Description

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 Clinical Scientist is responsible for overall clinical study oversight of Inovio and investigator sponsored research to ensure accurate and complete data and compliance with protocol(s) and Federal regulations, ICH, and GCPs, and local requirements. This position brokers relationships with of external consultants and oversight of clinical trial operations as performed by a CRO and other external consultants.

Essential Job Functions And Duties

• Must meet all requirements for the Clinical Scientist 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.), 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
• 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 and track recruitment and retention of study subjects
• Communicate with functional peers regarding project status and issues and ensure protect team goals are met
• Establish strong partnerships with external investigators and collaborators and communicate study-related information to investigators and study staff
• Proactively identify potential operational challenges (e.g., internally/CRO/vendor/investigator) and provide resolution plans and implement solutions to achieve project goals
• Resolve problems using national and international regulations, guidelines, and investigator interaction
• Collaborate with strategic sourcing on the development of RFPs and participate in selection of CROs/vendors
• Train CROs, vendors, investigators and study coordinators on study requirements
• Develop tools and processes that increase efficiencies of the project
• Manage and oversee vendors for clinical studies
• Plan and participate in conduct of Investigator Meetings
• Provide protocol and trial specific training at Investigator Meetings and Site Initiation Visits
• Ensure ongoing activities (e.g., sponsor updates, drug shipments, publications, milestone payments, etc.) for efficient study management and clinical trial execution
• Ensure high quality internal Clinical Operations databases and document repositories
• 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, manage, mentor, and develop junior staff members (e.g., Clinical Scientist, CTA), as assigned
• Contribute to development of abstracts, presentations, and manuscripts
• Provide knowledge and expertise on country specific regulations, offer strategic input for study delivery
• Provide progress updates and summaries to supervisor and/or management
• Support management in multiple departmental or interdepartmental strategic initiatives
• Examine functional issues from a broader 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

• Bachelor's degree required plus 5 years of clinical research experience, including vendor management or Advanced degree plus 3 years of clinical research experience, including vendor management
• Therapeutic Area(s) experience preferred: Infectious Disease, Vaccines, Pediatric, or Oncology,
• Experience with vaccines highly preferred
• Regulatory Affairs experience a plus
• Medical device experience a plus
• MS Office Suite proficiency (Word, Outlook)
• Experience in protocol development, study implementation, study management, monitoring, and study report preparation is required
• Excellent oral and written communication skills, attention to detail and ability to interact effectively with management and prioritize diverse projects for multiple disciplines
• Ability to multi-task and interact with multiple levels in a growing, fast paced organization
• 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.