Director, Pharmacometrics bei 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.

The Opportunity:

We are seeking a passionate and experienced pharmacometrician with strong PBPK modeling background to be part of the Nonclinical Development and Clinical Pharmacology (NDCP) Organization. 

As a key member of the pharmacometrics group, you will:

• Provide strong PBPK support as well as author technical reports and/or regulatory documents for major milestones of clinical development (EOP1/EOP2/NDA/sNDA).

• Lead the efforts of building internal PBPK workflow with FDA compliance and preparing submission-ready package.

• Work closely with DMPK and PDM colleagues to refine and validate PBPK models.

• Engage and work with consultants and/or CROs on pharmacometrics activities that complement in-house capabilities.

• Represent the pharmacometrics function in project teams and build strong working relationships with cross-functional teams.

Required Skills, Experience and Education:

• A Ph.D.  with 8+ years of relevant industry experience in PBPK.

• Ability to manage/ mentor junior members in the PBPK field.

• Solid knowledge about whole-body PBPK and hands-on experience in building PBPK models using SimCYP and PK-sim.

• Demonstrated experience and track record of using PBPK to support regulatory submissions (DDI, Special populations, etc.) and to address comments from regulatory agencies.

• Well-informed in current and emerging standards of regulatory requirements and expectations for pharmacometrics and clinical pharmacology.

• Able to take dynamically assigned pharmacometrics tasks and deliver the results in a timely manner.

• 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.

Preferred Skills:

• Prior experience with NDA/sNDA.

• Prior experience with small molecules in the oncology space.

• Proficiency in QSP and/or R programming. #LI-Hybrid #LI-CT1