delivery of clinical study report in collaboration with medical writer; accountable for overall quality and timeliness of analysis and reporting.

    • Responsible for medical and scientific validity of study report, especially conclusions regarding efficacy and safety.  Responsible for disclosure of appropriate safety and efficacy data and conclusions (e.g. ClinicalTrials.gov, EudraCT.).

    • Provides protocol specific training to study team, investigators, clinical research associate, and others.

    • Interact with healthcare professionals at sites during the conduct of the study to enable quality, compliance and patient safety at the trial, site and patient level.

    • Interacts with Data Monitoring Committees and Steering Committees as required.

    • Coordinates medical opinions with other physicians globally to ensure consistency.

    • Notify appropriate study team personnel of the need to inform investigators of any changes in research activity and any significant new adverse events.

    • Monitor investigator compliance with protocol and regulatory requirements.

    • Support study team in issues resolution, study closeout, audit responses, inspection readiness, etc.

     

    Supports the program team:

    • Authors clinical sections of regulatory documents (e.g. Investigator Brochure, Annual Reports, Investigational New Drug sections, Clinical Study Reports).

    • May co-author abstracts, posters, presentations and publications.

    • Acts as clinical representative in in-licensing activities such as due diligence reviews and reports.

    • As a key member of the Program team, interfaces with discovery, safety sciences, statistics, clinical pharmacology, commercial, regulatory, outcomes research, Development Operations and other members of the extended project team(s).

    • Responsible for the on-time and within-budget execution of protocols.

     

    Interact with regulatory authorities, key opinion leaders, and principal investigators:

    • Support Regulatory Authority interactions accountable for providing responses.

    • Liaise with Key Opinion Leaders and Principal Investigators in countries to build a Key Opinion Leaders /Principal Investigators network for new trials.

     

    The preferred candidate has the following education and experience:

    MD with pharmaceutical experience, or similar drug development experience in an academic setting.   Our preferred candidate will have experience in these areas:

    • Infectious Diseases
    • Pharmacovigilance
    • Clinical Development
    • Working with KOLs and advisory boards
    • Challenging the status quo and asking probing questions
    • Timely project execution
    Apply
  • MD, Clinical Development, Oncology VETERANS WANTED

    Clinical Development

    Plymouth Meeting, PA

    Company Profile

    Inovio is taking immunotherapy to the next level in the fight against cancer and infectious diseases. The company is advancing a growing clinical and preclinical stage product pipeline. Partners and collaborators include MedImmune, Roche, University of Pennsylvania, DARPA, GeneOne Life Science, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, and University of Manitoba. For more information, visit www.inovio.com.

    Job summary

    Inovio is hiring an MD to work in our Plymouth Meeting office.   This position provides strategic contribution and support for Inovio Pharmaceuticals while collaborating with respective Commercial, Biostatistics, Epidemiology, and Clinical colleagues in the development and implementation of components of an External Engagement, Data Generation and Lifecycle program for multiple assets.  This position is a great entry point into Clinical Development in the Pharmaceutical Industry.

    These are the primary areas of responsibility:

    Accountable for safety across the study:

    • Provide study team with medical advice for all medical issues during risk assessment and mitigation planning to enable quality, compliance and patient safety at the trial, site and patient level.

    • Ensures development of and adherence to safety review.  Performs and documents regular review of individual subject safety data, and performs review of cumulative safety data. 

    • Monitor study safety issues and provide input to serious adverse events (SAEs) reports.

    • Participates in Safety Review to evaluate medical benefits/risks to support targeted clinical indications.

    • Reviews literature as needed to respond to safety questions.

    • Communicates safety information to sites across the study and provides responses to questions on safety.

     

    Protocol design and strategy:

    • Provide medical input during development and updates to the clinical development plan.

    • Designs clinical studies to meet the stated objectives.  Assures that clinical trial objectives fit with the clinical program strategy.

    • Ensure that documents (protocol, Informed Consent Document [ICD], etc) meet regulatory requirements and company policy and has been reviewed by IRB/IECs.

    • Provides medical input into country feasibility.

     

    Support study team

    • Provides clinical input to protocol/study team for monitoring guidelines, statistics analysis plans, ICDs, clinical review forms, data edit checks, data quality planning, as needed.

    • Develop and maintain peer to peer relationships with healthcare professionals at clinical trial sites.

    • Contributes to contract research organization / vendor selection to ensure study is conducted consistent with protocol requirements, clinical plan expectations, and study timelines; this includes ensuring medical/technical requirements for data integrity are applied.

    • Works with study team to ensure high quality of data, e.g. appropriate patient population, adequacy of clinical assessments etc., as study is ongoing.

    • Conducts medical review and interpretation of efficacy and safety data from clinical trials; this includes delivery of top-line report in collaboration with study statistician, and delivery of clinical study report in collaboration with medical writer; accountable for overall quality and timeliness of analysis and reporting.

    • Responsible for medical and scientific validity of study report, especially conclusions regarding efficacy and safety.  Responsible for disclosure of appropriate safety and efficacy data and conclusions (e.g. ClinicalTrials.gov, EudraCT.).

    • Provides protocol specific training to study team, investigators, clinical research associate, and others.

    • Interact with healthcare professionals at sites during the conduct of the study to enable quality, compliance and patient safety at the trial, site and patient level.

    • Interacts with Data Monitoring Committees and Steering Committees as required.

    • Coordinates medical opinions with other physicians globally to ensure consistency.

    • Notify appropriate study team personnel of the need to inform investigators of any changes in research activity and any significant new adverse events.

    • Monitor investigator compliance with protocol and regulatory requirements.

    • Support study team in issues resolution, study closeout, audit responses, inspection readiness, etc.

     

    Supports the program team:

    • Authors clinical sections of regulatory documents (e.g. Investigator Brochure, Annual Reports, Investigational New Drug sections, Clinical Study Reports).

    • May co-author abstracts, posters, presentations and publications.

    • Acts as clinical representative in in-licensing activities such as due diligence reviews and reports.

    • As a key member of the Program team, interfaces with discovery, safety sciences, statistics, clinical pharmacology, commercial, regulatory, outcomes research, Development Operations and other members of the extended project team(s).

    • Responsible for the on-time and within-budget execution of protocols.

     

    Interact with regulatory authorities, key opinion leaders, and principal investigators:

    • Support Regulatory Authority interactions accountable for providing responses.

    • Liaise with Key Opinion Leaders and Principal Investigators in countries to build a Key Opinion Leaders /Principal Investigators network for new trials.

     

    The preferred candidate has the following education and experience:

    MD with pharmaceutical experience, or similar drug development experience in an academic setting.   Our preferred candidate will have experience in these areas:

    • Immuno-Oncology
    • Pharmacovigilance
    • Clinical Development
    • Working with KOLs and advisory boards
    • Challenging the status quo and asking probing questions
    • Timely project execution
    Apply
  • Program Manager, Drug Development

    Alliance and Program Management

    Plymouth Meeting, PA

    Company Profile

    Inovio is taking immunotherapy to the next level in the fight against cancer and infectious diseases. We are the only immunotherapy company that has reported generating T cells in vivo in high quantity that are fully functional and whose killing capacity correlates with relevant clinical outcomes with a favorable safety profile. With an expanding portfolio of immune therapies, the company is advancing a growing preclinical and clinical stage product pipeline. Partners and collaborators include MedImmune, Regeneron, Genentech, The Wistar Institute, University of Pennsylvania, DARPA, GeneOne Life Science, Plumbline Life Sciences, ApolloBio Corporation, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, and Laval University. For more information, visit www.inovio.com.

    Job summary

    Working with the company’s product development teams, this position will support the discovery, development and life cycle management of candidate immunotherapy products.  This position will provide program management support for Discovery, pre-clinical and clinical product development activities, partnering with external collaborators as well as internal functional area groups.  The candidate will be responsible for the facilitation of team meetings, management of timelines, and periodic written and oral communications.  The position will support execution of program plans and serve as a key interface between a number of cross-functional areas within Research and Development, as such prior project management experience with the process and stages of vaccine and therapeutic product development from discovery/pre-clinical to late stage development is a critical skill. 

    Essential job functions and duties

    • Provide support and coordination across functional areas to enable integrated delivery of immunotherapy development programs and associated projects
    • Create and monitor project plans and timelines, and update work plans as appropriate to meet changing needs and requirements
    • Partner with the team to proactively Identify and highlight risks and issues within the project; work with the team to devise and implement effective risk mitigation strategies
    • Support development of tools and processes to increase efficiencies of program management and program execution
    • Facilitate communications between team members and stakeholders in a timely and clear fashion
    • Facilitate and manage team meetings
    • Partner with functional area leaders on resource planning requirements for timely completion of projects

    Minimum requirements

    • Required education: Bachelor’s degree.
    • Must have pharmaceutical or biopharmaceutical experience.
    • Area(s) of expertise desired: Biology, Immunology, Bioengineering, Cell or Molecular Biology.
    • Experience with vaccines is preferred
    • Experience in drug/ vaccine/ immunotherapy/ oncology product development is desired
    • Strong relationship building, communications and stakeholder management skills
    • Experience managing government/non-government contract and working with multi-institution teams (Academics, Public and Private sector organizations) is desired
    • Experience in development of medical injection devices is desired
    • Strong oral and technical/medical writing capability
    • Demonstrated attention to detail
    • 3-6 years of pharmaceutical industry experience is preferred
    • Project management professional certification is desired but not essential
    • Demonstrated ability to work both independently and in a team-oriented, collaborative environment
    • Can conform to shifting priorities, demands and timelines

    Disclaimer

    Inovio Pharmaceuticals, Inc. is committed to a policy of equal employment opportunity. In keeping with our policy, Inovio will recruit, hire, train and promote into all job titles the most qualified individuals, without regard to race, color, creed, gender, religion, marital status, registered domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws.

    A current US work authorization is required.  The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Inovio offers an attractive benefits package and is an equal opportunity employer. 

    Apply
  • Program Manager, Drug Development (bilingual English / Mandarin)

    Alliance and Program Management

    Plymouth Meeting, PA

    Company Profile

    Inovio is taking immunotherapy to the next level in the fight against cancer and infectious diseases. We are the only immunotherapy company that has reported generating T cells in vivo in high quantity that are fully functional and whose killing capacity correlates with relevant clinical outcomes with a favorable safety profile. With an expanding portfolio of immune therapies, the company is advancing a growing preclinical and clinical stage product pipeline. Partners and collaborators include MedImmune, Regeneron, Genentech, The Wistar Institute, University of Pennsylvania, DARPA, GeneOne Life Science, Plumbline Life Sciences, ApolloBio Corporation, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, and Laval University. For more information, visit www.inovio.com.

    Job summary

    Working with the company’s product development teams, this position will support the discovery, development and life cycle management of candidate immunotherapy products.  This position will provide program management support for Discovery, pre-clinical and clinical product development activities, partnering with external collaborators as well as internal functional area groups.  The candidate will be responsible for the facilitation of team meetings, management of timelines, and periodic written and oral communications.  The position will support execution of program plans and serve as a key interface between a number of cross-functional areas within Research and Development, as such prior project management experience with the process and stages of vaccine and therapeutic product development from discovery/pre-clinical to late stage development is a critical skill. 

    Essential job functions and duties

    • Provide support and coordination across functional areas to enable integrated delivery of immunotherapy development programs and associated projects
    • Create and monitor project plans and timelines, and update work plans as appropriate to meet changing needs and requirements
    • Partner with the team to proactively Identify and highlight risks and issues within the project; work with the team to devise and implement effective risk mitigation strategies
    • Support development of tools and processes to increase efficiencies of program management and program execution
    • Facilitate communications between team members and stakeholders in a timely and clear fashion
    • Facilitate and manage team meetings
    • Partner with functional area leaders on resource planning requirements for timely completion of projects

    Minimum requirements

    • Required education: Bachelor’s degree.
    • Must have pharmaceutical or biopharmaceutical experience.
    • Bilingual in English and Mandarin
    • Area(s) of expertise desired: Biology, Immunology, Bioengineering, Cell or Molecular Biology.
    • Experience with vaccines is preferred
    • Experience in drug/ vaccine/ immunotherapy/ oncology product development is desired
    • Strong relationship building, communications and stakeholder management skills
    • Experience managing government/non-government contract and working with multi-institution teams (Academics, Public and Private sector organizations) is desired
    • Experience in development of medical injection devices is desired
    • Strong oral and technical/medical writing capability
    • Demonstrated attention to detail
    • 3-6 years of pharmaceutical industry experience is preferred
    • Project management professional certification is desired but not essential
    • Demonstrated ability to work both independently and in a team-oriented, collaborative environment
    • Can conform to shifting priorities, demands and timelines

    Disclaimer

    Inovio Pharmaceuticals, Inc. is committed to a policy of equal employment opportunity. In keeping with our policy, Inovio will recruit, hire, train and promote into all job titles the most qualified individuals, without regard to race, color, creed, gender, religion, marital status, registered domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws.

    A current US work authorization is required.  The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Inovio offers an attractive benefits package and is an equal opportunity employer. 

    Apply
  • Senior Clinical Scientist or Clinical Program Manager

    Clincal Operations

    Plymouth Meeting, PA

    Company Profile

    Inovio is a late-stage biotechnology company focused on the discovery, development, and commercialization of DNA immunotherapies that transform the treatment of cancer and infectious diseases. Inovio is taking immunotherapy to the next level in the fight against cancer and infectious diseases. Inovio has reported generating T cells in vivo in high quantity that are fully functional and whose killing capacity correlates with relevant clinical outcomes with a favorable safety profile. With an expanding portfolio of immune therapies, the company is advancing a growing preclinical and clinical stage product pipeline. Partners and collaborators include MedImmune, Regeneron, Roche/Genentech, ApolloBio Corporation, The Wistar Institute, University of Pennsylvania, the Parker Institute for Cancer Immunotherapy, CEPI, DARPA, GeneOne Life Science, Plumbline Life Sciences, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, and Laval University. For more information, visit www.inovio.com.

    Job Summary

    The person in this position will be crucial player in working with Inovio’s program partners including CEPI in leading clinical trials to develop vaccines with the goal of preventing  emerging infectious diseases such as (MERS and LASSA) in Africa and the Middle East.  S/he will play a critical role in ensuring that these trials are executed in a way that meets ICH, GCPs, and local requirements. S/he will help ensure these trials achieves maximum productivity, efficiency, and compliance to international and local standards, including processes associated with study start-up, conduct, and close-out. S/he will achieve these objectives through:

     a.) Providing a day-to-day support to clinical project (in coordination with relevant field-based and/or central team project leaders

     b.) Coordination and communication between Inovio and field-based (clinical site and local MOH) personnel.

     c.) The development or refinement of context-appropriate study management tools and training resources to support the conduct of clinical trials.

    d.) Effective and collaborative management of Inovio’s program partners (e.g., CEPI, etc.).

     e.) Provide capacity-building and technical guidance to Inovio’s central team personnel. 

     

    Essential Job Functions and Duties

    • Prepare and finalize project and study-related documents including: informed consent forms, clinical trial outlines, monitoring plans, synopses, protocols and amendments, IND annual updates and clinical summaries, as required.
    • Select investigators and study sites.
    • Identify and respond to site and study related issues and recommend corrective actions and/or escalations.
    • Coordinate the design, format and content of CRFs, study guides, study reference binders, patient diaries, and forms including participating in the EDC and IXRS specification process and UAT.
    • Ensure that CRF data queries are resolved.
    • Coordinate and manage Investigational Product including overall accountability and reconciliation.
    • Prepare study budgets and timelines.
    • Manage project timelines and vendor performance to meet departmental and corporate goals.
    • Manage study budget and payment process for all clinical trial vendors including investigative sites.
    • Monitor and track clinical trial progress and provide status update reports.
    • Manage all clinical trial vendors.
    • Responsible for selection of CRO study staff and coordinating training including documentation.
    • Duties may also include oversight of clinical trial operations as performed by a CRO or other external consultants.
    • Hire, train and oversee study field monitors (e.g., review of all trip reports) and provide guidance on site issues.
    • Lead the planning of investigator meetings and making presentations, as required.
    • Lead the review of clinical data at the CRF, data listing, and report table levels.
    • Represent Clinical Operations at the project team level for individual studies, as appropriate.
    • Partner with other research and development groups to achieve deliverables.
    • Participate in Site Initiation Visits (SIVs) as required.
    • Co-monitoring of regional sites for adherence to protocol and GCP as required.
    • Travel (Africa and Middle East) as required to carry out responsibilities.
    • Identify and escalate site, vendor and study related issues, as appropriate.
    • Participate in clinical and department settings, including attending additional meetings as required, interacting in a positive and professional manner.
    • Perform other duties as assigned.

     

    Minimum Requirements

    • BA/BS in related field. 
    • Experience in conducting trials in Africa and Middle East.
    • Minimum 8 years clinical drug development experience.
    • Work experience in NGO settings is preferred.
    • Experience in personnel management.
    • Experience in CRO selection and management, including drafting request for proposals (RFPs), bidding process, etc.
    • Experience in managing infectious disease clinical trials (emerging infectious diseases preferred).
    • Knowledge of FDA regulatory requirements and medical practice/techniques and terminology.
    • Knowledge and understanding of local (Africa and Middle East) regulatory and EC requirements for clinical trials. 
    • Ability to work within a team, including leadership skills.
    • Ability to organize and prioritize multiple tasks.
    • Excellent communication and interpersonal skills.
    • Attention to detail, organization, and problem-solving skills.
    • 30% International travel to Africa and Middle East.
    • Proficient in MS Office.

    Disclaimer

    Inovio Pharmaceuticals, Inc. is committed to a policy of equal employment opportunity. In keeping with our policy, Inovio will recruit, hire, train and promote into all job titles the most qualified individuals, without regard to race, color, creed, gender, religion, marital status, registered domestic partner status, age, national origin or ancestry, veteran status, physical or mental disability, medical condition including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws.

    A current US work authorization is required. The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Inovio offers an attractive benefits package and is an equal opportunity employer. 

    Apply
  • Sr. Scientist/Lead, Biomarkers

    R&D

    Plymouth Meeting, PA

    Company Profile

    Inovio is a late-stage biotechnology company focused on the discovery, development, and commercialization of DNA immunotherapies that transform the treatment of cancer and infectious diseases. Inovio is taking immunotherapy to the next level in the fight against cancer and infectious diseases. Inovio has reported generating T cells in vivo in high quantity that are fully functional and whose killing capacity correlates with relevant clinical outcomes with a favorable safety profile. With an expanding portfolio of immune therapies, the company is advancing a growing preclinical and clinical stage product pipeline. Partners and collaborators include MedImmune, Regeneron, Roche/Genentech, ApolloBio Corporation, The Wistar Institute, University of Pennsylvania, the Parker Institute for Cancer Immunotherapy, CEPI, DARPA, GeneOne Life Science, Plumbline Life Sciences, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, and Laval University. For more information, visit www.inovio.com.

    Job summary

    This position is responsible for pursuing biomarker and diagnostic strategies to support the development and commercialization of Inovio’s immunotherapeutics, including contribution to the development of companion diagnostics.  This position will serve as the point of contact for all aspects of clinical biomarker strategy providing scientific expertise from the ground up and guiding the function of the Biomarker division of the Immunology and Biomarkers group, including managing direct reports.

    Essential job functions and duties

    • Review, assess and select vendors for use in clinical biomarker exploration, clinical biomarker validation and companion diagnostic construction
    • Review of raw and computed data from microRNA profiling of subject samples from Inovio’s clinical trials, including identification of signals specific to Inovio’s treatments
    • Construction of validation studies for signal confirmation
    • Contribution to the construction of companion diagnostics for clinical use with Inovio’s products
    • Use of Microsoft Excel and GraphPad Prism to sort and generate tables and graphical representations of analyzed data for presentation within the group and to other groups within Inovio
    • Collect, analyze and present data at both internal meetings with other Inovio scientists and collaborators
    • Other functions may be required based on skill set and business needs.

    Minimum requirements

    •  PhD in life sciences (oncology, immunology, pathology, molecular biology, cell biology or related field) and 3+ year’s industry experience in a clinical setting or Master’s degree with 5+ years industry experience
    •  Experience in analysis of large microRNA datasets is required
    •  Working knowledge of laboratory techniques surrounding PCR, RNAseq and target/probe hybridization is required
    •  Demonstrable experience with record keeping and quality measures is required
    •  Technical proficiency, ability to learn new techniques quickly, effective problem solving and critical thinking skills required
    •  Previous experience with Microsoft excel in data formatting is required
    •  Knowledge of biostatistics is a plus
    •  Previous experience with development of a companion diagnostic is a plus
    •  Previous experience with DNA methylation profiling of human samples is a plus
    •  Ability to consistently meet deadlines.
    •  Ability to work in a team environment.
    •  Excellent communication, interpersonal and organizational skills.

    Disclaimer

    Inovio Pharmaceuticals, Inc. is committed to a policy of equal employment opportunity. In keeping with our policy, Inovio will recruit, hire, train and promote into all job titles the most qualified individuals, without regard to race, color, creed, gender, religion, marital status, registered domestic partner status, age, national origin or ancestry, veteran status, physical or mental disability, medical condition including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws.

    A current US work authorization is required. The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Inovio offers an attractive benefits package and is an equal opportunity employer. 

    Apply

Inovio Pharmaceuticals, Inc. is committed to a policy of equal employment opportunity. In keeping with our policy, Inovio will recruit, hire, train, and promote into all job titles the most qualified individuals, without regard to race, color, creed, protected veteran status or disability, gender, religion, marital status, registered domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws.

Important notice to employment businesses/agencies:

Inovio does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Inovio’s Human Resources Department to obtain prior written authorization before referring any candidates to Inovio. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/agency and Inovio. In the absence of such written authorization being obtained, any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Inovio. Inovio shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.