Senior Director, Clinical Trial Supplies

Role Summary

The Senior Director, Clinical Trial Supplies leads end-to-end clinical supply planning in a fast-paced biotech environment. This role performs strategic clinical supply management for clinical development programs (phase 1–3) and supports commercial launch, reporting to the SVP, Technical Operations. The position collaborates with Global Supply Chain and cross-functional teams to develop supply chain strategies, manage IMPs, and ensure timely distribution of clinical materials globally.

Responsibilities

• Serve as the clinical supply lead on CMC sub-teams and Clinical Operations teams for complex development programs.
• Lead development and execution of overall clinical supply strategy and management for clinical programs, including management of IMP for global and domestic trials.
• Oversee and support clinical study planners in a matrix environment; facilitate issue and risk identification, mitigation, resolution and communication.
• Drive cross-functional decision-making to support long-term vision.
• Identify, manage and mitigate supply risks; drive process improvements and organizational changes.
• Author, revise, and review SOPs, work instructions, and business policies.
• Manage the clinical supply budget for assigned programs.
• Review and approve statements of work, purchase orders, and invoices; influence program allocations with CMOs.
• Oversee contract packaging and distribution vendor operations, including budget, timelines, specifications, labeling, logistics, and QP interactions.
• Ensure timely domestic and international distribution of Clinical Trial Materials; plan inventory and monitor usage, expiry, returns, transfers, and destruction.
• Forecast demands for clinical supplies and coordinate production and shelf-life extension with related teams.
• Select, implement, and manage IRT systems from setup to close-out with Data Management and Clinical Operations.
• Create and manage a global team of professionals in clinical supplies; provide mentorship.
• Develop strategic project and resource plans; provide guidance on drug supply requirements to senior management.
• Build and maintain a network of CROs, CDMOs, and packaging/distribution facilities.
• Establish supply chain strategy for comparators, rescue medications, and ancillary meds for trials.
• Integrate cross-functional teams to deliver compliant clinical trial materials; review labels, manuals, and SOPs.
• Manage scope, cost, timelines, and quality of integrated clinical trial supplies plans.
• Contribute to regulatory filings and support Quality Assurance in quality system implementation and inspections.
• Other duties as assigned.

Qualifications

• Education and Experience: Bachelor's degree in life sciences, engineering, business, or related field with at least 15 years of related experience in the pharmaceutical industry in clinical supplies management, including at least 10 years in a supervisory role (master‚Äôs degree with at least 13 years of experience acceptable).
• Rare diseases/oral solid dosage forms experience is a plus; global clinical supplies organization building is highly desirable.
• Import/export management of drug substance/product, importer of record selection, and VAT strategies familiarity.
• Understanding of CGMP/CGCP, compendia testing, and ICH/regulatory guidelines including stability data.
• Strong cross-functional collaboration, excellent project management, and superior written/oral communication skills.
• Experience with regulatory document preparation is desirable; ability to manage competing priorities in a fast-paced environment.
• Strong organizational skills and ability to work under pressure; knowledge of industry trends and technologies.

Skills

• Clinical supply chain management
• Program leadership and strategic planning
• Vendor management (CMOs, CROs, CDMOs)
• Budgeting and financial oversight
• IRT systems and data management integration
• Cross-functional collaboration and communication

Education

• Bachelor‚Äôs degree in life sciences, engineering, or business (or related discipline); Master‚Äôs degree is considered with appropriate experience.

Additional Requirements

• Travel up to 20% may be required.
• Physical demands: standard office environment; occasional lifting up to 25 lbs may be required.