This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Manager/Senior Manager, Clinical Supply Chain based in the United States.
This role oversees clinical drug supply activities across one or more clinical development programs, ensuring patients receive accurate and continuous supplies throughout each study. You will develop supply and inventory strategies spanning demand planning, production, labeling, packaging, and distribution. The position works closely with Clinical Operations, Regulatory, Quality, CMC, CROs, contract manufacturers, and distribution partners. You will manage GMP inventory, monitor production schedules, address supply risks, and drive corrective actions when issues arise. The role also involves IRT strategy and testing, shipment coordination, import licensing, and process improvement. This is an opportunity to contribute to complex clinical programs while helping build efficient, scalable, and reliable clinical supply processes.
Accountabilities:
- Represent Clinical Supply Chain on Clinical Study Teams and serve as a key partner to Clinical Operations, Regulatory, Quality, CMC, and other internal stakeholders, ensuring strong alignment on supply requirements and study timelines.
- Develop comprehensive clinical supply and inventory plans, including production schedules, demand forecasts, supply strategies, and risk mitigation plans designed to maintain continuity while minimizing waste.
- Monitor production schedules and supply performance, identify deviations or potential disruptions, and implement course corrections to maintain appropriate study timelines and inventory levels.
- Manage GMP inventory across the clinical supply chain, including inventory reporting, expiry management, drug accountability, and monitoring of material availability.
- Oversee day-to-day activities with finished-goods labeling and packaging contract manufacturers and distribution vendors, coordinating closely with internal stakeholders and external partners.
- Ensure clinical trial labels and proofs comply with applicable regulations, product specifications, and study protocols, coordinating review and approval with Regulatory, Clinical Operations, CROs, and contract manufacturers as required.
- Support IRT user acceptance testing, develop IRT supply strategies and parameters, and oversee ongoing supply activities within the system.
- Coordinate and track bulk shipments to contract manufacturers, depots, and other vendors while maintaining and monitoring applicable import licenses.
- Investigate supply chain exceptions, determine root causes, implement corrective and preventive actions, and drive issues through to resolution and closure.
- Support functional projects and continuous improvement initiatives, including the creation, revision, and implementation of standard operating procedures and other process documentation.
- Provide guidance and oversight to team members supporting supply planning and business process activities, helping ensure deliverables are completed successfully and study objectives are met.
Requirements:
- Bachelor’s or master’s degree in Business Administration, Operations Management, or a related discipline.
- At least 5 years of progressively responsible experience in supply chain, preferably within the biotechnology, pharmaceutical, or contract research organization (CRO) environment.
- Working knowledge of clinical supply chain best practices, clinical trial material planning, inventory management, labeling and packaging, distribution, and IRT systems.
- Experience working within a cGMP environment and collaborating with cross-functional clinical development teams and external supply partners.
- Strong analytical and problem-solving capabilities, with the ability to assess supply risks, interpret data, identify root causes, and develop effective mitigation strategies.
- Strong organizational and project management skills, including the ability to manage multiple priorities, timelines, stakeholders, and external vendors simultaneously.
- Clear and effective written and verbal communication skills, with the ability to build productive relationships across functions and with external partners.
- Demonstrated initiative, adaptability, continuous-learning mindset, and ability to operate effectively in changing clinical development environments.
- Results-oriented approach with strong attention to detail, sound judgment, and the ability to make data-informed decisions.
- Ability to foster teamwork, provide and receive actionable feedback, act inclusively, and collaborate effectively across diverse teams.
- A continuous improvement mindset and willingness to identify opportunities to strengthen processes, improve efficiency, reduce waste, and support organizational growth.
Benefits:
- Annual base salary range of $114,600–$154,600, with actual compensation determined by factors such as experience, skills, education, certifications, and work location.
- Eligibility for an annual bonus plan for non-commercial roles.
- Eligibility for discretionary equity awards and the opportunity to participate voluntarily in an Employee Stock Purchase Plan.
- Medical, dental, and vision insurance options.
- 401(k) retirement plan.
- Flexible Spending Account (FSA) and Health Savings Account (HSA) options.
- Life insurance coverage.
- Paid time off and wellness benefits.
- Full-time, U.S.-based remote work environment.
- Opportunity to contribute to clinical development programs while working across supply chain, clinical, regulatory, quality, manufacturing, and external partner teams.
- Professional growth through cross-functional collaboration, process improvement initiatives, and increasing responsibility across clinical supply operations.
How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
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