Jobs · OTHR · California

Director, Analytical Development

Revolution Medicines · San Francisco Bay Area · 1 wk ago
HybridOTHR$211k–$264k/yrFull-time

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, including 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, currently in clinical development.

About the Role

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 of 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.

Requirements

  • PhD or Master’s in Analytical Chemistry, Organic Chemistry, or a related scientific discipline.
  • 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 a strong preference for late-phase development, regulatory approval, and commercialization readiness.
  • Excellent communication, collaboration, people leadership, and stakeholder management skills.
  • 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.
  • Ability to prioritize and lead multiple initiatives in a fast-paced, dynamic, and highly collaborative environment.

Preferred Qualifications

  • PhD preferred (minimum MS) in Analytical Chemistry, Organic Chemistry, or a related scientific discipline.

Pay

The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is $211,000 - $264,000 USD. The range displayed is intended for individuals working onsite in Redwood City and will be adjusted for the local market where a candidate is based. Individual base pay salary is determined by multiple factors, including job-related skills, experience, and market dynamics.

Base pay salary is one part of the overall total rewards program at Revolution Medicines, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.

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