Senior Medical Director - Late Stage

Minimum 13+ years’ experience in clinical development required (Pharma R&D experience outside of a clinical development role also considered pending transferability of skills and responsibilities).

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.

Extensive experience working with the principles and techniques of data analysis, interpretation, and clinical relevance as related to the pharmaceutical/biotech industry.

We are seeking an experienced clinical science drug developer to serve as Senior Medical Director in support of Revolution Medicines’ clinical-stage molecule(s).

In this critical role, you will support various clinical science deliverables and enable effective and efficient execution of the clinical development plan for a molecule(s) within its particular indication(s).

The physician-scientist will focus on ensuring the accuracy, completeness, and integrity of clinical data supporting regulatory submissions (NDA, BLA, MAA).

This role is uniquely positioned at the interface of clinical development, regulatory science, clinical data, and clinical operations, and will be instrumental in preparing pivotal datasets from the pivotal and supportive studies for successful global filings.

or equivalent), oncology experience, and proven expertise in clinical trial data review, cleaning, and regulatory submission preparation.

The scope of data review and support activities spans early-stage clinical research to pivotal studies including regulatory submissions.