Reporting to the Sr. Director, Clinical Supply Chain, the Associate Director, Clinical Supply Chain Management will provide strategic and operational leadership for end-to-end clinical supply across multiple clinical studies/programs and phases of development. This role is accountable for ensuring reliable supply, proactively identifying and mitigating risk, and driving cross-functional alignment with Clinical Operations, Quality, Regulatory, and external partners. Successful candidates bring a hands-on, solutions-oriented mindset, demonstrate strong judgment and influence, and thrive in a dynamic, fast-paced environment.
This role is based in our Lexington, MA office and requires employees to be onsite five days per week.
Responsibilities (including, but not limited to):- Provide end-to-end clinical supply leadership to ensure continuous supply of clinical trial material for assigned studies globally
- Ensure on-time startup and ongoing execution of new studies by aligning supply timelines, demand assumptions, and operational readiness with study teams
- Lead selection, oversight, and performance management of clinical packaging, labeling, depots, and distribution vendors; drive KPIs, quality, and continuous improvement
- Oversee planning and execution of packaging and labeling campaigns, including master schedule development and issue resolution across stakeholders
- Provide strategic oversight for comparator sourcing, procurement, labeling, and distribution, including complex global sourcing scenarios
- Review clinical protocols and develop fit-for-purpose clinical supply strategies (including IRT strategy) aligned to program needs, timelines, and budget
- Partner cross-functionally with Clinical Operations, Quality Assurance, Regulatory Affairs, CMC/Manufacturing, and Finance to ensure alignment, compliance, and timely decision-making
- Translate protocols and study assumptions into demand forecasts across scenarios; communicate risks, constraints, and recommendations to stakeholders
- Oversee clinical labeling strategy and execution (label design, translation oversight, production, change control) ensuring country and regulatory requirements are met
- Develop and maintain integrated supply plans to support forecasts, including overage strategy, inventory governance, and regular updates to project teams and leadership
- Lead global distribution and logistics strategy for clinical programs, including import/export execution, temperature-controlled shipments, and oversight of 3PL/regional depot networks
- Lead packaging/distribution scope and vendor governance, including contract negotiations, supply plan design, and development/approval of distribution instructions and operational playbooks
- Own risk management for clinical supply (e.g., demand, lead times, quality, distribution), drive mitigation plans, and escalate critical issues with clear options and recommendations
- Provide functional oversight for Interactive Response Technology (IRT) configuration and testing (specification development, UAT coordination, go-live readiness) in partnership with Clinical Operations and vendors
- Oversee study closeout activities including drug reconciliation, returns/destruction strategy, and final inventory disposition in compliance with applicable requirements
- Ensure clinical supply deliverables and documentation are inspection-ready and appropriately filed in the eTMF in alignment with Quality standards
- Develop, manage, and forecast clinical supply budgets for assigned studies/programs; track spend, purchase orders, and accruals; provide financial transparency to stakeholders
- Establish and monitor clinical supply timelines and key milestones; drive issue management, governance, and executive-ready communication for on-time delivery
Stand Out Skills for Impact:- End-to-End Clinical Supply Leadership: Drive seamless global supply across multi-phase trials, ensuring uninterrupted drug availability through strategic planning, demand forecasting, and integrated supply execution
- Risk Mitigation & Strategic Decision-Making: Anticipate supply chain risks, develop scenario-based strategies, and deliver clear, data-driven recommendations to maintain timelines, budget, and compliance
- Vendor & Global Distribution Excellence: Lead selection and oversight of packaging, labeling, and logistics partners; optimize 3PL/depot networks and drive KPIs, quality, and continuous improvement
- Cross-Functional Influence & Execution: Partner with Clinical Ops, QA, Regulatory, CMC, and external stakeholders to align on study timelines, IRT strategy, and operational readiness in fast-paced environments.
Qualifications and Experience:- BS/BA degree required (advanced degree a plus) with 6+ years of progressive experience in Clinical Supply Chain within a biotechnology or pharmaceutical environment, including multi-study/program ownership
- Demonstrated experience leading contract packaging and labeling organizations, including governance, performance management, and issue escalation
- Proven ability to develop and implement risk-based supply strategies across early- to late-stage clinical development programs, including scenario planning and trade-off decision support
- Strong understanding of global regulatory expectations for clinical supply distribution across US, EU, and APAC, including testing, labeling, and import/export requirements
- Deep knowledge of cGMP, GCP, GDP, and transportation requirements for pharmaceutical materials; experience supporting inspection readiness and deviation/CAPA investigations as applicable
- Extensive global distribution experience, including regional depot strategy and operational execution; familiarity partnering with QP release processes and IRT providers
- Strong project/program management skills with demonstrated ability to lead cross-functional teams, influence without authority, and communicate effectively to senior stakeholders
- Thrives in a fast-paced innovative environment while remaining flexible, proactive, resourceful, and efficient; demonstrated ability to develop scalable processes and mentor/train others
Compensation decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks.
Pay Range
$160,000-$181,000 USD
