Job Description

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.

Responsibilities

• 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.

Qualifications

• Bachelor's degree in a related field with a minimum of 12 years' progressive experience in clinical supply chain or a Master's degree in Supply Chain, Business, or a relevant discipline with at least 10 years' experience. Advanced certifications such as APICS (CPIM, CRIM, CSCP) are strongly preferred.
• Demand planning, drug product demand forecasting and data analytics. Experience with N-Side and/or other demand forecast systems.
• Develop key clinical supply chain metrics. Develop and maintain automated program and study level dashboards with key supply chain metrics.
• Experience running global clinical studies, including strategic oversight of clinical study design, execution, and management of study drug supply 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.
• Demonstrated expertise in global inventory management, including advanced proficiency with IXRS/IRT systems and leading forecasting of global drug supply requirements.
• Comprehensive understanding of GMP and/or GCP, controlled substance management, and DEA regulations, with experience overseeing compliance in a regulated environment.
• Exceptional communication, negotiation, and influencing skills with a proven ability to build and lead cross-functional teams and partnerships; outstanding attention to detail.
• Strong track record of independently managing and prioritizing complex projects in a dynamic, global environment, with demonstrated strategic decision-making abilities.
• Advanced proficiency in Microsoft Excel, PowerPoint, demand forecasting, and IRT systems required. Experience with Smartsheet, SharePoint, Microsoft Project, and Planview highly desirable.
• Willingness and ability to travel domestically and internationally up to 15% to support business objectives and cross-site collaborations.

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 $170,000 - $182,000. 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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