Manager, Clinical Pharmacology
About The Position
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 a passionate and experienced Clinical Pharmacologist with strong background to be part of the Nonclinical Development and Clinical Pharmacology (NDCP) Organization. As a member of the Late Development Clinical Pharmacology group, you will:
Requirements
- A Ph.D. or Pharm.D (with Fellowship) with Pharmaceutical Sciences or related disciplines is required with 0-2 years of relevant industry experience in Clinical Pharmacology.
- Prior experience with small molecules oncology drug development.
- Familiar with FDA’s Project Optimus guidance.
- Well-informed in current and emerging standards of regulatory requirements and expectations for clinical pharmacology.
- Expertise in clinical pharmacology, hands-on modeling, and simulation skills using NONMEM, R, and/or other modeling and simulation software.
- Experience with population PK, exposure-response, and advanced mechanistic PK/PD.
- 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.
Nice To Haves
- Prior experience in NDA submission.
Responsibilities
- Provide strategic insight and technical leadership within the Clinical Pharmacology function.
- Author and provide technical input for regulatory documents and submissions related to all aspects of clinical pharmacology (including protocol, CSR, IB, briefing package, SCP/SBS, label etc).
- Participate in regulatory interactions and responses to regulatory questions.
- Apply state-of-the-art quantitative modeling, including translational PK/PD, population PK, and exposure-response analyses, to guide recommended phase 2 dose/schedule (RP2Ds) selection for pivotal studies.
- Work with the Clinical Development team in designing pivotal Phase 3 study.
- Engage and work with CROs on clinical pharmacology activities.
- Represent the Clinical Pharmacology function in project teams and build strong working relationships with cross-functional teams to impact critical decisions.
- Manage internship and fellowship programs.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Education Level
Ph.D. or professional degree
