Clinical Program Manager at Inovio in Plymouth Meeting, Pennsylvania

Job Description:

INOVIO is a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines to potentially treat and protect people from diseases associated with HPV, cancer, and infectious diseases. INOVIO is the first and only company to have clinically demonstrated that a DNA medicine can be delivered directly into cells in the body via a proprietary smart device to produce a robust and tolerable immune response. Partners and collaborators include Advaccine, ApolloBio Corporation, AstraZeneca, The Bill & Melinda Gates Foundation, Coalition for Epidemic Preparedness Innovations (CEPI), Defense Advanced Research Projects Agency (DARPA)/Department of Defense (DOD), GeneOne Life Science/VGXI, HIV Vaccines Trial Network, International Vaccine Institute (IVI), Medical CBRN Defense Consortium (MCDC), National Cancer Institute, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Ology Bioservices, Plumbline Life Sciences, Regeneron, Richter-Helm, Roche/Genentech, University of Pennsylvania, Walter Reed Army Institute of Research, and The Wistar Institute. For more information, visit .
Notice to Applicants: Inovio is seeking to fill one available position in our Clinical Trial group. Below are postings for two different levels and candidates meeting the qualifications for either of these positions will be considered. The successful candidate will be hired with a title and salary commensurate with education and experience.
POSITION #1: Clinical Program Manager
Job summary
The Clinical Program Manager is responsible for management of clinical studies managed or sponsored by Inovio to ensure accurate and complete data and compliance with protocol(s) and Federal Regulations, ICH, GCP, and local requirements. This position oversees clinical trial operations internally, and as performed by a CRO, vendor, and external consultants.
Essential job functions and duties
- Fulfill Clinical Project Lead (CPL) responsibilities, as assigned
- Author or prepare clinical protocols, informed consent forms, clinical study reports, Clinical aspects of regulatory documents (e.g., IND, BLA, etc.), and other clinical documents by coordinating input from internal team members and external sources.
- Implement trials, including CRO selection, selection and qualification of clinical investigators and conduct of pre study visits as needed
- Ensure adequate timeline management, investigator communication, monitoring oversight, and financial health of study
- Manage and oversee vendors for clinical studies including review of monitoring reports and site correspondence
- Collaborate with strategic sourcing on the development of RFPs and participate in selection of CROs/vendors
- Develop and manage study timelines and budgets in collaboration with cross functional teams; mitigate challenges that occur
- Independently manage all components of complex studies, compassionate use programs, and non-interventional studies
- Ensure compliance 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)
- Oversee recruitment and retention of study subjects
- Communicate with functional peers regarding project status and issues to ensure project team goals are met
- Proactively identify potential operational challenges (e.g., internally/CRO/vendor/investigator) and provide resolution plans and implement solutions to achieve project goals
- Contribute to development of abstracts, presentations, and manuscripts
- 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
- Establish strong partnerships with external investigators and collaborators and communicate study-related information to investigators and study staff
- Ensure ongoing activities (e.g., sponsor updates, drug shipments, publications, milestone payments, etc.) for efficient study management and clinical trial execution
- Manage the review of data listings and preparation of interim/final clinical study reports
- Initiate, author, and/or contribute to SOP development, implementation and training
- Recruit, hire, mentor and manage Sr. Clinical Scientist (CS), CS, Associate, CS, and Clinical Trials Associate
- Manage, mentor, and develop junior staff members (e.g., Clinical Scientist, CTA), as assigned
- Provide knowledge and expertise on country specific regulations, site experience and suitability for development studies
- Provide progress updates and summaries to supervisor and/or management
- Support management with implementation of departmental strategies and policies
- 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
- Bachelor/Master's degree plus 7 years of experience in a relevant scientific discipline
- Therapeutic Area(s) experience preferred: Infectious Disease, Vaccines, Oncology, or Women's Health.
- Experience with vaccines highly preferred
- Certified in clinical research preferred
- MS Office Suite proficiency (Word, Outlook)
- Experience in protocol development, study implementation, study management, monitoring, and study report preparation is required
- Excellent oral and technical/medical writing capability is required
- Attention to detail and ability to interact effectively with management and prioritize diverse projects for multiple disciplines
- Thorough understanding of FDA regulations, GCP/ICH guidelines, and ISO requirements is required.
POSITION #2: Senior Clinical Program Manager
Job summary
The Senior Clinical Program Manager is responsible for management of clinical studies managed or sponsored by Inovio to ensure accurate and complete data and compliance with protocol(s) and Federal Regulations, ICH, GCP, and local requirements. This position oversees clinical trial operations internally, and as performed by a CRO, vendor, and external consultants.
Essential job functions and duties
- Must meet all requirements for Clinical Project Manager position and have demonstrated proficiency in all relevant 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.

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