- Lead a team to 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 proactively identify and mitigate potential risks to the continued advancement of the clinical programs.
- Serve as the clinical supply lead for assigned program(s) and develop/manage the clinical supply plan.
- 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.
- Lead vendor identification, selection, onboarding, and management for combo agent/comparator sourcing and secondary packaging and distribution.
- Serve as a subject matter expert and develop continuous improvement plans for clinical supply GMP, GDP, and business processes.
- B.S. or M.S. in scientific fields with 15+ years of experience in clinical supply chain and logistics.
- 5+ years of experience building and/or managing a clinical supply chain team.
- Strong experience managing clinical supply activities for global phase 3, randomized, oncology clinical trials.
- 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.
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Senior Director, Clinical Supply Chain - Redwood City, United States - Revolution Medicines, Inc.
Description
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 scientists 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 leading a team to plan and deliver clinical supplies to support RevMed's clinical development programs.
Required Experience, Skills, and Education:
An individual's position within the range may be influenced by multiple factors, including skills and experience in role, overall performance, individual impact and contributions, tenure, and market dynamics.
Base salary is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.
Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition and veteran status.
Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone.
We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy.
For additional information, please contact
