Sr. Director, Clinical Supply Chain

Alkermes Plc

Waltham, MA

JOB DETAILS
SKILLS
Acceptance Testing, Budget Management, Budgeting, Business Growth, Business Strategy, CMOS, Clinical Trial, Clinical Trial Management, Continuous Improvement, Corporate Planning, Cross-Functional, Demand Forecasting/Planning, Disease, Documentation, Drug Development, Financial Compliance, Financial Planning, Forecasting, GMP (Good Manufacturing Practices), Insurance Regulations, Inventory Management, Investigational New Drug (IND), Leadership, Legal, Maintain Compliance, Medical Products, Mentoring, Neurology, Neuroscience, Operational Strategy, Operations Management, Performance Metrics, Pre-Clinical Development, Program Planning, Psychiatry and Mental Health, Quality Assurance, Regulations, Relationship Management, Sales Management, Set Goals, Simulation, Standard Operating Procedures (SOP), Supply Chain, Third-Party Logistics (3PL), Vendor/Supplier Evaluation
LOCATION
Waltham, MA
POSTED
30+ days ago

Strategic Leadership

Develop and execute global clinical supply chain strategies aligned with corporate and clinical development goals. Lead long-range planning and drive the continued development and transformation of supply chain infrastructure to meet the needs of the growing business. Partner with Legal, Finance, Trade Compliance, Quality Assurance, Regulatory Affairs, Clinical Operations, CMC Teams, and other functions across the internal network, to deliver responsibilities aligned with business goals.

Operational Oversight

Oversee demand forecasting, inventory management, and supply planning using simulation tools. Manage packaging, labeling, distribution, and returns of clinical trial materials (CTM) in compliance with GMP and global regulations. Lead IRT system design, implementation, and user acceptance testing for effective drug tracking and randomization.

Vendor and Budget Management

  • Lead senior level business relationship management with CMOs and third-party logistics providers
  • Develop and ensure adherence to contracts and KPIs
  • Collaborate with Quality Assurance leadership on vendor qualification and audits
  • Develop and manage clinical supply budgets, ensuring cost-effective operations
  • Partner with program project managers to align clinical supply budgets with overall program financial planning and ensure transparency in forecasting, tracking, and reporting

Compliance and Inspection Readiness

Ensure inspection readiness for global regulatory audits. Maintain documentation and SOPs to support compliance and continuous improvement.

Team Leadership

Mentor and continue to build a high-performing clinical supply chain team. Foster a culture of accountability, innovation, and cross-functional collaboration.

Strategic Leadership

An exciting opportunity to lead the strategic and operational management of complex clinical supply activities across all phases of development to provide life-changing therapeutics for patients. The Senior Director of Clinical Supply Chain ensures the uninterrupted, compliant, and cost-effective delivery of investigational products to global clinical trial sites.

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.

About Alkermes

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.

Equal Employment Opportunity

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.

About the Company

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Alkermes Plc