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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. They will also be involved in 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. Will collaborate and interact 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). This position will report to the Head of Clinical Supplies Planning and Logistics, in the Clinical Development Operations department.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- As part of the Clinical Supplies Planning and Logistics team, manages clinical supply and logistics activities, including but not limited to demand forecasting and 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.
- Management of IP vendors (performance, quality, timelines, results, costs): participates in review of RFP, reviews IP services vendors budgets.
- Collaborates with external partners (CMOs, CROs, shipping and IRT vendors, study sites) and study team members to ensure successful execution of clinical trials
- Collaborates with Clinical Operations and Regulatory Affairs to provide packaging and labeling strategy, including labeling and packaging design in compliance with relevant SOPs, polices, and regulations
- Works closely with QA to ensure compliance around IP documentation, procedures, Lot numbers, managing expiration dates, and coordinating release schedules.
- Manages 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. Supports inspection team in preparation for and during regulatory agency inspection.
- Ensures appropriate documentation of IP supply activities is provided to clinical trial teams for the Trial Master File.
- Provides input to drug kit randomization specifications and reviews master kit lists
Education
- 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 of 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
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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