Senior Manager / Associate Director, Clinical Drug Supply

Senior Manager/Associate Director, Clinical Drug Supply - Permanent - Massachusetts

Proclinical is seeking a dedicated and motivated Senior Manager/Associate Director for Clinical Drug Supply. This position holds a hybrid working model with 3 days required to be worked on-site in Massachusetts.

Primary Responsibilities:

This role will manage the supply of Clinical Trial Material (CTM) through all stages of clinical development, ensuring continuous supply and compliance with regulatory standards. You will collaborate with various teams and vendors to develop and implement effective clinical supplies strategies.

Skills & Requirements:

• BA/BS degree with relevant experience in clinical supply chain management.
• Ability to prioritize and manage multiple projects effectively.
• Strong problem-solving and negotiation skills.
• Excellent communication skills for dealing with stakeholders.
• Proficiency in Microsoft Office Suite, especially Excel for material planning.
• Understanding of regulatory requirements for clinical supply distribution is advantageous.
• Willingness to travel up to 10% for meetings as required.

The Senior Manager / Associate Director, Clinical Drug Supply's responsibilities will be:

• Oversee drug management for multiple clinical trials, ensuring compliance with GMPs and effective project management.
• Lead the creation and approval process for clinical label text and manage global trial labeling activities.
• Manage relationships with Contract Packaging Vendors for packaging, labeling, and distribution.
• Collaborate with vendors and CROs on IRT system requirements and drug supply management.
• Handle vendor management, including contract negotiations and performance accountability.
• Develop study Pharmacy Manuals in collaboration with key stakeholders.
• Manage inventory, track expiry extensions, and coordinate site close-out activities.
• Support clinical supply activities for ongoing and new trials, including demand forecasting and resupply planning.
• Contribute to protocol and document reviews, understanding clinical supply sections.

If you are having difficulty in applying or if you have any questions, please contact Ed Little at e.little@proclinical.com

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.