Associate Director, Clinical Pharmacology

Revolution Medicines•Redwood City, CA

4d•Hybrid

About The Position

Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. 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 highly motivated and energetic individual with a relevant scientific background to be part of the Nonclinical Development and Clinical Pharmacology (NDCP) Organization. As a key member of Clinical Pharmacology group, you will: Represent the clinical pharmacology function in project teams and build strong working relationships with cross-functional teams to impact critical decisions. Responsible for clinical pipeline delivery through major milestones including IND/CTA, EOP2, and marketing applications NDA/sNDA. Lead the design and execution of an integrated clinical pharmacology and modeling and simulation strategy to guide the clinical development plan. Apply state-of-the-art quantitative pharmacology analyses, including population PK, exposure-response analyses, to guide dose/schedule selection and recommended phase 2 dose and schedule (RP2Ds) selection. 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) and responses to regulatory questions. Engage and work with consultants and/or CROs on clinical pharmacology activities to complement in-house knowledge/expertise and capacities. Ability to manage internship and fellowship programs.

Requirements

A Ph.D. or Pharm.D or equivalence with 4+ years of relevant industry experience in Clinical and Quantitative 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 models.
Track record of applying modeling and simulation methodologies to inform and accelerate drug development.
Well-informed in current and emerging scientific standards of regulatory requirements and expectations.
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 with high energy who thrives in a dynamic and fast-paced environment.

Nice To Haves

Prior experience with small molecules in oncology drug development.
Proven successful industry experience in oncology submissions in the US, EU and Asia.

Responsibilities

Represent the clinical pharmacology function in project teams and build strong working relationships with cross-functional teams to impact critical decisions.
Responsible for clinical pipeline delivery through major milestones including IND/CTA, EOP2, and marketing applications NDA/sNDA.
Lead the design and execution of an integrated clinical pharmacology and modeling and simulation strategy to guide the clinical development plan.
Apply state-of-the-art quantitative pharmacology analyses, including population PK, exposure-response analyses, to guide dose/schedule selection and recommended phase 2 dose and schedule (RP2Ds) selection.
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) and responses to regulatory questions.
Engage and work with consultants and/or CROs on clinical pharmacology activities to complement in-house knowledge/expertise and capacities.
Ability to manage internship and fellowship programs.