Director, Clinical Supply Chain

The Director, Clinical Supply Chain is a senior program-level leader within a growing, dynamic Pharmaceutical Development organization. Reporting to the Senior Director, Clinical Supply Chain, the Director is accountable for end-to-end clinical supply strategy and execution across a portfolio of high-priority and complex clinical programs, including late-stage and pivotal studies, from study start-up through close-out and commercial transition.

The Director serves as the Clinical Supply Chain representative on program and CMC teams, sets supply strategy for assigned programs, oversees the work of Associate Directors and other team members on those programs, and manages key vendor relationships and program-level budgets. Partnering closely with Clinical Operations, Regulatory Affairs, Quality, Finance, Trade Compliance, and internal and external manufacturing, the Director ensures the uninterrupted, compliant, and cost-effective supply of investigational products to patients at global clinical trial sites, and acts as a deputy for the Senior Director when required.

Program and Portfolio Leadership

• Serve as the accountable clinical supply lead for a portfolio of multiple concurrent clinical programs, with direct ownership of the most complex, global, and late-stage studies.

• Represent Clinical Supply Chain on program, CMC, and study teams; provide supply chain input to clinical development plans, program timelines, and portfolio decisions.

• Develop and own program-level clinical supply strategies that integrate trial design, enrollment timelines, manufacturing readiness, and global regulatory requirements.

• Evaluate clinical trial protocols and study designs early in development and provide expert guidance on supply chain feasibility, cost, and risk.

• Prioritize supply activities and allocate team resources across assigned programs in alignment with the Senior Director and departmental goals.

• Escalate program-level supply risks, decisions, and trade-offs to the Senior Director and program leadership with clear recommendations.

Supply Planning and Operational Execution
 

• Lead the creation and approval of clinical supply and demand plans for assigned programs; set planning assumptions and review plans developed by Associate Directors and other team members.

• Partner with Clinical Operations to validate demand assumptions and review enrollment plans and actuals; apply simulation tools to optimize supply strategies and drive data-driven decisions.

• Translate clinical demand into manufacturing, packaging, and labeling requirements and coordinate timing with internal and external manufacturing.

• Direct packaging and labeling strategies that maximize efficiency, minimize waste, and comply with global regulatory requirements.

• Provide oversight of U.S. and global distribution, depot and site inventory management, and import/export activities, including controlled substance management in compliance with DEA regulations.

• Proactively identify supply risks and lead development and execution of mitigation and contingency plans to prevent supply disruptions.

• Oversee drug returns, reconciliation, destruction, and clinical site close-out processes for assigned programs.

• Lead IRT/IXRS strategy for assigned programs, including User Requirement Specifications, system design review, and User Acceptance Testing; promote consistent IRT standards across studies.

Vendor and Budget Management

• Serve as the primary operational relationship owner with CMOs, packaging and labeling vendors, depots, third-party logistics providers, and IRT vendors for assigned programs.

• Define vendor scopes of work, review proposals and change orders, and monitor vendor performance against contracts and KPIs; escalate strategic vendor issues to the Senior Director.

• Collaborate with Quality Assurance on vendor qualification, audits, and resolution of quality events.

• Develop, manage, and forecast program-level clinical supply budgets; partner with program project managers and Finance to ensure transparency in forecasting, tracking, and reporting and achievement of cost-saving targets.

• Contribute program-level inputs to annual budget and long-range planning processes.

Compliance and Inspection Readiness

• Ensure clinical supply activities for assigned programs are executed in compliance with GMP, GCP, and global regulations.

• Lead cross-functional contributions to regulatory submissions, address Health Authority queries on clinical supply topics, and represent Clinical Supply Chain during regulatory inspections and audits.

• Ensure timely and accurate filing of clinical supply documentation in the Trial Master File (TMF) to support inspection readiness.

• Author, review, and continuously improve SOPs and work instructions governing Clinical Supply Chain activities.
   

People Leadership and Continuous Improvement 

• Ensure clinical supply activities for assigned programs are executed in compliance with GMP, GCP, and global regulations.

• Lead cross-functional contributions to regulatory submissions, address Health Authority queries on clinical supply topics, and represent Clinical Supply Chain during regulatory inspections and audits.

• Ensure timely and accurate filing of clinical supply documentation in the Trial Master File (TMF) to support inspection readiness.

• Author, review, and continuously improve SOPs and work instructions governing Clinical Supply Chain activities.

• Bachelor’s degree in Life Sciences, Pharmacy, Supply Chain, Business, or a related field with a minimum of 13 years’ progressive experience in clinical supply chain, or a Master’s degree with at least 10 years’ experience. Advanced certifications such as APICS (CPIM, CSCP) are preferred.

• Demonstrated success as clinical supply lead for multiple concurrent global programs, including late-stage (Phase 3) studies, from start-up through trial completion.

• In-depth knowledge of diverse clinical trial designs (e.g., randomized, double-blind, double-dummy, placebo-controlled, cross-over) and their implications for supply chain strategy.

• Expert proficiency in global demand forecasting, inventory management, supply simulation tools, and IRT/IXRS systems.

• Comprehensive understanding of GMP and GCP, controlled substance management, DEA regulations, and global import/export requirements.

• Proven experience managing CMOs, depots, and logistics providers, including scopes of work, contracts, KPIs, and program budgets.

• Experience leading and developing people, either directly or through matrix teams.

• Exceptional communication, negotiation, and influencing skills, with the ability to present recommendations to senior leadership and lead cross-functional teams.

• Strong track record of independently managing and prioritizing complex projects in a dynamic, global environment, with sound strategic decision-making.

• Advanced proficiency in Microsoft Excel, PowerPoint, and IRT systems; experience with Smartsheet, SharePoint, Microsoft Project, and Planview highly desirable.

• Willingness and ability to travel domestically and internationally up to 15%.

Alkermes has recently adopted a hybrid working environment to support and meet the needs of employees and this role will operate in a flexible environment with 60% of time in the office and 40% from home. This position is eligible for the hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office at least 3 days per week. This role is not eligible for fully remote work.

The annual base salary for this position ranges from $196,000 to $216,000. In addition, this position is eligible for an annual performance pay bonus.  Exact compensation may vary based on skills, training, knowledge, and experience. Alkermes offers a competitive benefits package.  Additional details can be found on our careers website: www.alkermes.com/careers#working-here  

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