Executive Director, Head of Late Development, Clinical Pharmacology at 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:

As the Executive Director, reporting to the head of Clinical Pharmacology, you will shape and scale the Late Development team of Clin Pharm and make a deep impact to our oncology pipeline by driving critical decisions across our Late Development portfolio. Specifically, you will:

• Serve as a trusted advisor to project teams and governance committees and act as a thought partner to impact cross-functional development strategies.

• Oversee all Clin Pharm activities after a successful EOP2 meeting with the FDA. This will include working closely with the PTLs and Clinical Leads to plan the pivotal study, overseeing design and execution of all Clin Pharm studies needed for a successful NDA.

• Partnering with the Head of Early Development team in planning for coverage of programs making the transfer to Late Development.

• Oversee completion of all MIDD activities such as PBPK modelling in support of a successful NDA.

• Oversee the implementation of efficient modeling and simulation strategy, including population PK, exposure-response analysis, and physiologically based PK (PBPK) to support clinical trial design, justification of dosing regimen, and provide supportive evidence of efficacy and safety for regulatory submissions.

• Oversee authoring of relevant sections/modules of regulatory documents (including INDs, IBs, CTAs, IMPDs, NDAs, briefing packages, or other regulatory dossier) and participate in interactions with regulatory authorities.

• Collaboration with executive level management on critical matters such as influencing policymaking.

• Lead and oversee departmental systems/processes and “best practices” for effective delivery and ensure internal team stays current with relevant regulatory guidelines for compliance.

• Drive and foster innovation and adoption of emerging technologies and approaches to drive critical Clin Pharm deliverables.

• Lead short- and long-range planning, annual budgeting and reforecasting activities for Clinical Pharmacology and Pharmacometrics. Monitor and manage budgets for the function.

• Build and scale the Late Development Clin Pharm group to meet the expectations of the organization.

• Drive and lead staff management strategies and processes focused on scalable growth, effective organizational design, employee engagement and performance optimization; provide ongoing feedback and coaching to support professional development while aligning individual aspirations and business objectives.

Required Skills, Experience and Education:

• D. in relevant fields or equivalent training with 15+ years progressive industry experience in clinical pharmacology, pharmacometrics, or related technical areas.

• Deep knowledge in clinical pharmacology, broad translational and clinical development experience with track records in building and leading a high-performing Clinical Pharmacology and Pharmacometrics teams that drive strategic outcomes in support of oncology drug development.

• Significant experience with oncology submissions in the US, EU and Asia.

• Significant experience with development of overall Clin Pharm strategy and operational management of plans with cross-functional teams.

• Proven performance in comparable role including strategic oversight and stakeholder management across levels internally and externally.

• Innovative attitude coupled with a strong sense of practical execution.

• Well-informed in current and emerging scientific standards of regulatory requirements and expectations.

• 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, ability to work collaboratively with cross-functional leadership team 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.

Preferred Skills:

• Proven successful industry experience in oncology submissions in the US, EU and Asia. #LI-Hybrid  #LI-GL1