VP, Therapeutic Strategy - Oncology

Summary

Join Precision for Medicine as the Vice President, Clinical Development, Oncology, and drive product development across the Precision portfolio, including drugs, biologics, and cell and gene therapies. This role demands a deep understanding of the US Food and Drug Administration Oncology framework and innovative regulatory strategies to accelerate drug development. You will report to the Chief Medical Officer and provide medical and strategic support for business development activities globally. Responsibilities include creating and reviewing protocols, consulting with clients, and ensuring high-quality deliverables. The ideal candidate will have an MD, MBBS, or equivalent, experience with US and/or EU Regulatory Authorities, and a strong background in clinical research.

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

Responsibilities

• Reports to Chief Medical Officer, and across Precision for Medicine, supporting medical strategy
• Provides medical and strategic support for business development activities globally including client engagement, proposal support, client capabilities meetings, and professional meetings
• Provides strategic drug development consulting to oncology and rare and orphan disease clients. The consulting will be provided in the context of an integrated strategy with medical, clinical, regulatory, biostatistical, translational and marketing insights
• Create, review, or revise protocols, case report forms, training materials, project-specific tools, analysis plans, study designs, clinical trial reports, and investigational new drug applications
• Review laboratory values, adverse events, coding dictionaries and data tables, listings and figures as needed
• Participate and drive feasibility discussions relating to specific project proposals
• Develop training modules and conducts training for project teams and colleagues as necessary
• Ensure high quality, data driven deliverables that meet the highest standards of medical, ethical, and scientific integrity and conduct
• Propose strategies to manage and accelerate timelines for drug development strategies
• Ensures customer satisfaction by working closely with senior management, PFM operations, to provide optimum strategic consultancy to clients

Preferred Qualifications

• 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