Director, Clinical Supply Chain

Alkermes

18h•Hybrid

About The Position

The Director, Clinical Supply Chain is a senior program-level leader within the 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, complex clinical programs, including late-stage and pivotal studies, from study start-up through close-out and commercial transition. The role represents Clinical Supply Chain on program and CMC teams; sets supply strategy for assigned programs; oversees Associate Directors and other team members; manages key vendor relationships and program-level budgets; and acts as a deputy for the Senior Director when required. The Director partners with Clinical Operations, Regulatory Affairs, Quality, Finance, Trade Compliance, and internal and external manufacturing to ensure uninterrupted, compliant, and cost-effective supply of investigational products to patients at global clinical trial sites. The role is hybrid, based at the Waltham, Massachusetts office, with at least three days onsite per week and the remaining time from home; it is not eligible for fully remote work. Domestic and international travel of up to 15% is expected.

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 as clinical supply lead for multiple concurrent global programs, including Phase 3 studies, from start-up through trial completion.
In-depth knowledge of 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 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 directly or through matrix teams.
Exceptional communication, negotiation, and influencing skills, including presenting recommendations to senior leadership and leading cross-functional teams.
Strong track 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, MA office at least three days per week under the hybrid workplace model.

Nice To Haves

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

Responsibilities

Lead a portfolio of concurrent clinical programs as the accountable clinical supply lead, with direct ownership of the most complex, global, and late-stage studies.
Represent Clinical Supply Chain on program, CMC, and study teams, contributing supply chain expertise 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 protocols and study designs early in development, providing guidance on supply feasibility, cost, and risk.
Prioritize supply activities and allocate team resources in alignment with the Senior Director and departmental goals; escalate program risks, decisions, and trade-offs with recommendations.
Lead creation and approval of clinical supply and demand plans, set planning assumptions, and review plans developed by team members.
Partner with Clinical Operations to validate demand assumptions and enrollment plans and actuals; use simulation tools to optimize supply strategies and inform decisions.
Translate clinical demand into manufacturing, packaging, and labeling requirements and coordinate timing with internal and external manufacturing.
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 compliant controlled substance management.
Identify supply risks and lead mitigation and contingency plans to prevent disruptions.
Oversee drug returns, reconciliation, destruction, and clinical site close-out processes.
Lead IRT/IXRS strategy, including User Requirement Specifications, system design review, and User Acceptance Testing; promote consistent standards across studies.
Own operational relationships 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, 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; partner with program 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 clinical supply activities comply 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 inspections and audits.
Ensure timely and accurate filing of clinical supply documentation in the Trial Master File for inspection readiness.
Author, review, and continuously improve Clinical Supply Chain SOPs and work instructions.
Lead and develop team members and support continuous improvement of clinical supply activities.