Senior Director, Clinical Supply Chain

Direct Hire Full-Time Role

Salary Range: $235,000 - $265,200 per year

Location: Redwood City, CA - Hybrid Role

Job Summary:

Playing an essential role within our Pharmaceutical Development and Manufacturing organization, you will lead a team to plan and deliver clinical supplies to support our clinical development programs.

Duties and Responsibilities:

• 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 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 approve related clinical and technical documents, including 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.

Requirements and Qualifications:

• 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 and tasks and able to meet deadlines.
• Team-oriented, progressive thinker who enjoys participating in an innovative and creative work environment

Desired Skills and Experience

Clinical supply chain, oncology, drug development, global phase III studies

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