Associate Director, Clinical Supply Chain

About the role

Associate Director, Clinical Supply Chain based in the United States, leading end-to-end clinical supply chain activities for a global clinical-stage portfolio.

Responsibilities

• Translate clinical trial assumptions into drug forecasts, supply plans, and distribution strategies to ensure continuous investigational product availability from first patient in through trial completion.
• Lead end-to-end clinical supply execution and provide supply chain leadership to clinical study teams across programs approaching key milestones.
• Serve as a standing member of CMC and Study Management Teams and act as a key liaison with Clinical Operations, Vendor Management, Quality, Regulatory, and external partners.
• Act as the primary interface for strategic clinical supply matters involving finished drug product and related supply requirements.
• Develop and maintain clinical supply project plans, detailed study forecasts, schedules, dependencies, and execution timelines using input from Clinical, CMC, Regulatory, and contract providers.
• Manage clinical supply budgets and ensure accurate and timely payment of contract manufacturing organization invoices.
• Plan and oversee secondary packaging, labeling, and final drug release activities, including label generation, regulatory adaptations, translations, and vendor approvals.
• Provide supply-related input to RTSM requirements, conduct user acceptance testing, and oversee ongoing system maintenance for supply-related changes.
• Proactively identify and mitigate end-to-end supply chain risks, including country backups, inventory levels, shelf life, and other continuity considerations.
• Partner with Clinical Operations, Quality Assurance, and Regulatory teams to develop kits and country-specific label text and support IND, IMPD, and CTA submissions as required.
• Manage quality-system documentation, including deviations, investigations, CAPAs, change controls, product specifications, and label specifications.
• Ensure clinical supply documentation is appropriately maintained for Trial Master Files, Clinical Study Reports, and other study records.
• Track project commitments and proactively follow up on activities to ensure clinical supply milestones and deliverables remain on schedule.

Requirements

• 10+ years of relevant experience with a Bachelor's degree, or 8+ years of experience with a post-graduate degree.
• Demonstrated clinical supply chain experience, with additional exposure to Manufacturing, Quality, and/or Regulatory functions preferred.
• Strong knowledge of global clinical trials, the drug development lifecycle, and clinical supply chain processes, systems, metrics, and best practices.
• Experience working in GxP environments with an understanding of global pharmaceutical regulations, including cGMP, GCP, 21 CFR Part 11, and Annex 13.
• Proven ability to build strategic relationships and collaborate effectively with Clinical Operations, Quality, CMC, Regulatory, contract manufacturers, logistics providers, and other stakeholders.
• Strong experience managing external supply partners and functions such as packaging, labeling, distribution, depots, and logistics.
• Highly developed influencing, persuasion, negotiation, and stakeholder management skills, with the ability to build consensus across a matrixed organization.
• Excellent communication, organizational, problem-solving, and project management skills, with strong attention to detail and the ability to respond quickly to emerging issues.
• Comfortable operating in a fast-paced, highly collaborative environment and adapting to changing priorities and differing perspectives.
• Innovative and team-oriented mindset, with a strong commitment to collaboration and shared success.
• Expert proficiency in Microsoft Excel and PowerPoint, with strong experience using project planning tools such as Microsoft Project and Office Timeline.

Pay

Expected salary range of $170,000–$204,750, depending on skills, competency, and market demand.

Benefits

• Bonus and equity compensation.
• 401(k) plan with company matching.
• Medical insurance with 95% of premiums covered.
• Dental and vision insurance with 100% of premiums covered.
• Mental health and wellness benefits.
• Weeklong summer and winter holiday shutdowns.
• Generous paid time off and holiday policies.
• Life and AD&D insurance with premiums fully covered, plus optional supplemental coverage.
• Enhanced parental leave.
• Daily subsidized lunch program when working on-site.