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, reporting to the SVP, Technical Operations. Works with Global Supply Chain and cross-functional teams to develop supply chain strategies and ensure timely, compliant distribution of clinical materials worldwide.

Responsibilities

• Serve as the clinical supply lead on CMC sub-teams and Clinical Operations teams for complex development programs.
• Lead the development and execution of overall clinical supply strategy and management for clinical development 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 in support of long-term vision.
• Identify, manage and mitigate supply risks at the program level; lead process improvements and organizational changes.
• Author, revise, and review SOPs, work instructions, and business policies.
• Manage the clinical supply budget of assigned programs; review and approve statements of work, purchase orders, and invoices.
• Influence program allocations at partners including CMOs.
• Oversee contract packaging and distribution vendor operations, including budget, timelines, specifications, packaging records, labeling, logistics, and QP interactions.
• Ensure timely execution of domestic and international distribution of Clinical Trial Materials; plan inventory at warehouse and site levels; monitor usage, expiry, returns, transfers, and destruction.
• Forecast demands for clinical supplies and coordinate production and shelf-life extension with relevant 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; mentor in all matters related to clinical supplies.
• Develop strategic project and resource plans for company clinical supplies and provide guidance to senior management on drug supply requirements.
• Build and maintain a network of CROs, CDMOs, and packaging/distribution facilities appropriate to each development phase.
• Establish supply chain strategy for comparators, rescue medications, and ancillary medications for trials.
• Integrate cross-functional internal and external teams to deliver compliant clinical trial materials.
• Review global clinical labels, pharmacy manuals, and clinical supplies SOPs.
• Manage scope, cost, timelines, and quality of integrated clinical trial supplies plans.
• Contribute to regulatory filing preparation (INDs, IMPDs, NDAs, briefing packages, and related dossiers).
• Support Quality Assurance with quality system implementation and regulatory inspections/audit readiness.
• Other duties as assigned.

Qualifications

• Required: A bachelor’s 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.
• Preferred: Previous experience in rare diseases or oral solid dosage forms.
• Preferred: Prior experience building a global clinical supplies organization.
• Required: Import and export management of drug substance and drug product, including selection of importer of record and familiarity with VAT strategies.
• Required: Understanding of CGMP and CGCP requirements, compendia testing, and ICH and regulatory guidelines including stability data requirements.
• Required: Demonstrated ability to collaborate in a cross-functional environment.
• Required: Strong experience in project management best practices.
• Required: Excellent interpersonal and communication skills (written and oral) and ability to present data to peers, management, external partners, and investigators/site personnel.
• Preferred: Experience with preparation of regulatory documents.
• Required: Ability to work in a goal- and team-oriented setting and manage competing priorities.
• Required: Flexibility in a rapidly changing environment and high attention to detail.
• Required: Well-developed organizational skills and ability to thrive under pressure.
• Required: Well-versed in industry trends and emerging business processes and technologies.

Additional Requirements

• Travel: Up to 20% of time may be required.
• Physical Demands: Sit at a desk for extended periods; some walking and lifting up to 25 lbs may be required; able to use a keyboard and communicate effectively.
• Environment: Laboratory and controlled environments may apply where applicable.