Associate Director, Clinical Supply Chain

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.

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.