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

  • Accounts Payable Clerk

    Accounting and 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, 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 Accounts Payable Clerk performs routine accounting tasks such as processing vendor invoices and employee expense reports, reconciling vendor statements, and interacting with internal and external customers.

    Essential job functions and duties

    • Perform sorting, coding and matching of invoices/receipts and obtain appropriate approvals
    • Accurately and timely enter invoices and PO receipts into accounting system
    • Accurately and timely process payment of company-issued credit cards
    • Comply with SOX and other operational business controls
    • Process and audit expense reports for accuracy and appropriate approval
    • Reconcile vendor statements
    • Provide back-up to functions such as generating check runs and processing wire payments
    • Distribute signed checks as required
    • Partner with internal and external customers to troubleshoot and drive resolution of problem invoices
    • Assist with the reconciliation of the A/P subsidiary ledger to the general ledger
    • Assist/Perform ad hoc duties as needed

    Minimum requirements

    • Associates degree in accounting preferred; or an equivalent combination of education, training and/or experience from which comparable knowledge, skills and abilities have been attained
    • Proficient data entry and Excel skills
    • Excellent time management skills
    • High degree of accuracy and attention to detail
    • Ability to meet assigned deadlines
    • Ability to tackle competing priorities when presented with urgent and non-routine tasks
    • Excellent communication and interpersonal skills
    • Ability to act and operate independently with minimal daily direction from manager to accomplish objectives
    • Ability to work cooperatively and collaboratively with all staff levels

    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
  • Buyer - R&D Laboratory and Device

    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, 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

    Buyer will be a well-organized individual with excellent communication and interpersonal skills. This position interfaces primarily with the research and development (R&D) department but will have interaction with all levels of the company. The Buyer is responsible for the purchase and management of R&D engineering and production material inventory levels and flow to ensures that raw material components, lab supplies, chemicals, animals, equipment and other department needs are available to satisfy the scheduled requirements. In addition, the buyer will be expected to develop purchasing control documentation in compliance with the current Quality Policy and standards.

    Essential job functions and duties

    • Assist business partners, engineers and scientists with their supply, equipment and service procurement needs.
    • Initiate contact with prospective vendors, ensure NDA’s are in place, negotiate pricing, review quotes, product availability, terms of sales and lead times.
    • Qualify vendors by submitting and receiving Quality department documentation and analyzing supplier operations.
    • Prepare and process requisitions and purchase orders for lab supplies, chemicals, animals, equipment, tools, raw materials, packaging materials, services and/or supplies necessary for operation of the department.
    • Review purchase order claims and contracts for conformance to company policy and enforce every contract term set with each vendor.
    • Analyze market and delivery systems in order to assess present and future material availability.
    • Follow up on orders placed, verify delivery, approve payment and maintain necessary records.
    • Participate in the development of specifications for equipment, products or substitute materials.
    • Resolve vendor or contractor grievances and claims against suppliers.
    • Assist in the technical transfer of design/manufacturing specifications for new products and/or assemblies to suppliers for initial build(s).
    • Execute administrative tasks assigned by leadership.

    Minimum requirements

    • Bachelor’s degree required or an equivalent combination of education, training and/or experience from which comparable knowledge, skills and abilities have been attained
    • 1-3 years of Purchasing and Supply Chain experience. Prior scientific research laboratory purchasing experience preferred
    • Strong written, verbal, and oral communication
    • Strong negotiation skills
    • Strong computer skills and advanced Microsoft products skills
    • ERP experience a plus
    • Ability to read and interpret Engineering drawings and specifications preferred
    • Strong analytical skills and the ability to interpret and communicate technical specifications
    • Strong work ethic and team player
    • Lean Manufacturing, TCO, Six Sigma or other Continuous Improvement experience preferred
    • Experience with FDA GMP Part 820, CE, UL and ISO 13485 preferred.
    • Proficient with writing SOPs and Purchasing documentation

    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
  • Senior Electrical Engineer (Temporary)

    Engineering 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, 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 Senior Electrical Engineer is responsible for designing circuits, writing technical documentation and using a variety of test equipment.

    Essential job functions and duties

    • Evaluate, investigate and design electrical systems, products, components, and applications; applying knowledge of electronics, software manufacturing processes and materials.
    • Design analog circuits using discrete components such as op-amps, amplifiers, passive components, A/D and D/A converters, opto-electrical devices, etc.
    • Use laboratory tools such as oscilloscopes, function generators, power supplies and multi-meters.
    • Develop and test embedded controller or microprocessor systems.
    • Perform tolerance analysis calculations and studies.
    • Design servo motor control and feedback.
    • Coordinate PCB and PCBA manufacturing methodologies and processes.
    • Complete projects by training and guiding technicians.
    • Develop products from concept through validation and manufacturing.
    • Generate product development documentation: plans, specifications, procedures (test, manufacturing and QC), reports, design reviews and validation.
    • Provide manufacturing support for production, QC, and investigations.
    • Perform Risk Analysis such as DFMEA’s.
    • Represent Engineering in CCB meetings
    • Review and sign off change orders for Engineering
    • Generate Design Control, Engineering and Manufacturing documents.
    • Verify, validate and document product designs.
    • Create database parts for OrCAD CIS
    • Ensure task completion by establishing priorities and reaching compromise with team members and functional manager
    • Complete other engineering duties as assigned.

    Minimum requirements

    • B.S. degree in Electrical Engineering.
    • Minimum 5 years of electrical engineering experience in medical or other regulated industry.
    • Programming skills: assembly, C. FDA regulation experiences.
    • Interact with closely with production, R&D, and marketing to support existing and new products.
    • Vendors, contract manufacturers, consultants, sales and service organizations.
    • Support instrument research, development and manufacturing efforts.
    • Familiarity with design tools, i.e. OrCAD CIS, LTSpice, Allegro, PADS.
    • Excellent teamwork, written and verbal communication skills required.
    • Proficient with standard Microsoft Office tools.
    • Follow processes and procedures for developing and supporting products.
    • Involves typical office activities and lab bench top technician tasks.

    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
  • Systems Administrator

    Information Technology

    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 Systems Administrator (SA) is responsible for effective provisioning, installation/configuration, operation, and maintenance of systems hardware and software and related infrastructure. This individual participates in technical research and development to enable continuing innovation within the infrastructure. This individual ensures that system hardware, operating systems, software systems, and related procedures adhere to organizational policies and practices.

    This individual assists project teams with technical issues in the Initiation and Planning phases of the standard Project Management Methodology. These activities include the definition of needs, benefits, and technical strategy within the project life-cycle; including support of operations staff in executing, testing and rolling-out the solutions. Participation on projects is focused on smoothing the transition of projects from development staff to production staff by performing operations activities within the project life-cycle.

    Essential job functions and duties

    SA Engineering and Provisioning

    • Create Systems Administrator-related solutions for various projects and operational needs.
    • Install new / rebuild existing servers in a virtual environment using Vmware 6.
    • Periodically configure hardware, peripherals, services, settings, directories, storage, etc. in accordance with standards and project/operational requirements.
    • Install and configure systems that support infrastructure applications.
    • Develop and maintain installation and configuration procedures.
    • Contribute to and maintain system standards.
    • Research and recommend innovative, and where possible, automated approaches for system administration tasks. Identify approaches that leverage our resources and provide economies of scale.

    Operations and Support

    • Perform daily system monitoring, verifying the integrity and availability of all hardware, server resources, systems and key processes, reviewing system and application logs, and verifying completion of scheduled jobs such as backups.
    • Perform regular security monitoring to identify any possible intrusions.
    • Perform daily backup operations in a mixed back up environment using Commvault and Arcserve UDP, ensuring all required file systems and system data are successfully backed up to the appropriate media. Perform regular file archival and purge as necessary. 
    • Perform needed Active Directory Moves, adds and changes per request. 
    • Provide Tier III/other support per request from other team members.
    • Repair and recover from hardware or software failures.  Coordinate and communicate with impacted constituencies.

    Maintenance

    • Apply OS patches and upgrades on a regular basis, and upgrade administrative tools and utilities. Configure / add new services as necessary.
    • Upgrade and configure system software that supports infrastructure applications or Asset Management applications per project or operational needs.
    • Perform periodic performance reporting to support capacity planning.
    • Perform ongoing performance tuning, hardware upgrades, and resource optimization as required.  Configure CPU, memory, and disk partitions as required.
    • Maintain data center environmental and monitoring equipment.
    • Create Change Management documentation with supporting documentation for all production changes.

    Minimum requirements

    • Bachelor degree in the field of computer science, MIS, computer information systems or information systems, or an equivalent combination of education and experience.
    • Four to six years system administration experience.
    • Experience in the following is required:
    1. Administering and building in a Vmware 6 environment.
    2. Creating and maintaining a SCCM environment for server patching and groups deployments.
    3. Creating, deploying and maintaining software images in a SCCM environment.
    4. Maintaining and deploying Windows and other software patching.
    5. Use of Commvault or similar backup environment.
    6. Administration of a Microsoft Exchange environment
    7. Administration and maintenance of VOIP services in a Vonage environment
    8. Administration of a Cisco / Meraki multi-site environment
    9. Cisco Certification desired
    10. Administration of a distributed storage environment.
    11. Tegile preferred
    12. Administration of  business Communication systems
    13. DFS storage and Maintenance
    14. Security maintenance. IDS/IPS administration

    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
  • Clinical Program 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.

    Minimum requirements

    • Bachelor/Masters degree.
    • At least 5 years of clinical research experience. Regulatory affairs experience a plus.
    • Area(s) of expertise desired: Biology, Immunology, Bioengineering, Cell or Molecular Biology.
    • People Management experience 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
  • Clinical 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 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
  • Clinical Supply Associate

    Clinical

    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, 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 supporting the on-time delivery of clinical supplies for Inovio Pharmaceuticals.  Partner with other INOVIO clinical team members to ensure clinical trials are appropriately supplied with product; ensure inventory levels are maintained at depots and sites.  Provide study information/ updates and technical supply chain expertise to support various processes such as demand/ supply planning, IXRS development, implementation and management, and inventory management including allocation and distribution. Analyze clinical supply chain processes and associated processes, and contribute to improvement efforts.

    Essential job functions and duties

    • Supply Clinical Supplies Investigational Product including:
      • Active
      • Placebo
    • Manage inventory levels and distribution of Clinical Supplies:
      • Ensure country/site specific inventory levels are consistently maintained throughout the life cycle of the clinical trial.
      • Provide shipping forecast for budgeting and planning purposes.
      • Provide shipping requirements (e.g. temperature sensitive, temp monitor, pre-qualified shipper, ambient shipper, etc.) and review/approve distribution protocol with Distribution Depots.
      • Facilitate the retrieval of Import Permits if required; working with Distribution Depots, Regulatory Affairs and CRO.
      • Ensure Regulatory “green light” as well as “technical green light” (i.e. QA/ QP release) is in place prior to initial and re-supply shipments to clinical sites.
      • Track shipment (i.e. status) of clinical supplies.
      • Process manual ship requests for non-IXRS studies.
    • Clinical study team member
      • Participate in regular study meetings
      • Track appropriate approvals (i.e. expiry dating, country specific labels) and communicate progress to various team members such as CMO and QA.
    • IXRS team member
      • Participate in evaluation of IXRS vendors
      • Participate in URS review/ approval and UAT
      • Manage clinical supply inventory/ re-supply strategy in IXRS
      • Participate in regular IXRS team meetings
    • Review protocol, provide feedback, share info with Clinical Planning team; ensure Planning team is kept updated on any study changes that may affect IMP requirements
    • Provide guidance for returns for destruction (i.e. ensure site can provide Cert of Destruction, or provide return to depot information)
    • Perform Final IP reconciliation
    • Contribute to the Pharmacy Manual
    • Participate in Investigator Meetings

    Minimum requirements

    • Minimum2-3 years experience in the clinical supply chain or related field required
    • Inventory management experience required, 3 years minimum
    • Working knowledge of current GMP/GCP regulations required
    • IXRS experience desired
    • Distribution experience, including Cold Chain required
    • Experience in biopharmaceutical manufacturing preferred.
    • Demonstrated proficiency with Microsoft Excel and good working knowledge of other MS Office applications.
    • Demonstrated ability to manage multiple projects and priorities, and have strong data analysis, problem solving, and decision-making ability
    • Demonstrated ability to work with all organizational levels and work effectively in a team environment, demonstrate strong verbal and written communication skills
    • Demonstrated examples of a high level of personal initiative and ability to function autonomously with a strong sense of urgency, self-confidence, and comfort with new and rapidly changing situations and environments

    EDUCATION

    • Bachelors in Operations/Supply Chain Management, Engineering, or related Business field with 2 – 3 years experience in the supply chain field.

    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 Trials Associate (CTA)

    Clinical

    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. The company is advancing a growing clinical and preclinical stage product pipeline. Partners and collaborators include MedImmune, 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

    The Assistant, Clinical Trials (CTA) is responsible for supporting, under the direct supervision of the supervisor/Clinical Project Lead (CPL), clinical trial execution, externally sponsored research and program level activities as assigned within Clinical Operations at Inovio. This position assists in various tasks and projects related to clinical trials as well as basic, administrative duties such as ordering drugs and devices, maintaining milestone trackers and filing of essential documents of externally sponsored trials.

    Essential job functions and duties

    • Assist with filing and maintaining study files, investigator files, and study plans
    • Work with Clinical Project Lead to collect relevant study information on timelines, progress and resources
    • Assist in the development of clinical protocols, informed consent forms, clinical study reports, regulatory documents (e.g., IND, BLA, etc.), and other clinical documents.
    • Implement and maintain project processes and tracking systems. Generate and distribute status reports to management and other clinical team members
    • Assist with management of study timelines and study progress. Undertake defined responsibilities delegated by the Clinical Project Lead
    • Assist the CPL in the management and tracking of clinical supplies, including drug, devices, lab kits, etc.
    • Coordinate and support clinical team, consultant and vendor meetings
    • Assess meeting requirements and plan appropriately (e.g., arrange meeting room, schedules teleconference, distributes meeting agenda, prepares and distributes meeting minutes, etc.)
    • Complete assigned tasks in accordance with SOPs and guidelines, Good Clinical Practice (GCP), International Council on Harmonisation (ICH) guidelines and regulatory requirements for clinical trial management
    • Provide progress updates and summaries to CPL
    • Communicate study-related information to investigators and study staff as delegated by the CPL
    • Work with Clinical Data Management on assigned projects
    • Plan and participate in conduct of Investigator Meetings
    • Other tasks may be assigned based on skill sets and business need

    Minimum requirements

    • Bachelor’s degree
    • Area(s) of expertise desired: Biology, Immunology, Bioengineering, Cell or Molecular Biology. Experience with vaccines highly preferred
    • Years of experience required: Combination of 0-2 years of monitoring and/or 0-2 years of clinical trial management experience
    • MS Office Suite proficiency (Word, Outlook)
    • Excellent oral and written communication skills, attention to detail and ability to interact effectively with management and prioritize diverse projects for multiple disciplines
    • Working knowledge of FDA regulations/guidelines, ICH guidelines, and GCPs
    • Demonstrates an understanding of trial and protocol objectives
    • Some travel may be required

    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
  • 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
  • Regulatory Operations and Submissions Associate

    Clinical Development/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, 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 Associate, Regulatory Operations and Submissions will plan and lead the global regulatory submission process.  Additionally, the Associate will ensure compliant eCTD submissions and accurate, consistent and timely submission planning and tracking. The Associate will be responsible for formatting, publishing and QC at the document and submission level.

    Essential job functions and duties

    • Responsible for US and ex-US document-level publishing, formatting, and document quality control including: referencing, grammar/spelling/usage and style accuracy, check for consistency and mechanics.
    • Responsible for staying abreast of US, Harmonized (ICH) eCTD and ex-US guidances, and provide training as required.
    • Develop Regulatory Operations standards and processes for electronic publishing.
    • Manage tracking of all submissions
    • Create efficiencies within RegOps to enhance the quality of and timeliness of submissions
    • Serve as the primary RegOps lead for publishing, review, submission and archive of eCTD submissions, including amendments and original filings.
    • Collaborate with functional areas to streamline processes
    • Educate and train functional areas; educate teams about developing, updating, and maintaining Inovio’s submission processes and requirements.
    • Assists Regulatory Affairs
    • Other tasks may be assigned based on business needs.
    • Assists Regulatory Affairs and Clinical personnel with document level requirements and techniques for compliant upstream eCTD authoring

    Minimum requirements

    • Bachelor’s degree or equivalent industry experience.
    • Minimum of 3 years of Regulatory Operations experience within the Pharmaceutical Industry.
    • Working knowledge and experience in regulatory submissions and product life cycle management.
    • Proficient in the use of common Microsoft software programs.
    • Familiarity and/or experience developing eCTD-compliant documents and submissions.
    • Familiarity with CTD, ICH, GCP, and other standards.
    • Ability to simultaneously plan, coordinate and lead activities on multiple projects.
    • Ability to self-direct workload, including reprioritizing and delivery under tight 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, 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 Clinical 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.

    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
  • Sr. Clinical Scientist / Program 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 5 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

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.