Associate Director, Clinical Pharmacology

Role Summary

Associate Director, Clinical Pharmacology at Revolution Medicines, a clinical-stage precision oncology company focused on novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. You will be part of the Nonclinical Development and Clinical Pharmacology (NDCP) Organization, contributing to the clinical pharmacology strategy and execution in support of the company’s RAS pathway programs.

Responsibilities

• Represent the clinical pharmacology function in project teams and build strong working relationships with cross-functional teams to impact critical decisions.
• Responsible for clinical pipeline delivery through major milestones including marketing applications NDA/sNDA and EOP2.
• Lead the design and execution of an integrated clinical pharmacology and modeling and simulation strategy to guide the clinical development plan.
• Apply state-of-the-art quantitative pharmacology analyses, including PBPK, translational PK/PD, population PK, exposure-response analyses, and system pharmacology, to guide dose/schedule selection and recommended phase 2 dose and schedule (RP2Ds) selection.
• Author and provide technical input for regulatory documents and submissions related to all aspects of clinical pharmacology (including protocol, IB, briefing package, etc) and responses to regulatory questions.
• Engage and work with consultants and/or CROs on clinical pharmacology activities to complement in-house knowledge/expertise and capacities.

Qualifications

• Required: A Ph.D. with 5+ years of relevant industry experience in Clinical and Quantitative pharmacology.
• Required: Expertise in clinical pharmacology, hands-on modeling, and simulation skills using NONMEM, R and/or other modeling and simulation software. Experience with population PK, Exposure-Response, and advanced mechanistic PK/PD models.
• Required: Prior experience with authoring regulatory documents such as IND/CTA, EOP2, and marketing applications NDA/sNDA.
• Required: Prior experience with small molecules in oncology drug development.
• Required: Well-informed in current and emerging scientific standards of regulatory requirements and expectations.
• Required: Excellent verbal and written communication skills, and ability to clearly convey complex concepts and findings to both non-specialist and specialist audiences.
• Required: Strong interpersonal skills, and ability to influence development project and management teams.
• Required: A critical thinker and passionate team player with high energy who thrives in a dynamic and fast-paced environment.
• Preferred: Track record of applying modeling and simulation methodologies to inform and accelerate drug development.
• Preferred: Hands-on experience with PBPK models using SimCYP, GastroPlus and PK-sim.
• Preferred: Experience with late clinical development in oncology.