Associate Director, Clinical Supply Chain

Revolution Medicines•Redwood City, CA

10d•Onsite

About The Position

Revolution Medicines is a global, commercial-stage oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform, the company is advancing a broad, integrated portfolio of oral RAS(ON) inhibitors designed to directly target the active, cancer-driving state of RAS. Founded on rigorous scientific inquiry and a willingness to challenge long-held assumptions, Revolution Medicines is committed to changing the trajectory of disease for patients with RAS-addicted cancers worldwide. Our people are united by a shared way of working: follow the science, challenge assumptions, act with urgency and hold ourselves to a high standard of rigor—all in service of patients. 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.