Associate Director, Clinical Supply Chain

Accountabilities:: Translate clinical trial assumptions into drug forecasts, supply plans, and distribution strategies, ensuring 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. Benefits: Expected salary range of $170,000–$204,750, depending on skills, competency, and market demand. 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.