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 Revolutionariesin 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, 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.
Required Skills, Experience and Education:
- 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.