Senior Director & Therapeutic Area Head, Regulatory Affairs
$244k - $305kRevolution Medicines
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: * Provide management and leadership of one or more therapeutic areas for late-stage oncology programs. * Oversee the development of global regulatory therapeutic area and product strategies to drive product development, global registration, , and effective regulatory agency interactions. * Provide regulatory expertise and guidance to therapeutic area commercialization teams and other governance bodies. * Foster the career development of staff within the therapeutic area and contribute to departmental leadership activities. * Ensure alignment and consistency across programs within a therapeutic area based on regulatory intel, research, and competitive landscape. Primary Responsibilities: * Direct the development of global regulatory strategy from registrational studies to marketing application across one or more therapeutic areas. * Lead and mentor GRLs/Study Leads in the development of global regulatory strategies, in partnership with regional regulatory leads, including precedence, risk management and contingency planning. * Partner with regional regulatory leads to incorporate regional regulatory, scientific, clinical, and market insights into integrated disease area and product strategies. * Communicate to management aligned global regulatory strategy and plans for a therapeutic area to support portfolio and life cycle management. * Conduct management review and approval of key documents for regulatory submissions and governance communications. * Contribute to the target product profile and evaluation of probability of regulatory success. * Monitor, assess and communicate to staff impact of relevant global regulations, guidance, and current regulatory environment. * Advise on global health authority interactions and participate on core regulatory and cross-functional teams to ensure effective agency interactions. * Provide managerial leadership & direction to staff within the therapeutic area, allowing appropriate prioritization of resources to achieve corporate goals. * Provide coaching, mentoring, and development of staff, ensuring staff are compliant with Revolution Medicine’s corporate and departmental policies and procedures. 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 including regulatory strategy and leadership roles. * Prior marketing application filing experience. Demonstrated success in obtaining health authority approvals. * Demonstrated ability in leading teams, establishing organizational direction, and championing continuous improvements.
- Direct experience with global oncology drug development.
- Experienced in representing Regulatory on cross functional teams and
- An advanced degree is desirable.
- Experience with combination studies, multiple expansion cohort, global
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$244,000—$305,000 USD
-------------------------------------------------------------------------------- We are aware of recent recruitment scams in which individuals or organizations falsely represent themselves as being affiliated with Revolution Medicines. These scams may appear as false job advertisements or unsolicited contacts through communication or chat platforms, email, phone, or text message. Please note that Revolution Medicines does not extend unsolicited employment offers and will never ask candidates to provide financial information, purchase equipment, or pay fees as part of the hiring process. All legitimate communication from Revolution Medicines will come from an official @revmed.com email address. If you believe you’ve been contacted by someone impersonating a Revolution Medicines recruiter, please report it to View email address on click.appcast.io so we can share these impersonations with our IT team for tracking and awareness. --------------------------------------------------------------------------------- ...intersection of People, Legal, and Operations and ensures we meet regulatory requirements while supporting a great employee experience. You... ...to mitigate risk. Collaboration and Support Partner with the Director of People Operations and leadership team on compensation and...SeniorFull timeH1bWork at office
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