Senior Director, Regulatory Affairs
Third Rock Ventures - Redwood City, CA
posted 4 days ago
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 professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway. The Senior Director of Regulatory Affairs is accountable for the delivery of regulatory strategy for designated programs at RevMed. They will support programs and drug development teams and ensure delivery of targeted, pragmatic, well-vetted, consistent and actionable regulatory advice. The Senior Director will support policy and process development within regulatory and cross-functionally to define a consistent RevMed approach to regulatory strategy. The Senior Director must have a thorough understanding of and be highly experienced in oncology drug development, applicable regulations, and current health authority thinking, and have strong leadership, relationship-building and executive ability.
Responsibilities
- Deliver sound regulatory strategy to program teams.
- Motivate, mentor and develop direct reports. Level-up the strategic feedback process.
- Ensure drug development programs are fully resourced for applicable stages of development. Anticipate upcoming work; ensure robust and effective regulatory strategy support.
- Ensure regulatory strategy takes account of competitive developments, expert feedback, and that advice is aligned with company goals and objectives.
- Raise team consciousness of regulatory considerations and issues that impact drug development.
- Ensure regulatory advice, policy and decision-making is consistent across programs and that learnings from one program are fully considered in all other programs.
- Establish highly collaborative and effective relationships with management colleagues in Clinical Research, Clinical Operations, Regulatory Affairs, Medical Writing, Quality and other functions to ensure cross-functional alignment and team effectiveness.
Requirements
- Degree in life sciences, pharmacy, medicine, or related fields with a minimum of 12 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 8 years in Regulatory Affairs including regulatory strategy and leadership roles.
- Prior NDA experience. Demonstrated success in obtaining health authority approvals.
- Direct experience with oncology drug development.
- Experienced in representing Regulatory on cross functional teams and presenting to senior management. Excellent communicator.
- Excellent planning and organizational skills and the ability to work simultaneously on multiple projects with tight timelines.
Nice-to-haves
- An advanced degree is desirable.
- Experience with combination studies, multiple expansion cohort, basket or umbrella and master protocols highly preferred.
Benefits
- Competitive cash compensation
- Robust equity awards
- Strong benefits
- Significant learning and development opportunities
