Senior Director, Global Regulatory Affairs Project Management

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:

The Senior Director of Global Regulatory Affairs Project Management will build and lead the Regulatory Project Management function at RevMed. They will provide cross-functional leadership of planned and ongoing global marketing applications to enable cross-functional coordination and execution across RevMed programs. They will work in concert with the Global Registration Leads and Global Regulatory Study Leads to provide targeted & actionable guidance across the development organization in preparation for global marketing application submissions. The candidate must have an in-depth understanding of oncology drug development, and senior PM experience building a team to support late stage registrational programs and facilitate approval of marketing applications in accordance with corporate directives and goals. Specifically, responsibilities include, but are not limited to:

• Project management of Core Filing Teams including the detailed operational planning and execution of global marketing applications, ensuring timely delivery of high-quality dossiers.
• Develops and maintains detailed integrated submission timelines. Communicates progress against key performance indicators, milestones, and risks to Leadership and at governance forums on regular cadence. Develop dashboards for tracking and reporting relevant metrics.
• Proactively identifies operational pain points; recommends and implements solutions, including process refinements and outsourcing opportunities, as appropriate.
• Partners closely with Global Registration Lead and Global Regulatory Lead(s) early in development to drive strategic planning and resourcing of new drug applications for global health authority submission and approvals.
• Supports planning and execution of Health Authority Interactions for key submission related milestones ensuring appropriate documented follow up and communication back to Leadership and Cross-Functional Submission Teams.
• Coordinates with global partners and stakeholders on program plans and timelines, ensuring compliance, consistency and alignment across geographies.
• Implements Regulatory PM portfolio level dashboards, including detailed metrics of ongoing and planned global HA applications, to inform cross-functional resource loading, shared clinical, quality and regulatory risks, baseline assumptions, and progress against key performance indicators.
• Works with relevant functions to integrate detailed MAA submission status updates into the broader set of portfolio metrics reports.
• Builds, manages and scales a team of direct reports and provides mentorship to junior professionals as applicable.

Required Skills, Experience And Education:

• Bachelor’s degree in life sciences or related discipline. Advanced degree preferred.
• Has 12+ years of industry experience in biotech and/or pharma, with at least 8 years of experience in Program Management in clinical development, ideally with recent experience within oncology drug development.
• Experience supporting clinical & commercial stage programs & execution of global marketing applications (US, EU, and ideally experience in Japan.)
• Excellent planning, organizational and executive presentation skills with the ability to work simultaneously on multiple projects within narrow timelines.
• Excellent communication skills to manage internal negotiations, meeting management, group dynamics, and balance concerns of line management with objectives of Cross Functional Submission Teams.
• Ability to rationalize both strategically and tactically and be present recommendations to senior leaders and key stakeholders.
• Experience managing the financial aspects of project management, including planning, negotiating, budgeting, and reporting.

Preferred Skills:

• Experience in oncology development and studies including combination studies, multiple expansion cohorts, basket or umbrella master protocols highly preferred. #LI-Hybrid  #LI-SH1

The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.

Please note that base pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.

Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.

Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com.

Base Pay Salary Range$236,000—$295,000 USD