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
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Desired Skills and Experience Clinical supply chain, oncology, drug development, global phase III studies