Associate Director, Clinical Supply Chain

Revolution Medicines • Redwood City, CA

5h • $186,000 - $233,000 • Hybrid

About The Position

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company’s 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 Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
The Opportunity:
Playing a critical role within the Pharmaceutical Development and Manufacturing (PDM) organization, the position will be responsible for planning and delivering clinical supplies to support RevMed’s clinical development programs.
Serve as the clinical supply lead for assigned program(s) and develop/manage the clinical supply plan.
Plan and deliver on-time, compliant clinical supply per the clinical development plan.
Collaborate with cross-functional teams (i.e. Clinical Operations, QA, PDM, and Regulatory) to ensure continued advancement of the clinical programs.
Lead and manage clinical supply and logistics activities, for blinded as well as open label studies, including but not limited to: 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, and inventory management.
Author, review, and/or approve related clinical and technical documents, including but not limited to: 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.

Nice To Haves

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

Responsibilities

• Serve as the clinical supply lead for assigned program(s) and develop/manage the clinical supply plan.
• Plan and deliver on-time, compliant clinical supply per the clinical development plan.
• Collaborate with cross-functional teams (i.e. Clinical Operations, QA, PDM, and Regulatory) to ensure continued advancement of the clinical programs.
• Lead and manage clinical supply and logistics activities, for blinded as well as open label studies, including but not limited to: 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, and inventory management.
• Author, review, and/or approve related clinical and technical documents, including but not limited to: 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director