Senior Director, Head of Early Development Regulatory Affairs

Senior Director, Head Of Early Development Regulatory Affairs

Redwood City, California, United States

Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company's R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company's RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The Opportunity:

The Senior Director, Head of Early Development Regulatory Affairs will lead global regulatory strategy for early-stage programs (pre-IND through Phase 2) across the portfolio. This leader will shape innovative and efficient regulatory pathways that enable rapid, science-driven development while positioning assets for long-term success.

In addition to strategic leadership, this role will build and scale fit-for-purpose regulatory processes, frameworks, and capabilities to support portfolio growth. The position reports to the Head of Regulatory Sciences and serves as a key member of the Regulatory leadership team.

Primary Responsibilities:

• Lead global regulatory strategy from candidate selection through end-of-Phase 2.
• Shape early clinical development strategy by providing regulatory leadership on dose-finding approaches and indication selection that enable accelerated and differentiated development pathways and position asset for global registration and Health Authority Engagement.
• Oversee strategy and cross functional alignment for global regulatory interactions and briefing documents (Pre-IND, IND, Scientific Advice, Type B/C meetings, PRIME, Sakigake, etc.).
• Translate agency feedback into clear strategic direction, risk identification and risk mitigation plans.
• Build Scalable Regulatory Infrastructure.
• Design and implement fit-for-purpose early development regulatory processes.
• Establish clear governance, decision-making frameworks (e.g., RACI), and documentation standards.
• Drive operational excellence in early regulatory planning, submission readiness, and execution.
• Identify opportunities to streamline workflows and reduce bottlenecks as the organization grows.

Cross-Functional & Portfolio Leadership:

• Serve as regulatory representative in early development governance forums.
• Advise senior leadership on regulatory risk, timelines, and probability of success.
• Support business development diligence and integration activities.

Organizational & Talent Development:

• Develop and mentor regulatory leaders in early development.
• Build succession depth and technical capability within the function.
• Foster a culture of strategic thinking, accountability, and collaboration.

Required Skills, Experience and Education:

• 8 years of regulatory experience in biotech or pharmaceutical industry required.
• Significant experience leading early development programs (IND-enabling through Phase 2).
• Demonstrated success leading global health authority interactions.
• Experience building or scaling regulatory processes in a growing organization.
• Ability to influence and partner with senior stakeholders.

Preferred Skills:

• 10-12 years of regulatory experience in Biotech/Pharma industry is preferred.
• Experience advising or leading regulatory strategy for basket, umbrella, and platform clinical trials preferred.
• Advanced scientific or clinical degree preferred.
• Demonstrated experience with dose optimization strategies in oncology (Project Optimus) preferred.

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 View email address on click.appcast.io.

Base Pay Salary Range

$244,000 - $305,000 USD

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