Senior Director, Clinical Trial Supplies

Role Summary

The Senior Director, Clinical Trial Supplies is an end-to-end clinical supply planning leader in a fast-paced biotech environment, responsible for strategic clinical supply management across phase 1–3 programs and support for commercial launch. Reports to the SVP, Technical Operations.

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; lead process improvements and organizational change.
• Author, revise, and review SOPs, work instructions, and policies.
• Manage clinical supply budget for assigned programs; review and approve statements of work, purchase orders, and invoices.
• Influence program allocations with partners including CMOs.
• Oversee contract packaging and distribution vendor operations, including budget, timelines, specifications, packaging records, labeling, logistics, and QP interactions.
• Ensure timely global distribution of Clinical Trial Materials; plan inventory and monitor usage, expiry, returns, transfers, and destruction.
• Forecast demands and coordinate production and shelf-life extension with relevant teams.
• Select, implement, and manage IRT systems from setup to close-out.
• Create and manage a global team of professionals in clinical supplies.
• Develop strategic project/resource plans and provide guidance on drug supply requirements.
• Build and maintain a network of CROs, CDMOs, and packaging/distribution facilities appropriate to development phases.
• Establish supply chain strategy for comparators and rescue meds to support trials.
• Integrate cross-functional teams to deliver fit-for-use materials compliant with regulatory standards.
• Review global clinical labels, pharmacy manuals, and SOPs for clinical supplies.
• Manage scope, cost, timelines, and quality of integrated clinical trial supplies plans.
• Contribute to regulatory filings (INDs, IMPDs, NDAs, briefs, dossiers).
• Support QA with quality system implementations and regulatory inspections.
• Other duties as assigned.

Qualifications

• Required: Bachelor‚Äôs degree in life sciences, engineering, business, or relevant discipline with at least 15 years of related technical experience in clinical supplies management, plus a minimum of 10 years in a supervisory role (or Master‚Äôs with at least 13 years and similar supervisory experience).
• Experience in rare diseases or oral solid dosage forms is a plus.
• Experience building a global clinical supplies organization is highly desirable.
• Import/export management of drug substances/products, including importer of record selection and VAT strategies.
• Understanding of CGMP/CGCP, ICH, regulatory guidelines, and stability data requirements.
• Strong cross-functional collaboration, project management, and communication skills.
• Experience with regulatory document preparation is desired.
• Ability to work in a goal- and team-oriented setting with competing priorities; detail-oriented and well-organized under pressure.
• Knowledge of industry trends and technologies.

Skills

• Clinical supply planning
• Vendor management (CMOs, CROs, CDMOs)
• Budget management
• SOP and policy development
• IRT systems management
• Cross-functional leadership
• Regulatory documentation
• Risk assessment and mitigation

Education

• Bachelor‚Äôs degree required; Master‚Äôs degree preferred

Additional Requirements

• Travel up to 20% may be required.
• Physical demands not specified as essential beyond standard office environment.