Director, Clinical Supply

Job Description:

The Director, Clinical Supply is accountable for the end-to-end operational execution of clinical supply activities across assigned global studies. This role ensures that clinical trial material, including investigational product and ancillary supplies, is packaged, labeled, released, and available on time to meet program timelines and country startup requirements. The Director leads vendor negotiations, oversees inventory and demand planning, manages labeling and expiry updates, and ensures supply documentation is complete, compliant, and inspection ready.

This position partners cross functionally with Clinical Operations, Regulatory Affairs, Quality, and CMC, and works closely with external CDMOs and service providers. Clinical supply strategy is established by the Clinical Supply Strategic Lead; this role provides operational input and executes the agreed strategy with excellence.

The ideal candidate is a collaborative, solutions-oriented leader who thrives in a fast paced, dynamic environment and brings strong judgment, proactive risk management, and a commitment to operational excellence. This role reports to the Senior Director, Global Supply Chain.

Key Responsibilities:

Clinical Supply Execution

• Lead day-to-day clinical supply operations for assigned studies, including timeline management, deliverables, and issue escalation/resolution.
• Translate protocol requirements, enrollment assumptions, and country needs into robust supply execution plans.
• Proactively identify and mitigate supply risks, ensuring continuity and compliance across all participating regions.

Vendor Sourcing & Management

• Lead competitive sourcing, quote evaluation, and commercial negotiations to support budget planning and approvals.
• Serve as the primary operational interface with packaging/labeling vendors, CDMOs, and external service providers; manage performance against scope, schedule, and quality expectations.
• Drive accountability with vendors through clear governance, metrics, and routine business reviews.

Packaging, Labeling & Expiry Management

• Oversee execution of packaging and labeling operations, including secondary packaging, rework activities, and de-bottling when required.
• Coordinate label content development and translation workflows with Clinical and Regulatory, ensuring alignment with country-specific requirements.
• Monitor product expiry, stability-driven updates, and retest needs; coordinate updates with CDMOs and ensure implementation across all depots.

Regulatory & Quality Readiness

• Partner with Regulatory to ensure required CMC and operational documentation is available to support study start‑up and country submissions.
• Ensure supply configurations, distribution plans, and operational approaches are documented and ready for Quality/Technical endorsement.
• Support QP release requirements and ensure all documentation is complete, accurate, and compliant.

Documentation Management

• Compile, maintain, and organize supply documentation packages, including batch records, packaging records, product specification files, QP documentation, and CDMO deliverables.
• Ensure version control, traceability, and inspection readiness across all supply documentation.

Governance & Cross Functional Communication

• Lead internal clinical supply meetings, driving clarity on status, risks, decisions, and action items.
• Represent clinical supply in cross functional and vendor/CDMO meetings; ensure timely issue resolution and appropriate escalation.
• Communicate proactively with program teams to maintain alignment on supply strategies, changes, and constraints.

Requirements:

• Bachelor’s degree in a scientific, engineering, or related discipline; advanced degree preferred.
• 10+ years’ experience in clinical supply execution and operations, including global study support and vendor management.
• Strong working knowledge of clinical packaging/labeling operations, translation workflows, and country-specific labeling requirements.
• Experience preparing or managing supply-related documentation for Quality, Regulatory, and QP review.
• Experience with QP release support processes and documentation expectations, where applicable.
• Demonstrated experience managing clinical inventory across multiple studies/indications and developing operational tracking/forecasting tools.
• Exceptional meeting facilitation and project management skills, including agendas, minutes, action tracking, and risk logs.
• Proven ability to influence and collaborate across functions and drive alignment under a unified operational strategy.
• Strong analytical skills with the ability to interpret data, anticipate trends, and make data-informed decisions.
• Excellent written and verbal communication skills with the ability to engage stakeholders at all levels.
• Ability to manage multiple projects simultaneously with strong organization and prioritization skills.
• Demonstrated ability to anticipate challenges, develop proactive solutions, and navigate ambiguity.
• Proficiency with Microsoft Office and relevant supply chain systems/tools.
• Ability to travel as required to support business priorities.
• Remote position: Northeast U.S. preferred.

Salary and Benefits:

We offer a competitive base salary, annual bonus, and long-term incentives. In addition, we provide a comprehensive benefits package, including health insurance, dental and vision coverage, term life and disability coverage, and retirement plans.

NewAmsterdam Pharma is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information, or any other basis protected by federal, state or local law.