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 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
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%,
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, gender identity and expression, religion, marital status, registered domestic partner status, age, national origin or ancestry, military or 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.
Important notice to employment businesses/agencies
Inovio does not accept referrals from employment agencies unless written authorization from the Inovio Human Resources department has been provided. In the absence of written authorization, any actions undertaken by employment agencies shall be deemed to have been performed without our consent and therefore Inovio will not be liable for any fees arising from employment agency referrals in respect to current or future position vacancies at Inovio.
