Senior Director, Clinical Pharmacology (Redwood City)

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The companys 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 professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The Opportunity:

We are seeking a passionate and experienced Senior Clinical Pharmacologist with strong late development background to be part of the Nonclinical Development and Clinical Pharmacology (NDCP) Organization.

As a key member of the Late Development Clinical Pharmacology group, you will:

Work as a member of the Clinical Study Team (CST).

Independently lead an asset in collaboration with the Product Team Leaders including all technical and strategic decisions and Regulatory Agency negotiations internationally.

Provide strong Clinical Pharmacology support as well as authoring technical reports and/or regulatory documents for major milestones of clinical development, specifically EOP2 meeting and pre-NDA Briefing Documents.

Take responsibility for authoring or overseeing the preparation of submissions documents such as Summary of Biopharmaceutics Studies or Summary of Clinical Pharmacology Studies.

Draft the Clin Pharm components of the USPI or SmPC.

Represent Clin Pharm at Regulatory Agency meetings such as EPO2, Pre-NDA or ODAC meetings if needed.

Required Experience Skills, and Education:

A Ph.D. or Pharm.D (with Fellowship) with Pharmaceutical Sciences background with 10+ years of relevant industry experience in Clinical Pharmacology.

Well-informed in current and emerging standards of regulatory requirements and expectations for pharmacometrics and clinical pharmacology.

Solid knowledge and hands-on experience in Clin Pharm study designs.

Strong understanding of DMPK, CMC and Toxicology and related regulatory guidance is required.

Extensive experience with and defending the companys position at the FDA Type A, Type B, Type C and Type D meetings.

Strong understanding of Project Optimus.

Independent Clin Pharm technical expert and strategist

Well published (20+ publications).

Excellent verbal and written communication skills, and ability to clearly convey complex concepts and findings to both non-specialist and specialist audiences.

A critical thinker and passionate team player and quick learner with high energy who thrives in a dynamic and fast-paced environment.

Preferred Skills:

Prior experience with small molecules in the oncology therapeutic area.

Oncology submissions experience in the US, EU and East Asia.

The base salary range for this full-time position is $236,000 to $295,000 for candidates working onsite at our headquarters in Redwood City, CA. The range displayed on each job posting is intended to be the salary for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our salary ranges are determined by role, level, and location. Individual pay is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.

Please note that base salary is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.

Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.

Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with ourCCPA Notice andPrivacy Policy .For additional information, please [email protected] .

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