Senior Director, Clinical Supply Chain - Fremont - Bayside Solutions

    Bayside Solutions
    Bayside Solutions Fremont

    3 days ago

    Default job background
    Pharmaceutical / Bio-tech
    Description

    Senior Director, Clinical Supply Chain

    A hybrid role in Redwood City, CA, this position plays a crucial part in our Pharmaceutical Development and Manufacturing organization.

    Key Responsibilities:

    • Lead a team to plan and deliver clinical supplies on-time, ensuring compliance with the clinical development plan.
    • Collaborate with cross-functional teams (Clinical Operations, QA, PDM, and Regulatory) to identify and mitigate potential risks affecting clinical programs.
    • Serve as the clinical supply lead for assigned program(s), developing and managing the clinical supply plan.
    • Manage clinical supply and logistics activities, including demand forecasting, IRT start-up and maintenance, label generation, packaging operations, release and distribution, expiry extension, cold chain management, and inventory management.
    • Author, review, and approve related clinical and technical documents, such as clinical label text, master batch records, and IND/NDA filings.
    • Identify, select, onboard, and manage vendors for combo agent/comparator sourcing and secondary packaging and distribution.
    • Develop continuous improvement plans for clinical supply GMP, GDP, and business processes, serving as a Subject Matter Expert.

    Requirements and Qualifications:

    • Bachelor's or Master's degree in a scientific field, 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.
    • Familiarity with import and export laws and processes.
    • Working knowledge of pharmaceutical drug product development and manufacturing.
    • Excellent organizational and time management skills.
    • Effective communication skills (verbal and written).
    • Capable of working on multiple projects and meeting deadlines.
    • Team-oriented, progressive thinker who thrives in an innovative environment.

    Desired Skills and Experience:

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

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