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Job Description
Precision for Medicine is seeking a VP, Therapeutic Strategy – Oncology. This role involves driving product development across the Precision portfolio, including drugs, biologics, and cell and gene therapies for oncology and rare disease. The role will focus on regulatory strategy and clinical development, for early to late phase trials. The VP will report to the Chief Medical Officer and support medical strategy across Precision for Medicine.
Role involves:
- Providing medical and strategic support for business development activities globally.
- Providing strategic drug development consulting to oncology and rare and orphan disease clients.
- Creating, reviewing, or revising protocols, case report forms, training materials, project-specific tools, analysis plans, study designs, clinical trial reports, and investigational new drug applications.
- Participating and driving feasibility discussions relating to specific project proposals.
- Developing training modules and conducts training for project teams and colleagues as necessary.
Requirements:
- Successful completion of MD, MBBS, or equivalent training plus completion of training including a fellowship (Hematology-Oncology preferred; board certification preferred, including European equivalents)
- Experience in direct interactions with US and/or EU Regulatory Authorities
- At least 10 years of demonstrated knowledge and experience in the clinical research industry with substantial experience including related disciplines (i.e. operations, medical monitoring, biostatistics, regulatory, preclinical, translational pharmacology, etc.)
- Clinical experience with previous exposure to regulatory and statistical activities such as (co) authoring and reviewing of documents such as clinical trial protocols, statistical analysis plans, IND, NDA, PSUR, DSUR, IB, ICF, Breakthrough Designation, and regulatory briefing documents
- Working knowledge of the safety reporting process globally
- The ability to travel domestically and/or internationally for Client and/or Health Authority Meetings and Thought Leadership/Conference Attendance
