Key Responsibilities:
- Ownership of Clinical Supply Chain activities including planning, labeling, packaging and distribution of Investigational Medicinal Product for multiple projects.
- Primary point of contact with contract manufacturing partners.
- Forecast supply needs in conjunction with Clinical and CMC colleagues.
- Work with Finance to develop budgets and manage costs for clinical supply activities.
- Support global supply and procurement strategy development, including vendor selection.
- Utilize appropriate software/IT systems to manage key project activities and effectively manage customer expectations.
- Forecast program-level and study-level needs; partner with CMC to design packaging and stability needs.
- Work with cross-functional teams (Clinical Operations and CMC) to develop program-wide supply plans.
- Medical Device packaging and labeling.
Requirements:
- Bachelorβs degree in a relevant discipline and 4+ years of experience in Clinical Supplies/Supply Chain, Clinical Operations, Quality, or CMC in a Biotech/Pharmaceutical/CRO environment (or equivalent combination of education and experience).
- Working knowledge of regulations for clinical labeling, packaging and distribution activities (cGMP, GCP).
- Knowledge of Interactive Voice/Web response systems for clinical studies.
- Experience with Medical Devices in Clinical Trials.
- Clinical Supply management experience using contract manufacturing companies.
Application/Location/Compensation:
- Hybrid role requiring 3 days/week onsite at Boston HQ.
- Pay range: $116,800 - $175,200. Eligible for annual bonus and annual equity awards; some roles may be eligible for overtime.