Senior Medical Director, Late Phase Development
$346,000–$397,000 year
On-site · Redwood City, California, United States
Job Summary
Senior Medical Director, Late Phase Development at Revolution Medicines who will own clinical data integrity across oncology studies, guide regulatory submissions (NDA/BLA/MAA), lead cross-functional clinical development activities, and drive strategy and execution for late-stage programs. Responsibilities include ruling on data cleaning and queries, aligning protocol design and CRFs with regulatory requirements, preparing regulatory documents and responses, mentoring teams, and collaborating with Regulatory Affairs, Biostatistics, Data Management, Medical Writing, and Pharmacovigilance to ensure FDA/EMA/ICH standards are met. Requires MD/MBBS/MBChB with Oncology/Hematology board eligibility, 13+ years in clinical development, 5+ years in late-stage development, and extensive experience in data review for NDA/BLA filings; capability to lead regulatory interactions and strategic development efforts.
Required Qualifications
- M.D. (or equivalent international medical degree, MBBS, MBChB) with board certification/eligibility in Oncology or Hematology-Oncology; subspecialty training in GI malignancies strongly preferred
- Minimum 13+ years’ experience in clinical development
- Minimum 5 years of experience in late-stage clinical development within the biotech/pharmaceutical industry
- Demonstrated experience with medical data review, cleaning for NDA or BLA filings and regulatory submissions
- Strong working knowledge of data cleaning, database lock processes, and clinical data review
- Proven ability to lead cross-functional clinical teams and contribute to strategic development plans
- Excellent written and verbal communication skills for scientific and regulatory audiences
- Extensive experience with data analysis, interpretation, and clinical relevance in pharma/biotech
- Experience in protocol writing/ICF and CRF coordination
- Therapeutic area expertise and relevant regulatory trial experience
- Strong knowledge of GCP, ICH, FDA, EMA guidelines
- Experience authoring regulatory briefing packs and responses to Health Authority questions
- Leadership in study design, feasibility, timelines/budget projections
- Experience engaging external investigators and KOLs
- Strong teamwork, leadership, mentoring abilities
- Capability to drive clinical development strategy for regulatory submissions
- Ability to interact with Health Authorities and major reference health authorities
- Demonstrated adaptability and strategic thinking
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