Director, Clinical Supply Chain

Alkermes•Waltham, MA

1d•$196,000 - $216,000•Hybrid

About The Position

The Director, Clinical Supply Chain is a senior program-level leader in Alkermes’ Pharmaceutical Development organization. Reporting to the Senior Director, Clinical Supply Chain, this role owns 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 represents Clinical Supply Chain on program, CMC, and study teams; sets supply strategy for assigned programs; oversees Associate Directors and other team members; and manages vendor relationships and program-level budgets. Working with Clinical Operations, Regulatory Affairs, Quality, Finance, Trade Compliance, and internal and external manufacturing partners, the Director ensures uninterrupted, compliant, and cost-effective investigational product supply to global clinical trial sites. The Director may act as deputy for the Senior Director when required. The role leads program supply planning and execution, including demand forecasting, manufacturing and packaging coordination, distribution and inventory oversight, risk mitigation, returns and close-out, and IRT/IXRS strategy. It also oversees vendor performance, budget forecasting, regulatory and inspection readiness, and continuous improvement of procedures and work instructions. The position follows a hybrid workplace model, with work performed onsite at the Waltham, Massachusetts office at least three days per week and the balance from home; it is not eligible for fully remote work. Domestic and international travel of up to 15% is required. The annual base salary range is $196,000–$216,000, and the position is eligible for an annual performance pay bonus. Alkermes offers a competitive benefits package; specific benefits are not listed in the posting.

Requirements

Bachelor’s degree in Life Sciences, Pharmacy, Supply Chain, Business, or a related field and at least 13 years of progressive clinical supply chain experience, or a Master’s degree and at least 10 years of experience.
Demonstrated success leading clinical supply for multiple concurrent global programs, including Phase 3 studies, from start-up through trial completion.
In-depth knowledge of diverse clinical trial designs, including randomized, double-blind, double-dummy, placebo-controlled, and cross-over studies, and their supply chain implications.
Expert proficiency in global demand forecasting, inventory management, supply simulation tools, and IRT/IXRS systems.
Comprehensive understanding of GMP, GCP, controlled-substance management, DEA regulations, and global import/export requirements.
Experience managing CMOs, depots, and logistics providers, including scopes of work, contracts, KPIs, and program budgets.
Experience leading and developing people directly or through matrix teams.
Exceptional communication, negotiation, and influencing skills, including presenting recommendations to senior leadership and leading cross-functional teams.
Strong record of independently managing and prioritizing complex projects in a dynamic global environment and making sound strategic decisions.
Advanced proficiency in Microsoft Excel, PowerPoint, and IRT systems.
Willingness and ability to travel domestically and internationally up to 15%.
Ability to work onsite at the Waltham, Massachusetts office at least three days per week under the hybrid workplace model.

Nice To Haves

Advanced certifications such as APICS CPIM or CSCP.
Experience with Smartsheet, SharePoint, Microsoft Project, and Planview.

Responsibilities

Serve as accountable clinical supply lead for multiple concurrent programs, owning the most complex, global, and late-stage studies.
Represent Clinical Supply Chain on program, CMC, and study teams and contribute supply chain input to development plans, 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 trial protocols and study designs for supply feasibility, cost, and risk.
Prioritize supply activities and allocate team resources in alignment with the Senior Director and departmental goals.
Escalate program-level risks, decisions, and trade-offs with clear recommendations.
Lead creation and approval of clinical supply and demand plans, establish planning assumptions, and review plans prepared by team members.
Partner with Clinical Operations to validate demand assumptions and enrollment plans, review actuals, and use simulation tools to optimize supply decisions.
Translate clinical demand into manufacturing, packaging, and labeling requirements and coordinate timing with manufacturing partners.
Direct packaging and labeling strategies to improve efficiency, minimize waste, and meet global regulatory requirements.
Oversee U.S. and global distribution, depot and site inventory, import/export activities, and controlled-substance management in compliance with DEA regulations.
Identify supply risks and lead mitigation and contingency plans to prevent disruptions.
Oversee drug returns, reconciliation, destruction, and clinical site close-out for assigned programs.
Lead IRT/IXRS strategy, including User Requirement Specifications, system design review, and User Acceptance Testing, and promote consistent standards across studies.
Own operational relationships with CMOs, packaging and labeling vendors, depots, third-party logistics providers, and IRT vendors.
Define vendor scopes of work, review proposals and change orders, monitor performance against contracts and KPIs, and escalate strategic issues.
Collaborate with Quality Assurance on vendor qualification, audits, and quality-event resolution.
Develop, manage, and forecast program-level clinical supply budgets; coordinate with project managers and Finance on forecasting, tracking, reporting, and cost-saving targets.
Provide program-level input to annual budgets and long-range planning.
Ensure program activities comply with GMP, GCP, and global regulations.
Lead cross-functional contributions to regulatory submissions, address Health Authority queries on clinical supply, and represent Clinical Supply Chain in inspections and audits.
Ensure timely and accurate filing of clinical supply documentation in the Trial Master File.
Author, review, and continuously improve Clinical Supply Chain SOPs and work instructions.
Lead and develop people through direct or matrix-team leadership.
Travel domestically and internationally up to 15%.