Vice President, Head of Late Development, Clinical Pharmacology

Revolution Medicines • Redwood City, CA

71d • $284,000 - $355,000

About The Position

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. As the Vice President, reporting to the Head of Clinical Pharmacology & Pharmacometrics, 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.

Requirements

• Ph.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 team 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.

Nice To Haves

• Proven successful industry experience in oncology submissions in the US, EU and Asia.

Responsibilities

• 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, including working closely with the PTLs and Clinical Leads to plan the pivotal study.
• Partner 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.
• Oversee authoring of relevant sections/modules of regulatory documents and participate in interactions with regulatory authorities.
• Collaborate 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 Late Development Clinical Pharmacology team.
• Be the Clinical Pharmacology organization's representative on Protocol Review Committee (PARC).
• Participate in Business Development activities such as Due Diligence work.
• 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.

Benefits

• Competitive cash compensation
• Robust equity awards
• Strong benefits
• Significant learning and development opportunities

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Industry: Chemical Manufacturing
• Education Level: Ph.D. or professional degree
• Number of Employees: 501-1,000 employees