Revolution Medicines is seeking to solve the business problem of developing novel targeted therapies for RAS-addicted cancers by hiring a Clinical Pharmacologist to lead the design and execution of clinical pharmacology and modeling strategies to guide drug development.
Requirements
- 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.
- Track record of applying modeling and simulation methodologies to inform and accelerate drug development.
- Well-informed in current and emerging scientific standards of regulatory requirements and expectations.
- Hand-on experience with PBPK models using SimCYP and PK-sim.
- Prior experience with small molecules in oncology drug development.
- Prior experience with authoring regulatory documents such as IND/CTA, EOP2, and marketing applications NDA/sNDA.
Responsibilities
- Responsible for clinical pipeline delivery through major milestones including IND/CTA, EOP2, and marketing applications NDA/sNDA.
- 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.
- Represent the clinical pharmacology function in project teams and build strong working relationships with cross-functional teams to impact critical decisions.
Other
- A Ph.D. or Pharm.D. with 8+ years of relevant industry experience in Clinical and Quantitative pharmacology.
- Excellent verbal and written communication skills, and ability to clearly convey complex concepts and findings to both non-specialist and specialist audiences.
- Strong interpersonal skills, and ability to influence development project and management teams.
- A critical thinker and passionate team player with high energy who thrives in a dynamic and fast-paced environment.
- LI-Hybrid
