Director, Clinical Supply Chain Operations
The Director of Clinical Supply Chain Operations is responsible for leading global demand planning and ensuring the successful delivery of Investigational Material(s) for patients on Insmed therapies. This role involves developing and executing strategic plans for production, packaging, distribution, and clinical supply budgeting. The Director provides strategic leadership for Clinical Supply Chain & Logistics operations across all clinical programs and plays a key role on the Clinical Supply Chain & Logistics Leadership Team. What You'll Do:
- Develop, coordinate and manage execution of all clinical supply activities including demand/production planning, clinical packaging (primary/secondary), labeling, distribution, returns, reconciliation, destruction, and logistics for global clinical programs
- Define and implement comprehensive sourcing strategies, engaging CMOs, CROs, 3PLs, IXRS/IRT vendors and other third-party providers in alignment with clinical development and Clinical Operations timelines
- Foster and manage strategic supplier relationships, lead vendor selection, performance monitoring, business review governance, and continuous improvement reviews
- Establish and maintain KPIs, scorecards, and governance frameworks for both internal supply operations and external partners
- Serve as clinical supply representative on cross-functional project and clinical strategy teams; translate protocol design into demand/supply plans, contingency strategies, and risk mitigation across global markets
- Support the development and monitoring of clinical supply budgets and global financial forecasts (e.g. comparators, manufacturing demand, packaging & labeling production and distribution)
- Mentor and manage Clinical Supply managers or direct reports; build operational structure and foster career/talent development
- Create, review, and update SOPs, pharmacy manuals, Investigator Brochures, and handling guidance
- Support Clinical Supply Chain to ensure compliance with eTMF documentation and audit readiness activities
- Support regulatory filings (IND/CTA/IMPD), act as SME during inspections, perform risk assessments for supply interruptions and implement and complete mitigation strategies
- Collaborate on system design, UAT testing, maintenance, to ensure robust supply tracking and randomization support
- Collaborate with CMC, Clinical Ops, Quality, Regulatory, and Commercial Supply teams to align clinical supply efforts with broader D&OP / S&OP and processes and commercial readiness
- Support Clinical Supply Chain digital transformation (e.g., forecasting tools, dashboards, AI-driven analytics), drive process optimization, resilience, sustainability, and operational excellence
- Oversee global depot inventory, labeling strategies, temperature excursion management, import/export logistics, and ensuring patient supply continuity
- Bachelor's Degree in science or business related field ; Masters/MBA in Operations preferred.
- Minimum 10 years of experience handling / leading clinical supply chain and logistics; some development experience preferred.
- Ability to rapidly navigate the organization and identify, align, and integrate cross-functional resources into cohesive teams
- Demonstrated ability to work in a highly matrixed environment is essential; ability to develop and lead a high performing team across all levels
- Experience in multi-functional areas (Clinical, Regulatory, Quality) demonstrating a broad understanding of pharmaceutical development!
- Expert knowledge of all phases of drug development, of the functions and processes relevant to drug development, and project management principles applicable to the biopharmaceutical environment!
- Extensive experience in planning and execution of investigational materials supply strategies
$171,000.00-239,667.00 Annual Life at Insmed At Insmed, you'll find a culture as human as our mission-intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself. Highlights of our U.S. offerings include:
- Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
- Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
- 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
- Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
- Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back
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