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BioNTech SE · 1 day ago

Associate Director, Clinical Trial Supply Management IMPM

Cambridge, MA

Full-time

Onsite

Lead/Staff, Director/Executive

5+ years exp

BioNTech SE is focused on leading global clinical supply strategies that impact patient care. The Associate Director of Clinical Trial Supply Management will orchestrate supply strategies for global clinical trials, ensuring timely delivery of therapies and compliance with regulatory standards.

Health Care

Responsibilities

Define and lead initiatives for CTSM portfolio activities, ensuring alignment with platform portfolio strategies and clinical trial requirements

Develop and oversee distribution, manufacturing, and supply planning strategies for platform portfolios

Manage performance objectives and performance management for trials within the platform portfolio

Ensure platform portfolio requirements are followed across all related clinical trials

Oversee planning activities at the platform portfolio level, orchestrating the needle-to-needle supply process

Liaise with interfaces to address trial escalations and prioritizations

Provide CTSM feasibility perspectives to platform portfolio core teams

Provide guidance to Managers IMPM during trial setup, execution, and closeout phases

Train new team members to follow SOPs and ensure adherence to IMPM standards

Ensure compliance with GCP and GMP principles, as well as Quality Management Systems

Coordinate and compile regulatory documents, ensuring accuracy and consistency

Build and maintain strong relationships with internal and external stakeholders, ensuring alignment and effective communication

Qualification

Clinical Trial Supply ManagementGCPGMP principlesProject ManagementIRT systemsQuality Management SystemsBusiness-professional EnglishStrategic thinkingNegotiation abilitiesDecision-making skills