Director, Clinical Pharmacology jobs in United States
cer-icon
Apply on Employer Site
company-logo

Revolution Medicines · 11 hours ago

Director, Clinical Pharmacology

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies for RAS-addicted cancers. The role involves providing strategic insight and technical leadership in Clinical Pharmacology, including authoring regulatory documents and engaging with cross-functional teams to guide clinical development efforts.

Health CareLife ScienceMedical
check
H1B Sponsor Likelynote

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

Qualification

Ph.D.Pharm.DClinical PharmacologyOncology drug developmentFDA Project OptimusWinNonlinDMPK understandingRegulatory guidanceManagement experienceCommunication skillsCritical thinkingTeam player

Required

A Ph.D. or Pharm.D (with Fellowship) with Pharmaceutical Sciences background with 8+ 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
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

Preferred

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

Benefits

Competitive cash compensation
Robust equity awards
Strong benefits
Significant learning and development opportunities

Company

Revolution Medicines

twittertwitter
company-logo
Revolution Medicines is an innovative and dynamic organization of expert biologists, chemists, pharmacologists, clinical scientists.

H1B Sponsorship

Revolution Medicines has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (13)
2024 (18)
2023 (15)
2022 (8)
2021 (1)
2020 (2)

Funding

Current Stage
Public Company
Total Funding
$2.25B
Key Investors
Royalty PharmaBoxer CapitalNextech Invest
2025-06-24Post Ipo Debt· $250M
2024-12-02Post Ipo Equity· $750M
2023-03-02Post Ipo Equity· $323.6M

Leadership Team

leader-logo
Luan Wilfong
Chief Human Resources Officer
linkedin
leader-logo
Steve Kelsey
President
linkedin
Company data provided by crunchbase