DescriptionAn exciting opportunity to lead the strategic and operational management of complex clinical supply activities across all phases of development to provide life-changing therapeutics for patients. The Senior Director of Clinical Supply Chain ensures the uninterrupted, compliant, and cost-effective delivery of investigational products to global clinical trial sites. The ideal candidate will bring deep expertise in supply chain strategy, vendor oversight, and cross-functional collaboration, with a strong understanding of GMP, IRT systems, and regulatory requirements.
ResponsibilitiesStrategic Leadership
- Develop and execute global clinical supply chain strategies aligned with corporate and clinical development goals.
- Lead long-range planning and drive the continued development and transformation of supply chain infrastructure to meet the needs of the growing business.
- Partner with Legal, Finance, Trade Compliance, Quality Assurance, Regulatory Affairs, Clinical Operations, CMC Teams, and other functions across the internal network, to deliver responsibilities aligned with business goals.
Operational Oversight
- Oversee demand forecasting, inventory management, and supply planning using simulation tools.
- Manage packaging, labeling, distribution, and returns of clinical trial materials (CTM) in compliance with GMP and global regulations.
- Lead IRT system design, implementation, and user acceptance testing for effective drug tracking and randomization.
Vendor and Budget Management
- Lead senior level business relationship management with CMOs and third-party logistics providers; develop and ensure adherence to contracts and KPIs.
- Collaborate with Quality Assurance leadership on vendor qualification and audits.
- Develop and manage clinical supply budgets, ensuring cost-effective operations.
- Partner with program project managers to align clinical supply budgets with overall program financial planning and ensure transparency in forecasting, tracking, and reporting.
Compliance and Inspection Readiness
- Ensure inspection readiness for global regulatory audits.
- Maintain documentation and SOPs to support compliance and continuous improvement.
Team Leadership
- Mentor and continue to build a high-performing clinical supply chain team.
- Foster a culture of accountability, innovation, and cross-functional collaboration. Strategic Leadership.
QualificationsQualifications
- Bachelor’s degree in Life Sciences, Pharmacy, Supply Chain, or related field (advanced degree preferred).
- 15+ years of experience in clinical supply chain management within the pharmaceutical or biotech industry.
- Proven leadership in global clinical supply operations, including late-stage and commercial transition.
- Strong knowledge of GMP, IRT systems, and regulatory requirements.
- Excellent communication, project management, and vendor negotiation skills.
Alkermes has recently adopted a hybrid working environment to support and meet the needs of employees and this role will operate in a flexible environment with 60% of time in the office and 40% from home. This position is eligible for the hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office at least 3 days per week. This role is not eligible for fully remote.
The annual base salary for this position ranges from $255,000 to $270,000. In addition, this position is eligible for an annual performance pay bonus. Exact compensation may vary based on skills, training, knowledge, and experience. Alkermes offers a competitive benefits package. Additional details can be found on our careers website: www.alkermes.com/careers#working-here
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