Director, Clinical Pharmacology

Overview

Join to apply for the Director, Clinical Pharmacology role at Revolution Medicines
.

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.

• Provide strategic insight and technical leadership within the Clinical Pharmacology function.
• Author technical reports and 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 (RP2
  
  Ds) selection for pivotal studies.
• Collaborate with the Discovery organization to support assets in IND-enabling stages, including collaboration with DMPK and Toxicology groups in assessment of human start dose and need for human DDI studies.
• Work with the Clinical Development team in designing FIH studies.
• Design and report Clinical Pharmacology 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.

• A Ph.D. or Pharm.
  
  D (with Fellowship) in Pharmaceutical Sciences with 8+ years of relevant industry experience in Clinical Pharmacology.
• Prior experience with small molecule 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 Win Nonlin and Clin Pharm study designs.
• Strong understanding of DMPK, CMC and Toxicology and related regulatory guidance.
• Excellent verbal and written communication skills, and ability to convey complex concepts to both non-specialist and specialist audiences.
• Critical thinker, task-focused team player, quick learner with high energy in a dynamic, fast-paced environment.
• Prior management experience.

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

The base pay salary range for this full-time position for onsite employees in Redwood City, CA is $204,000 — $255,000 USD. The range is base pay and may be adjusted for the local market. Individual base pay is determined by role, level, location, skills, experience, and education or training. This range is one part of the overall total rewards program, which includes competitive cash compensation, equity awards, benefits, and learning 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.

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Base Pay Salary Range
$204,000 — $255,000 USD

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