Manager, Clinical Supplies

Arena Pharmaceuticals San Diego , CA 92140

Posted 4 months ago

Manager, Clinical Supply Chain

The Opportunity

Arena is a growing, fast-paced organization with a start-up mentality. We need a Manager, Clinical Supply Chain who will coordinate the uninterrupted supply of clinical trial materials (CTM) to clinical sites ensuring study timelines are met. You will manage overall CTM inventory, and may also be called upon to play a support role in protocol review, regulatory filings and contract management.

Our Technical Operations group is responsible for the supply and management of clinical trial materials (CTM) supporting the conduct of the company's multiple clinical development programs. The Manager, Clinical Supply Chain is a critical, hands-on role within the company that affords considerable opportunity to practice the processes and activities involved with ensuring that patients in Arena's clinical studies have access to the important medicines that the company is developing throughout the world to treat a wide range of clinical indications. The position will be responsible for coordinating efforts between manufacturing, quality, clinical operations and regulatory team members to provide timely availability of high quality CTM to clinical study sites and to manage the return and disposition of excess materials.

The ideal candidate will strive for operational excellence, proposing opportunities for improvement and identifying areas of risk through cross-functional collaboration with various functional departments.

What you'll dive into

  • Evaluating CTM demand forecast to create and manage supply plans

  • Managing CTM inventory at study depot(s) and site(s)

  • Managing outsourced packaging, labeling and distribution of CTM for small POC studies and global clinical trials

  • Leads contract negotiations with vendors or CMOs

  • Manages vendor documentation required for movement of investigational product (IP) domestically and internationally

  • Oversees IRT/IWRS/IXRS system development (URS and UAT) and inventory management

  • Reviews protocols, batch records, specifications, reports, regulatory filings, SOPs, etc.

  • Manages European Qualified Person (QP) product release requirements

What we're expecting

  • BA/BS degree with proven experience in clinical supply management/coordination

  • Hands-on laboratory and/or pharmaceutical development experience

  • Superior written communication and MS Word and Excel skills

  • Working knowledge of ICH guidelines, GCP's, 21CFR and Annex 13 requirements.

  • Knowledge of CMC, preferably with prior hands-on experience

  • Knowledge of CMO/vendor selection process

Bonus skills

  • Experience with cold chain management

  • Regulatory document authoring, coordination and/or submission

  • Ability for occasional travel

What you'll get

  • To be a part a growing company and fantastic team passionate about developing novel drug therapies to improve people's lives

  • Opportunities to learn and contribute creative solutions

  • Comprehensive health insurance ($0 premium on select medical plans)

  • Matching 401k retirement plan

  • Paid time off and holidays

  • Company celebrations

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Manager, Clinical Supplies

Arena Pharmaceuticals