Manager, Clinical Supply Chain
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
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