Senior Manager, Clinical Supply Management

Scorpion Therapeutics; Madison (WI); On-site; USD 110,000 - 150,000; Full time

Job summary

Scorpion Therapeutics in Madison, WI seeks an experienced Clinical Supply Chain Lead to manage IMP supply and ensure uninterrupted patient dosing across studies.

You will develop and maintain study forecasts, packaging and labeling, distribution, inventory and returns, and collaborate with CMC to ensure ancillary compatibility with IMP. Onsite daily presence is required, with strong GMP/GCP knowledge.

Qualifications

• 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 and ability to work proactively with minimal supervision.
• Proficient in MS Office (Word, Excel, PowerPoint) and Smartsheet; team player with strong communication.

Responsibilities

• Plan and manage IMP supply to ensure uninterrupted patient dosing for assigned clinical studies.
• Create and maintain study forecasts 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 timelines, trial design, and manufacturing schedules.
• Source ancillary supplies and coordinate with CMC to ensure ancillary compatibility with IMP.
• Develop and manage SOPs, work instructions, processes, systems, and forms for clinical supplies management.
• Oversee GMP/GCP/ICH compliant processes and manage shelf-life extensions and deviations.
• Identify and review potential supply chain vendors; oversee global CMO network for DP release and packaging.
• Coordinate manufacturing requirements; drive CMO capability and capacity for on-time delivery.
• Lead outsourcing teams for clinical finished good packaging; support QA agreements and PSRs.
• Apply expert judgment to solve complex problems and champion process improvements.

Skills

Communication

Vendor management

Problem solving

Multitasking

Attention to detail

Education

Bachelor's degree in a relevant discipline

Tools

MS Office

Smartsheet

ERP systems

Job description

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.

Requirements:

• 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.

Preferred:

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

Application/Other:

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