Senior Manager, Clinical Supply Chain

The Opportunity:

Revolution Medicines is seeking a motivated individual to plan, source, make, and deliver clinical supplies to support RevMed’s clinical development programs.   This is an individual contributor role, reporting to the Clinical Supply Chain Director responsible for RevMed’s lead compound.

Responsibilities:

• Serve as the clinical supply lead for assigned study(s) and develop/manage the clinical supply plan.

• Plan, source, make, and deliver on-time, compliant clinical supply per the clinical development plan.

• Collaborate with cross-functional teams (i.e. Clinical Operations, QA, Regulatory, and other PDM Functions) to ensure continued advancement of the clinical programs.

• Led and managed 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.

• Develop, implement, and improve key clinical supply business processes and SOPs and conduct necessary training.

Required Skills, Experience, and Education:

• B.Sc. or M.Sc. in a scientific field with 5+ years of experience in pharmaceutical supply chain.

• Experience managing both strategic and tactical/operational projects.

• Working knowledge of import and export laws and processes.

• Working knowledge of Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP)

• Working knowledge of end-to-end pharmaceutical supply chain and demand/supply planning.

• Working knowledge of small molecule drug development and commercialization.

• Working knowledge of pharmaceutical clinical manufacturing, regulatory, and quality assurance.

• Strong negotiation skills.

• Solid project management, facilitation, and problem-solving skills.

• 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.

• Self-starter with a high level of comfort with ambiguity and complexity and the ability to multi-task while consistently delivering quality results.

• A team-oriented, progressive thinker who enjoys participating in an innovative and creative work environment.

Preferred Skills:

• Experience managing clinical supply activities for global phase 3, randomized, oncology clinical trials. 

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