Associate Director, Clinical Supply Chain

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), elironrasib (RMC-6291), zoldonrasib (RMC-9805), and RMC-5127, currently in clinical development.

About the role

Playing a critical role within the Pharmaceutical Development and Manufacturing (PDM) organization, you will serve as the clinical supply lead for assigned program(s) and develop/manage the clinical supply plan to support RevMed’s clinical development programs. You will collaborate with cross-functional teams (Clinical Operations, QA, PDM, and Regulatory) to ensure continued advancement of the clinical programs.

Responsibilities

• Plan and deliver on-time, compliant clinical supply per the clinical development plan.
• Lead and manage clinical supply and logistics activities for blinded and open-label studies, including:
  • Demand forecasting and supply planning
  • IRT start-up and maintenance
  • Label generation and approval
  • Packaging and labeling operations
  • Release and distribution
  • Expiry extension
  • Cold chain management
  • Inventory management
• Author, review, and/or approve clinical and technical documents, including:
  • Clinical label text
  • Clinical/master batch record
  • Clinical trial protocol
  • Pharmacy manual
  • IND, IMPD, and NDA
• Support vendor identification, selection, onboarding, and management for combo agent/comparator sourcing and secondary packaging and distribution.
• Conduct necessary training and develop/improve required SOPs.

Requirements

• B.S. or M.S. in scientific fields with 8+ years of experience in clinical supply chain and logistics.
• Working knowledge of import and export laws and processes.
• Working knowledge of pharmaceutical drug product development and manufacturing.
• Solid organizational and time management skills.
• Effective, open, and transparent communication skills (verbal and written).
• Capable of working on multiple projects/tasks and able to meet timelines.
• Team-oriented, progressive thinker who enjoys participating in an innovative and creative work environment.

Preferred Skills

• Strong experience managing clinical supply activities for global phase 3, randomized, oncology clinical trials.
• Experience managing a team, directly or in a matrix setting.

Pay

The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is $186,000 - $233,000 USD. The range will be adjusted for the local market if applicable. Individual base pay salary is determined by job-related skills, experience, market dynamics, and relevant education or training.