Senior Manager, Clinical Bioanalytical Outsourcing

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The companys R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team you will join other outstanding Revolutionariesin a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The Opportunity:

• The Clinical Bioanalytical Lead is responsible for the strategic oversight and operational execution of bioanalytical activities supporting clinical development programs. This role serves as the primary point of contact for Contract Research Organizations (CROs) performing bioanalytical method development validation and sample analysis ensuring high-quality compliant and timely delivery of bioanalytical data to support clinical trials and regulatory submissions.

• Act as the primary scientific and operational liaison for bioanalytical CROs supporting clinical studies.

• Provide oversight of CRO bioanalytical activities including method development validation sample analysis and data reporting.

• Review and approve bioanalytical sample analysis plans validation reports bioanalytical reports.

• Draft and review the pharmacokinetics components of a clinical protocol lab manual and other study associated documents.

• Ensure CRO performance meets agreed timelines quality standards and contractual obligations.

• Lead issue resolution deviation investigations and CAPA discussions related to bioanalytical work.

• Partner closely with Clinical Pharmacology Clinical Operations Clinical Data Science and Quality teams.

• Contribute to integrated development team discussions and provide bioanalytical expertise across programs.

• Ensure bioanalytical activities are conducted in compliance with GLP/GCP internal SOPs and regulatory guidance.

• Maintain inspection-ready documentation and traceability for all bioanalytical activities.

• Facilitate clinical PK header reconciliation.

Required Skills Experience and Education:

• MS in Analytical Chemistry Pharmacokinetics drug metabolism or a related scientific discipline with 7 years of relevant industry experience or BS with over 10 years of relevant industry experience.

• In-depth knowledge and hands-on experience with LC/MS/MS and quantitative analysis of small molecules in complex biological matrices.

• Knowledge and hands-on experience with large molecule quantitation in complex biological matrices.

• Good understanding of regulatory guidelines for regulated bioanalysis.

• Experience in regulatory BA submissions interactions and addressing IRs from regulatory agencies.

• Excellent interpersonal oral and written communication skills.

• Thrives in a collaborative team setting and is driven by a desire to be innovative in a high energy small company environment.

Preferred Skills:

• Hands on experience in GLP.

• Experience in supervising BA CRO.

• Experience in supporting NCA in Phase 1 Phase 2 clinical trials.

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