Reporting to the Head of Supply Chain, the Senior Manager/Associate Director will be responsible for both day-to-day operational, and longer-term strategic activities within a rapidly growing supply chain organization. In this role you will be assigned specific programs to independently manage, along with responsibility for key vendor relationships and/or dedicated strategic initiatives as the company and function matures. Our Clinical Development motto is “Patients first; integrity without exception".
- You will oversee clinical supply packaging, labeling, distribution, and returns/reconciliation requirements for all studies within assigned program(s), from study start up through closeout.
- Collaborate with the Master Planner to develop a robust long-range demand forecast and supply plan, based on study and program requirements.
- Develop individual budgets, and ensure financial adherence and contracted service levels are achieved with external partnerships.
- Liaise with Clinical Operations, QA, TechOps, and Regulatory Affairs colleagues to support critical development milestones, while always ensuring on-time delivery of drug to patients.
- Facilitate packaging and labeling design and execution for IMP, ConMeds, and comparators; set up distribution networks (including global depots), and manage import/export requirements as required.
- Collaborate with Supply Chain Systems lead to configure, test (UAT), implement, and administer IRT/IxRS systems in support of study enrollment and clinical supply management.
- Actively manage study and program level risk, along with optimizing time and cost of clinical supply operations.
- Ensure appropriate documentation is generated and maintained in compliance with domestic and international regulations.
- Support the growth and success of colleagues within the supply chain group, and in the larger organization.
- Lead key strategic initiatives as assigned.
- Additional duties and responsibilities as required.
- 5-7 years' experience in a supply chain role in biotech/pharma (Senior Manager); or 8-10 years' experience in a supply chain role in biotech/pharma (Associate Director).
- Strong track record of successful collaboration with key cross-functional stakeholders in Clinical Operations, QA, Regulatory, TechOps, and external vendor partners.
- End to end supply chain expertise in a variety of trial phases, and geographic regions.
- Thorough understanding of GxP requirements and global import/export best practices.
- IRT development/configuration, testing, and administration experience.
- Excellent project management, communication, and technical skills.
- Adept problem solver who sees opportunities, not roadblocks, and can juggle multiple competing priorities.
- Flexible and positive “get it done” attitude should be coupled with strong EQ and sense of humor.
- Oncology experience is a plus; knowledge of rare diseases is preferred.