Senior Medical Director

Overview

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The Opportunity:

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.

The ideal candidate brings a strong foundation in clinical medicine (M.D. 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. You will play a vital role in leading the clinical science aspects of the Clinical Development Plan (CDP) strategy, driving the development of transformative therapies for patients.

Furthermore:

• Serve as the clinical point of accountability for data integrity in ongoing and completed studies across the oncology portfolio.

• Apply medical expertise to guide query resolution, adjudication of outliers, and clinical plausibility review during data cleaning.

• Collaborate with clinical study teams to align protocol design, CRFs, and data standards with downstream regulatory submission requirements.

• Lead clinical science aspects of the clinical development strategy and clinical documentation.

• Represent the clinical development plan on appropriate teams, sub-teams and forums; oversee training of study site personnel, act as primary point-of-contact for questions/enquires regarding the CDP at a program level, oversee the conduct of medical/safety data reviews and study reporting.

• Partner with Regulatory Affairs, Biostatistics, Data Management, and Medical Writing to ensure clinical datasets, narratives, and summaries meet FDA, EMA, and ICH standards for NDA/BLA/MAA filings.

• Support the Medical Monitors Medical Lead and other team leads in clinical sections of regulatory dossiers, including Integrated Summary of Efficacy (ISE), Integrated Summary of Safety (ISS), and Clinical Study Reports (CSRs).

• Support in the preparation of responses to regulatory authorities and contribute to advisory committee briefing documents.

• Drive end-to-end data cleaning strategy, ensuring timely resolution of queries and reconciliation of safety, efficacy, and laboratory data.

• Lead clinical data review meetings, escalating issues and recommending solutions to maintain data reliability and consistency.

• Potential assignment to complex and high-priority strategic studies for Revolution Medicines’ molecules, with expectation to perform responsibilities with independence and clear self-directed leadership.

• Work closely with Data Management, Medical Monitors, CRO, Clinical Operations to ensure that site-level data collection, query resolution and other activities align with submission requirements.

• Partner with Rev Med’s Pharmacovigilance to reconcile safety databases with clinical trial datasets.

• Cross-functionally align efforts seamlessly with scientific, regulatory, and commercial objects while executing upon the clinical development plan.

• Lead,…