Revolution Medicines

Revolution Medicines

Director, Regulatory Affairs Companion Diagnostics (CDx)

Redwood City, California, United States · Director · Full-time

Sponsorship not specified$211k-$264kDetected 1 day ago
ComplianceNegotiationFDA RegulatoryPCRMolecular BiologyNGSLeadershipCommunicationOrganizational SkillsRegulatory Affairs

About the role

  • Provide strategic regulatory guidance for companion diagnostic development plans, analytical and clinical validation, bridging strategies, labeling, and lifecycle management.
  • Participate in regulatory interactions with FDA (CDRH and CDER), EMA, PMDA, and other global health authorities regarding companion diagnostic development and registration.
  • Ensure regulatory alignment between therapeutic and diagnostic submission timelines.

Responsibilities

  • Develop and execute global regulatory strategies for companion diagnostics supporting oncology drug development programs from early development through commercialization.
  • Partner closely with external diagnostic manufacturers to support successful co-development, regulatory submissions, inspections, and post-approval activities.
  • Drive regulatory risk assessment and mitigation strategies to support development milestones and product approvals.
  • Develop and maintain strong collaborative relationships across Regulatory Science, Clinical Development, Translational Medicine, Commercial, and external partners.
  • Support development of regulatory policies, procedures, and best practices for companion diagnostics across the organization.

Requirements

  • Strong understanding of biomarker development, assay validation, analytical performance studies, clinical performance studies, and companion diagnostic lifecycle management.
  • This individual must possess a strong understanding of global in vitro diagnostic (IVD) regulations, companion diagnostic development, oncology drug development, and evolving global regulatory expectations.

Skills

  • Deep knowledge of FDA companion diagnostic guidance, PMA requirements, IDE regulations, IVDR, and global IVD regulatory frameworks.
  • Experience leading regulatory interactions with FDA CDRH and CDER, EMA, PMDA, and other international health authorities.
  • Demonstrated success managing regulatory aspects of drug-diagnostic co-development programs through product approval.
  • Experience working with external diagnostic partners.
  • Proven ability to influence cross-functional teams and integrate regulatory strategy across drug and diagnostic development organizations.
  • Experience representing Regulatory Affairs to senior leadership and executive governance committees.
  • Advanced degree (PhD, PharmD, MD, MS, or equivalent) is preferred.
  • Experience supporting global oncology registration programs involving companion diagnostics.
  • Working knowledge of EU IVDR implementation and international companion diagnostic regulations.
  • Experience supporting next-generation sequencing (NGS), PCR-based, or multiplex molecular diagnostics.
  • #LI-Hybrid #LI-JC1
  • The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below.

Compensation

  • $211,000 - $264,000 USD
  • 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.

Benefits

  • The successful candidate will be a collaborative leader with demonstrated experience managing complex cross-functional programs and interactions with health authorities and diagnostic partners.

Company info

  • 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.
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This listing is sourced directly from Revolution Medicines's careers page and normalized into a canonical job model.