13 days ago
My client is a global clinical stage biopharmceutical company that foucses in developing small molecule therapies for cancers and hepatitis B. With 8 compounds in clinical stage development, they are seeking a VP of Clinical Development to become a leader within the company, and lead clinical development responsibilties for the ongoig trials.
Responsibilities require but are not limited to:
- Development of protocols for clinical studies
- Draft clinical scientific documents (IND amendments Investigator Brochures, Annual Reports, Clinical Study reports, safety update reports and other FDA submissions, Risks / benefits analysis for applicable documents
- Assist with study design
- Partner with clinical ops and other functional areas for the successful implementation and execution of clinical studies.
- Provide scientific expertise for selection of investigator and vendors.
- Assist with study design for exploratory development
- Interpret clinical data
- A medical degree (M.D./Ph.D. or equivalent) with significant scientific research experience required
- 10+ years of experience in clinical research (including medical affairs) with at least
- 5 or more years of drug development experience within other biotech / pharmaceutical companies are required