Associate Director, Clinical Trial Supply Management IMPM

Role Summary

Associate Director, Clinical Trial Supply Management IMPM — Cambridge, US (full time). Lead global clinical supply strategies for Phase I-III trials, defining and guiding Clinical Trial Supply Management IMPM-Portfolio activities and ensuring timely, compliant delivery of therapies.

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.

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.
• Proficiency in IRT systems and standard office software (e.g., MS Office).
• Extensive knowledge of performance management in IMPM and Quality Management Systems.
• Ability to lead individuals with diverse professional backgrounds and expertise levels.
• Strong decision-making skills, strategic thinking, and negotiation abilities.
• Business-professional English language proficiency.

Skills

• Strategic portfolio management
• Clinical trial supply planning
• GCP/GMP compliance
• IRT systems proficiency
• Stakeholder management
• Leadership and team development