Associate Director, Clinical Supply Chain

Centessa Pharmaceuticals•Boston, MA

5d•Onsite

About The Position

Centessa Pharmaceuticals is seeking an Associate Director, Clinical Supply Chain to develop and implement strategies for delivering Investigational Product (IP) to support several clinical programs. This role involves developing strong collaborative relationships with internal departments and third-party providers to ensure clinical supply. The successful candidate will demonstrate strong attention to detail in managing clinical forecasts, inventory databases, and IRT systems, providing daily oversight of clinical supplies. Management and travel to CDMOs, both domestically and internationally, may be required.

Requirements

Bachelor’s degree in engineering or science is required.
7+ years of biotech/pharma industry experience in clinical supply with significant international experience is required.
Experience in all aspects of clinical supply chain.
Deep understanding of GMP/GDP.
Strong understanding of managing groups, CMOs, CDMOs, and other CDMOs.
Strong organizational, analytical, decision-making, and interpersonal skills.
Ability to work on multiple projects independently in a fast-paced dynamic environment.
Demonstrated ability to coordinate CDMO activities in the development and commercialization of pharmaceutical products.
Excellent organizational skills, project management skills, and detail-oriented leadership approach.
Willing and able to travel both domestically and internationally.

Responsibilities

Develop and update clinical supply strategies to meet corporate demands.
Develop and maintain strong collaborative relationships with internal departments and external CDMOs.
Identify potential supply chain risks and develop and implement negotiated mitigation strategies.
Manage study/program budget, contracts, and change orders, and track spend against budget.
Develop and, in collaboration with Clinical, regularly update forecast/demand plans for late-phase clinical trials.
Collaborate with Quality, Clinical, CMC, and external CDMOs to develop and approve clinical labels.
Manage CDMO packaging/labeling schedules to ensure availability of clinical supplies.
Interact regularly with third-party providers to manage logistics and licenses required to ship materials from manufacturing to bulk storage facilities, courier depots, and investigator sites.
Work with CMC and QA to facilitate document transfer required for IP/QP release by CDMOs.
Manage and track clinical supply inventory either manually or through an Interactive Response Technology (IRT) system.
Manage Product Recovery pending investigation of IP from investigator sites as needed.
Effectively collaborate and communicate across multiple functional areas, bringing a sufficient breadth of knowledge.
Monitor shelf-life and expiry dating and coordinate retest extension with the analytical team to ensure continuous supply.
Manage investigation, reporting, and communication of outcomes from temperature excursions and product complaints.
Author and/or review supply chain sections of regulatory submissions.
If required, participate as SME in audits or for-cause inspection of CDMOs.
Contribute as a SME to the CDMO selection and approval process and review of associated Master Service Agreements (MSA) and Quality Agreements for clinical supply services.
Represent Supply Chain in Clinical and CMC Sub Team meetings.