Revolution Medicines is seeking to develop novel targeted therapies to inhibit frontier targets in RAS-addicted cancers and is looking for a Clinical Pharmacologist to join their Nonclinical Development and Clinical Pharmacology Organization to contribute to the clinical pipeline delivery
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
- Prior experience with small molecules in oncology drug development
- Proven successful industry experience in oncology submissions in the US, EU and Asia
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 population PK, exposure-response analyses, 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, CSR, IB, briefing package, SCP/SBS, label ) 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
- Ability to manage internship and fellowship programs
Other
- A Ph.D. or PharmD or equivalence 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
- RevMed's guideline for Director level with doctorate degree is 11+ years
