Senior Director, Clinical Pharmacology
About the role
The Clinical Pharmacologist will provide strategic insight and technical leadership within the Clinical Pharmacology function. They will author technical reports and/or regulatory documents for major milestones of clinical development, participate in regulatory interactions and responses to regulatory questions, apply state-of-the-art quantitative modeling, and engage with cross-functional teams.
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.
Requirements
- 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.
Qualifications
- 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.
Skills
- Experience interacting with FDA on dose optimization.
- Hand-on experience with PBPK models.
Benefits
Base Pay Salary Range: $244,000 - $305,000 USD
Schedule
Full-time position for candidates working onsite at our headquarters in Redwood City, CA.
Pay
Base Pay Salary Range: $244,000 - $305,000 USD
Company Information
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. Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com.