Manager, Clinical Supplies Planning and Logistics

Job Description

Position Summary:

Manager, Clinical Supplies Planning and Logistics. Structure is seeking a talented, independent, and highly motivated Senior Manager, Clinical Supplies Planning and Logistics with experience in clinical supply planning and logistics. The manager will perform typical Clinical Supplies Manager activities including forecasting Investigational Product (IP) supply requirements, inventory management, and managing packaging, labeling, and distribution through 3rd party vendors for one or more clinical trials.

The role will collaborate internally with Clinical Operations, Medical Monitors, Program Management, Quality, Regulatory, Tech Ops/CMC and externally with Clinical Service Providers (e.g., IRT, CROs, IP Drug Depots) and report to the Head of Clinical Supplies Planning and Logistics in the Clinical Development Operations department.

• Manage clinical supply and logistics activities including demand forecasting, supply planning, label generation and approval, packaging and labeling operations at clinical supply vendors, release and distribution, temperature excursion, expiry extension, drug return and destruction records, and inventory management.
• Manage IP vendors (performance, quality, timelines, results, costs): participate in RFP review and review IP services vendors budgets.
• Collaborate with external partners (CMOs, CROs, shipping and IRT vendors, study sites) and study team members to ensure successful execution of clinical trials.
• Collaborate with Clinical Operations and Regulatory Affairs to provide packaging and labeling strategy, including labeling and packaging design in compliance with relevant SOPs, policies, and regulations.
• Work closely with QA to ensure compliance around IP documentation, procedures, lot numbers, managing expiration dates, and coordinating release schedules.
• Manage the design and review of IP-related study documents (e.g., pharmacy manual, IP section of protocol) and training materials for clinical study teams and investigational site use as needed. Support inspection team in preparation for and during regulatory agency inspection.
• Ensure appropriate documentation of IP supply activities is provided to clinical trial teams for the Trial Master File.
• Provide input to drug kit randomization specifications and review master kit lists.

• BA/BS required, scientific discipline preferred. Other BA/BS degree with IRT and clinical supply experience will be considered.

• Understanding and proven experience in IRT/RTSM in large global blinded studies.
• 6+ years of relevant experience in the biotechnology/pharmaceutical industry, including at least 3 years in clinical supply management using IRT in a small biotech-type environment.
• Experience in small molecules (capsule and tablet) clinical supply planning and logistics for multi-center, blinded global studies preferred.
• Experience in IP logistics in Latin America preferred.
• Knowledge of global pharmaceutical regulatory requirements: cGMP, GCP, GDP.
• Experience in forecasting, labeling, and distribution in a clinical environment.

The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.