5h ago
Medical Director
Redwood City, California, United States
full-timeseniorbiotechnology
Description
You will serve as Medical Director supporting clinical-stage molecules, ensuring data integrity and regulatory submission readiness for novel RAS-targeted oncology therapies. You'll lead clinical science aspects of development plans and collaborate cross-functionally to drive successful global filings.
Requirements
- M.D. or equivalent degree
- Oncology experience
- Proven expertise in clinical trial data review, cleaning, and regulatory submission preparation
- Experience with FDA, EMA, and ICH standards for NDA/BLA/MAA filings
- Strong leadership and cross-functional collaboration skills
Responsibilities
- Serve as clinical point of accountability for data integrity in oncology studies
- Lead clinical science aspects of clinical development strategy and documentation
- Partner with Regulatory Affairs, Biostatistics, and Data Management for regulatory submissions
- Drive end-to-end data cleaning strategy and reconciliation of safety/efficacy data
- Lead, mentor, and contribute to cross-functional clinical development teams
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