Senior Medical Director - Late Stage
Revolution Medicines
Revolution Medicines seeks a Senior Medical Director to lead clinical development of oncology molecules targeting RAS-addicted cancers. The role focuses on ensuring data integrity, regulatory compliance, and successful preparation of clinical datasets for global regulatory submissions.
Responsibilities
- Oversee data integrity and accuracy for ongoing and completed oncology studies
- Guide query resolution, outlier adjudication, and clinical plausibility during data cleaning
- Collaborate with clinical teams on protocol design alignment with regulatory requirements
- Partner with regulatory affairs, biostatistics, and medical writing on submission documentation
- Lead clinical data review meetings and escalate issues requiring resolution
Requirements
- M.D. or equivalent medical degree
- Oncology clinical development experience
- Expertise in clinical trial data review, cleaning, and validation
- Experience preparing regulatory submissions (NDA, BLA, MAA)
- Strong knowledge of FDA, EMA, and ICH regulatory standards
- Demonstrated leadership in cross-functional clinical teams
Vacancy posted 6 days ago
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