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Head of Development Management & Compliance

$211k - $264k

Revolution 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. 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.Provide strategic and organizational leadership for analytical development activities supporting small molecule API and drug product development, including oversight of phase appropriate control strategies, specification setting, analytical lifecycle management, and overall CMC analytical strategy.Lead and oversee analytical development execution across internal and external teams to support the development, characterization, and manufacturing of API and drug product, while actively contributing to cross functional PDM project teams.Provide strategic guidance and oversight for regulatory submission activities, including authoring and review Quality sections of regulatory submissions, and leading responses to regulatory queries.Establish and drive analytical strategies, technology selection, and operational execution through effective management of CDMOs, CROs, and contract laboratories, with accountability for quality, timelines, risk management, and delivery.Provide leadership oversight for preparation, review, and approval of analytical protocols, reports, specifications, investigations, and technical documentation to ensure scientific excellence, regulatory compliance, and inspection readiness.Build strong cross functional partnerships and influence across Drug Product, Drug Substance, Regulatory Affairs, QA, Project Management, Medicinal Chemistry, DMPK, Toxicology and senior leadership teams to drive strategic decision making and achievement of program and organizational goals.Required Education, Experience and Skills:PhD or Masters in related field.10+ years of progressive leadership experience in analytical development within the pharmaceutical or biotechnology industry.Proven ability to lead cross functional teams, influence organizational decision making, and drive execution of complex development strategies in a matrix environment.Extensive strategic and operational leadership experience overseeing analytical activities across small molecule drug development, with strong preference for late phase development, regulatory approval, and commercialization readiness.Deep understanding of CMC strategies and analytical enablement for small molecule development programs.Demonstrated leadership experience managing external partners, including CROs and CDMOs, to ensure high quality deliverables and program execution.Strong knowledge of global regulatory requirements and experience supporting regulatory submissions, including INDs, IMPDs, NDAs, and/or MAAs.In-depth understanding of ICH guidelines, GMP regulations, and current industry best practices related to analytical development and quality.Strong strategic thinking and innovation mindset with the ability to independently evaluate complex issues, identify risks, and implement effective solutions.Preferred Skills:PhD preferred (minimum MS) in Analytical Chemistry, Organic Chemistry, or a related scientific discipline. #LI-Hybrid #LI-CT1The 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. 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. 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.

Vacancy posted 1 day ago
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