Director, Clinical Trial Supply Management IMPM

Role Summary

Director, Clinical Trial Supply Management IMPM. Cambridge, US. Lead global strategies for Investigational Medicinal Product Management across Phase I–III clinical trials and oversee IMPM-Platform activities in global Phase I-III trials.

Responsibilities

• Define and lead initiatives for CTSM platform activities, ensuring alignment with organizational goals and clinical trial requirements.
• Develop and implement performance objectives for the IMPM function, driving operational excellence and innovation.
• Design and structure initiatives based on platform portfolio strategies.
• Translate platform portfolio strategies into trial requirements and ensure adherence across all related clinical trials.
• Design distribution, manufacturing, and supply planning strategies for platform portfolios.
• Manage performance management for the IMPM function, ensuring continuous improvement and alignment with organizational goals.
• Define and lead implementation of process initiatives for the IMPM function.
• Provide CTSM feasibility perspectives to platform/portfolio core teams.
• Ensure platform portfolio requirements are followed in trials and oversee execution of assigned clinical portfolios.
• Liaise with internal and external stakeholders to address escalations and identify cross-functional initiatives or new ways of working.
• Lead and mentor individuals with diverse professional backgrounds and expertise, fostering a culture of openness, collaboration, and trust.
• Ensure compliance with GCP and GMP principles, as well as Quality Management Systems.
• Coordinate and compile regulatory documents, ensuring accuracy and consistency.
• Ensure function-specific SOPs are followed and implemented effectively.
• Build and maintain strong relationships with internal and external stakeholders.

Qualifications

• A relevant university degree in Pharmacy, Chemistry, Biotechnology, Biochemistry, or a related discipline. Doctorate preferred, if applicable.
• At least 5 years of experience in Clinical Trial Supply Management within the pharmaceutical or biotech industry.
• Proven track record in managing multiple trial platforms and portfolios, as well as developing platform portfolio strategies for clinical trials.
• Background in Project Management and Operations is preferable.
• Deep knowledge of GCP and GMP principles, including SOPs, documentation, and ethical standards.
• Extensive knowledge of performance management in IMPM and Quality Management Systems.
• Ability to lead individuals with diverse professional backgrounds and expertise, fostering a culture of trust and collaboration.
• Strong decision-making skills, strategic thinking, and negotiation abilities.
• Influencing and project management skills to drive change cross-functionally.
• Business-professional English language proficiency.

Education

• As listed in Qualifications, including any relevant degrees or certifications.