Associate Director, Clinical Pharmacology

Revolution Medicines

2d • Remote

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 early development background to be part of the Nonclinical Development and Clinical Pharmacology (NDCP) Organization.
As a member of the Early Development Clinical Pharmacology group, you will:
Provide strategic insight and technical leadership within the Clinical Pharmacology function.
Author technical reports and/or regulatory documents for major milestones of clinical development, specifically IND, EOP1 & EOP2 Briefing Documents. 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 Discovery organization to support assets in the IND-enabling stage, including collaboration with DMPK and Toxicology groups in assessment of human start dose and assessment of the need for human DDI studies.
Work with the Clinical Development team in designing FIH study.
Design and report Clin Pharm studies such as hADME, Food-Effect and DDI studies.
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.

Requirements

• A Ph.D. or Pharm.D (with Fellowship) with Pharmaceutical Sciences background with 5+ years of relevant 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.
• Hands-on experience with WinNonlin and Clin Pharm study designs.
• Strong understanding of DMPK, CMC and Toxicology and related regulatory guidance is required.
• 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.
• Prior management experience.

Nice To Haves

• Prior experience interacting with FDA on dose optimization.
• Hand-on experience with PBPK models.

Responsibilities

• Provide strategic insight and technical leadership within the Clinical Pharmacology function.
• Author technical reports and/or regulatory documents for major milestones of clinical development, specifically IND, EOP1 & EOP2 Briefing Documents. 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 Discovery organization to support assets in the IND-enabling stage, including collaboration with DMPK and Toxicology groups in assessment of human start dose and assessment of the need for human DDI studies.
• Work with the Clinical Development team in designing FIH study.
• Design and report Clin Pharm studies such as hADME, Food-Effect and DDI studies.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree