Associate Director, Clinical Supply Chain

• Oversee, update, and monitor program budgets while ensuring alignment with financial Key Performance Indicators (KPIs) and achievement of cost-saving targets.
• Provide strategic direction for clinical program supply strategy, ensuring integration of trial design, enrollment timelines, manufacturing readiness, and regulatory requirements
• Develop and maintain study and program level automated dashboards with key supply chain metrics.
• Evaluate clinical trial protocols and provide expert guidance on supply chain implications
• Partner with Clinical Operations to validate demand assumptions and review enrollment plans and actuals for the development of robust supply requirements plans
• Create and manage supply demand forecast for multiple programs based on patient enrollment forecasts. Utilize simulation tools to optimize clinical supply planning.
• Design and implement packaging and supply strategies to maximize efficiency, minimize waste, and proactively identify risks, developing comprehensive risk mitigation plans
• Monitor enrollment activity and inventory levels to ensure demand requirements are consistently met, ensuring seamless coordination of supply chain processes
• Provide strategic oversight of U.S. and global distribution and logistics for clinical programs, ensuring seamless execution and alignment with organizational objectives.
• Lead proactive inventory management at depots and clinical sites throughout all trial phases; implement preventative strategies to mitigate and resolve potential supply disruptions.
• Oversee the end-to-end drug returns and clinical site close-out processes, ensuring compliance and accuracy in the preparation and review of comprehensive drug reconciliation reports.
• Direct the development and management of clinical labeling strategies, ensuring regulatory compliance and operational efficiency.
• Provide leadership in the design, review, and implementation of IXRS systems, driving acceptance testing and ensuring systems meet program needs.
• Lead development of IRT User Requirement Specifications and oversee User Acceptance Testing to support robust clinical supply chain solutions.
• Serve as the primary liaison with external partners, clearly communicating project requirements and ensuring alignment with strategic objectives.
• Ensure timely and accurate updates to Trial Master Files (TMF) with essential supply chain documentation, supporting regulatory readiness and audit compliance.
• Drive operational excellence by contributing strategic insights and recommendations to planning and budgetary processes, supporting achievement of departmental and organizational goals.
• Champion continuous professional development by engaging in educational opportunities, maintaining industry knowledge, and fostering a network of key relationships within the field.
• Lead cross-functional collaborations on regulatory submissions, address queries from Health Authorities, and represent the supply chain function during regulatory inspections.
• Establish, review, and continuously improve SOPs and work instructions, ensuring operational excellence and compliance across Clinical Supply Chain activities.
• Direct selection and application of advanced simulation tools to optimize clinical supply strategies and drive data-driven decision making.

The Associate Director position within Clinical Supply Chain provides strategic leadership and oversight for end-to-end supply chain management across multiple clinical programs as part of a growing, dynamic Pharmaceutical Development organization. Serving as the primary point of contact, the Associate Director collaborates closely with Clinical Operations, Regulatory Affairs, Quality, Internal & External Manufacturing, and other Clinical Supply Chain personnel, leading complex supply activities that often require multinational coordination. Additionally, this role is responsible for building and maintaining strong partnerships with both internal and external stakeholders, ensuring alignment with organizational objectives. The successful candidate will demonstrate leadership in a highly collaborative team environment, driving the successful development and delivery of new drugs.

Why join Team Alkermes?

Alkermes applies its decades of deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we seek to make a meaningful difference in the way people manage their diseases. We have a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy, and a pipeline of clinical and preclinical candidates in development for various psychiatric and neurological disorders.

We are proud to have been recognized as an employer of choice by many national organizations. In 2024 and 2025, we were certified as a Great Place to Work in the U.S. and named one of Massachusetts' Top Places to Work by the Boston Globe, a Best Place to Work in Greater Cincinnati by the Cincinnati Business Courier and recognized as a Best Place to Work in BioPharma by Fortune Magazine.

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.