Senior Manager, Clinical Supply Management

Responsibilities:

• Plan and manage investigational medicinal product (IMP) supply to ensure uninterrupted patient dosing for assigned clinical studies.
• Create and maintain study forecast and supply plans; develop clinical labels; execute packaging and labeling activities; manage distribution, inventory, and returns & reconciliation.
• Develop and update clinical supplies distribution plans based on program/study timelines, trial design, program changes, recruitment, geography, and manufacturing schedules.
• Source ancillary supplies; coordinate with CMC to ensure ancillary compatibility with IMP.
• Develop and manage SOPs, work instructions, processes, systems, and forms for clinical supplies management in line with industry standards and regulatory requirements.
• Manage IMP shelf-life extensions, temperature deviation management, product complaints, and related investigations.
• Identify and review potential supply chain vendors.
• Oversee global clinical CMO network supporting drug supply (DP release through final packaged goods release); schedule/oversight of label/pack execution; ensure materials/components availability.
• Coordinate manufacturing requirements; drive CMO capability and capacity for on-time delivery of packaged clinical product.
• Manage operational pack activities with focus on cost, quality, metrics, delivery, and technology objectives; intervene proactively if timelines/goals are at risk.
• Prepare RFQs/SOWs and negotiate clinical supply agreements.
• Lead as manufacturing outsourcing team leader for clinical finished good packaging cross-functional teams.
• Support QA with QA agreements and ensure Product Specific Requirements (PSRs) are established before projects begin.
• Apply expert judgment to independently solve complex problems and champion process improvements.

• 4-year college degree (relevant discipline preferred).
• Thorough understanding of GMP, GCP, and ICH standards for IMP labeling, packaging, and global distribution.
• Strong vendor management skills.
• Ability to work proactively with minimal supervision, accurately and on time.
• Proficient in MS Office (Word, Excel, PowerPoint) and Smartsheet.
• Teamwork and independence; strong interpersonal, written, and verbal communication.
• Ability to prioritize and evaluate task impact on study execution.
• Strong problem-solving, collaboration, organizational, multitasking, and attention to detail.

• 6–8+ years in clinical supply chain management and/or PM role.
• Experience with electronic interactive response technologies for inventory management.
• ERP experience.

• Onsite role; expectation to be in the office five days a week.
• Authorization to work in the country where role is located is required.