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

  • Laboratory Assistant (Logistical Operations)

    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, 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 Laboratory Assistant provides assistance with lab management functions to support all aspects of research within the company. The position interfaces with multiple departments (R&D, engineering, accounting, quality) and performs general lab maintenance duties and recordkeeping.

    Essential job functions

    • Receive and inventory lab materials.
    • Monitor and process materials for proper disposal.
    • Prepare and pack research and development shipments, such as biologics and medical devices.
    • Perform general lab duties, such as autoclaving and dishwashing.
    • Report problems, issues and unexpected observations regarding safety and lab compliance.
    • Maintain lab equipment and equipment logs.
    • Assist lab users on issues with equipment and submit requests to service vendors.
    • Generate documentation and perform recordkeeping.
    • Interface with multifunctional team members, including R&D, engineering, accounting, quality assurance and others.
    • Other duties as assigned.

    Minimum requirements

    • A.S. degree in biological sciences preferred or an equivalent combination of education, training and/or experience from which comparable knowledge, skills and abilities have been attained.
    • 0-1 year of experience within an academic or industry lab setting.
    • Excellent oral communication/interpersonal skills.
    • Ability to solve complex problems.
    • Capable of managing multiple priorities in a fast-paced environment.
    • Function with a high degree of independence as well as be a team player.

    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
  • QA Associate/Training Coordinator

    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, 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 QA Associate has the primary responsibility for supporting the R&D Training Program by scheduling the new hire orientation, and other Quality Systems and compliance training as needed; establishing and maintaining job role training matrices; initiating new hire training and facilitating completion of new/revised document training; as well as being responsible for IQMS R&D training coordination activities.

    Essential job functions and duties:

    • IQMS R&D Training Coordination:
    • Maintain the R&D training requirements (both course and document) and person records in the IQMS.
    • Collaborate with document owners to determine the appropriate training roles and competency level for new or revised documents in the IQMS.
    • Create/modify positions and training roles as needed.
    • Manually certify courses upon receipt of completed training records.
    • Create/modify courses as needed.
    • R&D Training Program:Facilitate the new hire process:
    • Initiate the IQMS Access form and collaborate with supervisor to determine appropriate training role(s).
    • Initiate IQMS Fundamentals training and ensure completion of the IQMS Access form.
    • Schedule GLP/GCLP orientation and GDP training sessions.
    • Coordinate instructor-led training with the appropriate trainer(s).
    • Send welcome email and ensure updated resume is provided in appropriate timeframe.
    • Obtain copy of signed Job Description from HR
    • Create and file the employee training file once all documents are obtained.
    • Maintain the Qualified Trainer/Competency Level spreadsheet.
    • Maintain training records by filing new hire qualification requirements and completed training records in document archive room.
    • Perform annual trainings for GLP best practices, as well as, trainings for quality processes and systems.
    • Participation in other standard QA responsibilities:
    • Audits, inspections, document release, archiving, issuing deviations, CAPA monitoring, etc.

    Minimum requirements

    • Associate's degree (AA) from a two year college or an equivalent combination of education, training and/or experience from which comparable knowledge, skills and abilities have been attained. Bachelor’s degree preferred.
    • 1-2 years of relevant experience with an EDMS system.
    • Knowledge and proficiency in the use of Pilgrim or similar document control/change control software.
    • Knowledge and proficiency in application of Quality Systems per 21 CFR 58, GCLP and GMP is desirable.
    • Knowledge of cGMP and GLP/GCLP regulations and good documentation practices.
    • Ability to work independently, within prescribed guidelines, or as a team member.
    • Demonstrated ability to follow detailed directions in a GxP environment.
    • Familiarity with Microsoft Office applications.
    • Detail oriented and strong written and verbal communication skills.
    • Ability to communicate and train others in new processes.

    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
  • Senior Associate, Quality Assurance (Device GMP training)

    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, 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 Associate, Quality Assurance (QA) performs a wide variety of duties, including but not limited to, supporting the daily QA departmental operations, supporting product flow through the production floor, and performing various types of documentation reviews. The Senior Associate, QA is responsible for supporting the Quality System to ensure compliance to applicable regulations and standards, QSR, ISO, MDD program as needed and is required to possess strong computer skills and a high-level of written and verbal interactive communication skills.  The position requires familiarity with Change Control, Temporary Deviation, Engineering Testing and Validation systems. The Senior Associate, QA provides support to ensure Documentation SOPs and practices conform to regulatory standards and that the processes to release and control documentation are defined and controlled. The position is responsible for reviewing, assisting and verifying the generation of metrics for upper management review.

    Essential job functions and duties

    • Maintain documentation for Quality System.
    • Update and create Standard Operating Procedures for Quality System related activities.
    • Provide assistance in ensuring that departmental records, Quality Management System procedures, specifications, corporate standards, external standards (e.g. ISO 13485, Vigilance) comply with FDA Quality Systems Regulations (QSR’s) and applicable foreign regulations (e.g. Medical Device Directive).
    • Manage and maintain the Document Control Archive Room.
    • Review and log documents ready for archive.
    • Manage and maintain employee training records in the company EDMS
    • Perform data input into the computer system for data collection purposes used to identify quality trends and training monitoring.
    • Assist with Change Order processing and release activities.
    • Communicate change order information and interface with Manufacturing, Engineering, Quality, Clinical and Research & Development.
    • Perform other related tasks as assigned.

    Minimum requirements

    • Associate's degree (AA) from a two year college or an equivalent combination of education, training and/or experience from which comparable knowledge, skills and abilities have been attained. Bachelor’s degree preferred.
    • 2-4 years of experience in medical device or pharmaceutical/biotech industry, with working knowledge of FDA and ISO regulations.
    • 2-4 years of experience on change orders, deviations, complaints and validation process.
    • 1-2 years of experience with general QA work and training management.
    • Ability to read, analyze, and interpret technical procedures and regulations. Ability to write reports and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers and the general public.
    • Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
    • Knowledge of Document Control principles.
    • 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 individually and in a team environment.

    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 Buyer

    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

    The Senior Buyer interfaces primarily with the medical device manufacturing, engineering and laboratory departments but has interaction with all levels of the company. The Senior Buyer is responsible for the purchase and management of engineering and production material inventory levels and flow to ensure raw material components, lab supplies, chemicals, animals, equipment, services and other department needs are available to satisfy the business partner requirements. In addition, the Senior Buyer is expected to develop and/or maintain purchasing control documentation in compliance with the current Quality Policy, cGMP and additional standards.

    Essential job functions and duties

    • Collaborate with internal customers to assure supply continuity
    • Identify vendor management best practices and train the organization
    • Institute efficient processes for procurement of services and direct and indirect material
    • Assure contract compliance to company requirements, policy and enforcement
    • Prepare bids/proposals, supporting data, comparisons, recommendations and justifications in the effort to award contracts or purchase orders
    • Interface directly with staff and suppliers to resolve order status, discrepancies, past due items and schedule/date changes
    • Coordinate details of defective and returned materials with suppliers, Quality Assurance and others to determine root cause, initiate and follow-up on corrective actions
    • Analyze market and delivery systems in order to minimize supply chain risks
    • Review, update and release SOPs based on continuous improvement programs, ensure all cGMP, Quality Management Systems and Regulatory requirements are followed
    • Provide monthly and quarterly SOX support.
    • Support R&D and new product development through team participation
    • Participate in the development of specifications for equipment, products or substitute materials.
    • Assist in the technical transfer of design/manufacturing specifications for products and/or assemblies to suppliers.
    • Prepare monthly and quarterly metrics. Execute administrative tasks assigned by leadership.

    Minimum requirements

    • Bachelor’s degree from a four-year college or university is highly preferred.
    • 5-8 years of experience in a Buyer or Senior Buyer role.
    • Prior medical device experience preferred.
    • Lean Manufacturing, TCO, Six Sigma or other Continuous Improvement experience preferred
    • Experience with FDA GMP Part 820, CE, UL and ISO 13485 preferred.
    • Highly effective negotiation skills.
    • Working knowledge in contract generation and proficiency in supplier relationship management,
    • Experience with project management, supply chain and material supply processes.
    • ERP experience a plus
    • Strong analytical skills and the ability to interpret and communicate technical specifications
    • Strong work ethic and team player
    • Proficient with writing SOPs and Purchasing documentation
    • Excellent organizational, interpersonal, written and verbal communication skills.
    • Strong computer skills and advanced Microsoft products 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
  • 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
  • Vivarium Technician II

    Research & 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, 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 Vivarium Technician II assists with vivarium operational functions to support all aspects of research within the company. This position conducts vivarium-related compliance training; prepares and performs procedures on a broad spectrum of models; maintains inventory for vivarium; purchases and receives vivarium goods and supplies; and performs other vivarium and administrative duties necessary for the day-to-day operational functions of the vivarium. This position interfaces with multiple departments (R&D, Vivengineering, accounting, quality).

    Essential job functions and duties

    • Under the supervision of the Associate Manager, Vivarium, this position’s logistical support responsibilities include:
    • Prepare, perform, and assist with various in vivo studies.
    • Receive minimal instructions on routine work and detailed instructions on new assignments.
    • Train/oversee Research Associates to ensure safety, ACUP and AAALAC compliance.
    • Oversee/maintain inventory for vivarium supplies.
    • Liaise with vivarium staff regarding concerns and requests.
    • Purchase and receive vivarium inventory.
    • Liaise with vendors to ensure timely purchase, address discrepancies, and obtain quotes.
    • Interface with accounting department to ensure timely purchase order verification and documentation.
    • Conduct safety training for new and current employees.
    • Maintain vivarium equipment.
    • Perform general vivarium duties.
    • Provide support to other members in Logistical group.
    • Prepare documentation and perform recordkeeping responsibilities.
    • Generate reports and write SOPs.
    • Perform other duties as assigned.

    Minimum requirements

    • B.S. degree in biological sciences
    • Minimum 2 years of combined experience working in a vivarium or veterinary setting.
    • Ability to deliver presentations/perform demonstrations to wide audiences.
    • Excellent oral communication/interpersonal skills.
    • Ability to solve complex problems, read and interpret documents, and follow SOPs and protocols.
    • Capable of managing multiple priorities in a fast-paced environment.
    • Works with minimal supervision and a high degree of independence; can also work effectively in a cross-functional team environment.
    • Familiar with basic quality control and quality assurance principles.
    • Willingness and ability to travel locally between worksites.
    • Ability to lift and carry materials weighing up to 35lbs.

    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 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 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 clinical scientist is responsible for overall clinical study conduct of Inovio clinical trials 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.

    Essential job functions and duties

    • Must meet all requirements for Associate Clinical Scientist position and have demonstrated proficiency in all areas
    • Fulfill Clinical Project Lead (CPL) responsibilities, as assigned
    • Author or prepare clinical protocols, informed consent forms, clinical study reports, regulatory documents (e.g., IND, BLA, etc.), and other clinical documents by coordinating input from internal team members and external sources.
    • Develop and manage study timelines and budgets in collaboration with cross functional teams; mitigate challenges that occur
    • 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
    • Lead multidisciplinary Project Teams to ensure trial deliverables are met according to timelines, budget, quality standards and operational best practices
    • Independently manage all components of clinical studies to strategically implement clinical development program(s)
    • Collaborate with strategic sourcing on the development of RFPs and participate in selection of CROs/vendors
    • Establish strong partnerships with external investigators and collaborators and communicate study-related information to investigators and study staff
    • Oversee and track recruitment and retention of study subjects
    • Proactively identify potential operational challenges (e.g., internally/CRO/vendor/investigator) and provide resolution plans and implement solutions to achieve project goals
    • Develop tools and processes that increase efficiencies of the project
    • Plan and participate in conduct of Investigator Meetings
    • Provide protocol and trial specific training at Investigator Meetings and Site Initiation Visits
    • Assist in determining the activities to support a project’s priorities within functional area
    • Train CROs, vendors, investigators, and study coordinators on study requirements, as needed
    • Ensure ongoing activities (e.g., sponsor updates, drug shipments, publications, milestone payments, etc.) for efficient study management and clinical trial execution
    • Manage and oversee vendors for clinical studies
    • Initiate, author, and/or contribute to SOP development, implementation and training
    • Contribute to the development of abstracts, presentations and manuscripts
    • Coordinate the review of data listings and preparation of interim/final clinical study reports
    • Provide knowledge and expertise on country specific regulations, site experience, and suitability for development studies
    • Recruit, hire, manage, mentor, and develop junior staff members (e.g., Associate Clinical Scientist, CTA and/or Clinical Intern), as assigned
    • Serve as the key operational contact with external investigators and internal stakeholders
    • Provide progress updates and summaries to supervisor and/or management
    • Participate in multiple departmental or interdepartmental strategic initiatives under limited supervision
    • Serve as a resource for others within the company for clinical trials management expertise
    • Examine functional issues from and organizational perspective
    • Support inspection readiness and audits as required
    • Participate in vendor and site audits as needed
    • Other tasks may be assigned based on skill sets and business need

    Minimum requirements

    • At least 3+ years of experience and a BS or BA in a relevant scientific discipline
    • Therapeutic Area(s) experience preferred: Infectious Disease, Vaccines, Oncology, or Women's Health.
    • Experience with vaccines highly preferred
    • Regulatory Affairs experience a plus
    • Medical device experience a plus
    • 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
    • Excellent teamwork, communication, decision-making and organizational skills
    • Thorough understanding of FDA regulations, GCP/ICH guidelines, and ISO requirements is required.
    • Up to 20%, primarily domestic

    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 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 Trial Manager

    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

    Responsible for supporting 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. . 

    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 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
  • MD, Associate Director Clinical Development, 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 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
  • 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.