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BioNTech SE · 1 day ago

Manager, Clinical Trial Supply Management IMPM

Cambridge, MA

Full-time

Onsite

Mid Level

3+ years exp

BioNTech SE is a leading biotechnology company focused on transforming the lives of patients through innovative therapies. The Manager, Clinical Trial Supply Management IMPM will drive clinical supply excellence across global trials, ensuring investigational medicines reach patients on time and in compliance, while managing initiatives in global Phase I-III clinical trials.

Health Care

Responsibilities

Lead the coordination and execution of assigned clinical programs/trials, acting as the primary interface between CTSM internal functions and trial teams

Serve as the point of contact for other departments (e.g., GCO, CMC, PM, GRA), attend cross-functional meetings, and ensure trial set-up requirements are followed across functions

Own and maintain the Clinical Supply Summary, consolidate information from various departments, and ensure consistency and accuracy across trial-related documents (e.g., CDP, CTP, IB, Monitoring Plan, IMPD/IND sections)

Liaise with internal and external stakeholders to improve clinical trial processes, align with CMC on product properties, and translate clinical forecasts into kit demand/patient units

Prepare IMP and IRT sections for investigator meetings, liaise with GCP Compliance for CRO trainings, and ensure adherence to ethical and regulatory standards

Manage and coach Specialist CTSM IMPM team members, fostering a culture of collaboration, innovation, and accountability

Qualification

Clinical Trial Supply ManagementGCP knowledgeProject ManagementIRT systems proficiencyMS Office proficiencyOpenness to new topicsBusiness-professional EnglishProblem-solving mindsetWork ethicCollaboration skills

Required

A relevant university degree in Supply Chain Management, Pharmacy, Chemistry, Biotechnology, Biochemistry, or a related discipline

At least 3 years of experience in Clinical Trial Supply Management or Project Management within the pharmaceutical or biotech industry, ideally in ClinDev, ClinOps, or Clinical Supply

Proven track record in managing clinical trials, with knowledge of GCP and GMP principles

Proficiency in IRT systems and standard office software (e.g., MS Office)

Strong project management skills and the ability to solve multi-layered, dynamic challenges

Business-professional English language proficiency

A strong work ethic, problem-solving mindset, and openness to exploring new topics and setting trends