Job Details

Overview

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 RAS(ON) Inhibitors are designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors are 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 Opportunity

The Temp Director of Regulatory Science (Early Development) is accountable for the delivery of regulatory science and strategy for designated early-stage programs at RevMed. They will support programs and drug development teams and ensure delivery of targeted, pragmatic, well-vetted, consistent and actionable regulatory advice for designated programs. The Director must have a thorough understanding of and be experienced in oncology drug development, applicable regulations, and current health authority thinking, and have strong leadership and relationship-building ability.

• Independently deliver sound regulatory science and strategy support to early development program teams (pre-IND through EOP1/2)
• Ensure drug development programs are fully resourced for the applicable stage of development and all relevant regulatory requirements are met
• Anticipate upcoming work; ensure robust and effective regulatory support.
• Ensure regulatory science takes account of competitive developments, evolving regulatory guidance, expert feedback, and that advice is aligned with company goals and objectives
• Ensure regulatory advice, policy and decision-making is consistent across programs and that learnings from one program are fully considered in other programs.
• Establish highly collaborative and effective relationships with colleagues in Clinical Research, Clinical Operations, Clinical Pharmacology, Nonclinical, Regulatory, Medical Writing, PM, Quality and other functions to ensure cross-functional alignment and team effectiveness.

Required Skills, Experience and Education

• 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
• Demonstrated success in leading early stage regulatory submissions globally (IND, CTA, FDA meeting packages)
• 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.

Preferred Skills

• An advanced degree is desirable.
• Experience with combination studies, multiple expansion cohort, basket or umbrella and master protocols highly preferred.

This is a contract position that will be employed through a third-party recruiting agency. The agency will provide the pay range, which will be based on several factors, including job-related skills, experience, market conditions, and relevant education or training.

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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