Vice President, Clinical Development

Precision is seeking an experienced and passionate regulatory physician to join our team as Vice President, Clinical Development. The ideal candidate will have a deep understanding of the US Food and Drug Administration framework, and innovative regulatory strategies to accelerate drug development.

Requirements

• 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 autoimmune, or oncology depending on specialty, and rare and orphan disease clients.
• 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.

Benefits

• Discretionary annual bonus
• Health insurance
• Retirement savings benefits
• Life insurance
• Disability benefits
• Parental leave
• Paid time off for sick leave and vacation