Senior Director, Clinical Supply Chain

Company:  Bayside Solutions
Location: Santa Clara
Closing Date: 08/11/2024
Hours: Full Time
Type: Permanent
Job Requirements / Description

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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