Senior Director, Global Regulatory Affairs Project Management

Senior Director Of 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 :

Preferred Skills :

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.

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