[Hiring] Senior Director, Clinical Pharmacology @Revolution Medicines

Role Description

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.

Qualifications

• A Ph.D. or Pharm.D (with Fellowship) with Pharmaceutical Sciences background with 8-10 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 Skills

• 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.

Base Pay Salary Range

$232,000 — $290,000 USD