Manager, Clinical Pharmacology

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 Revolutionariesin 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:

• 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.

Required Skills Experience and Education:

• 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 FDAs 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.

Preferred Skills:

• Prior experience in NDA submission.

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