Senior Director, Clinical Supply Chain

5 days ago

Cambridge MA United States Alnylam Pharmaceuticals Full time
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This role is considered Hybrid.

Overview

The Senior Director, Clinical Supply Chain will lead all aspects of clinical supply chain management, ensuring that investigational products are delivered on time, in compliance, and aligned with global clinical trial requirements. This role involves strategic oversight of supply planning, manufacturing, vendor management, and logistics, with a focus on innovation, efficiency, and risk mitigation. The Senior Director will manage a high-performing team and serve as a key partner across internal and external stakeholders to support company goals.

This position is hybrid and will be primarily located at Alnylam offices in Cambridge, MA. The hybrid work expectation for this role is that the person hired will work in the office a minimum of two days per week.

Key Responsibilities

Strategic Leadership

  • Develop and lead clinical supply chain strategies to support global clinical trials, aligning with clinical, regulatory, and corporate goals.
  • Build and communicate a vision for an efficient, scalable clinical supply chain process that supports early- and late-stage clinical trials for a growing pipeline.
  • Drive cross-functional collaboration with Clinical Operations, Quality, Regulatory Affairs, Manufacturing, and other internal & external stakeholders.
  • Partner with Clinical Operations to align on demand assumptions throughout entirety of studies

Operational and Technical Oversight

  • Clinical Manufacturing: Oversee packaging and labeling activities for clinical trial materials in compliance with Good Manufacturing Practices (GMP).
  • IRT and Systems Management: Lead the development, implementation, and user acceptance testing (UAT) for IRT systems, ensuring effective tracking, randomization, and inventory management.
  • N-SIDE Integration: Utilize N-SIDE suite to optimize clinical supply planning and decision-making, including demand forecasting, simulation, risk assessment, and resource allocation
  • Labeling: Oversee the creation and approval of clinical supply labeling, including translations and compliance with country-specific regulations.
  • Inventory and Returns: Oversee site and depot returns, destruction of clinical trial materials, and reconciliation of inventory for trial closeout.

Vendor and Supplier Management

  • Oversee performance and delivery from Contract Manufacturing Organizations (CMOs) and other suppliers, ensuring adherence to Service Level Agreements (SLAs) and Key Performance Indicators (KPIs).
  • Develop and maintain strong vendor relationships to ensure continuity of supply and innovation in processes.

Regulatory and Compliance

  • Ensure inspection readiness for regulatory audits, preparing documentation and collaborating with cross-functional teams to address compliance issues.
  • Responsible for management, compliance, and oversight of eTMF sections
  • Oversee compliance with GxP standards, including GMP, GDP, and GCP, across all clinical supply activities.

Financial and Risk Management

  • Prepare and manage clinical supply budgets at both program and protocol levels, leveraging tools like Smartsheets and financial planning software.
  • Identify potential risks to the supply chain and develop proactive mitigation strategies to ensure uninterrupted supply.

Team Development and Leadership

  • Lead, mentor, and develop a team of Clinical Supply Chain professionals, fostering career growth and creating a culture of accountability and excellence.
  • Implement development opportunities and individual growth plans to support team expansion and pipeline needs.

Qualifications

Education: Bachelor's degree in Supply Chain Management, Life Sciences, Pharmacy, or a related field (advanced degree preferred).

Experience:

  • Minimum of 15+ years of direct experience in clinical supply chain management.
  • Proven track record of leading global clinical supply operations in the biopharmaceutical industry.

Technical Skills:

  • Proficiency in systems such as IRT, Veeva (or equivalent quality docs), and eTMF.
  • Strong understanding of regulatory and compliance frameworks (GMP, GDP, GCP).

Leadership Skills:

  • Demonstrated ability to lead cross-functional teams, manage complex projects, and inspire high performance.
  • Excellent communication, collaboration, and problem-solving skills.

About Alnylam:Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by "interfering" with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.

Our culture:Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we've been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as the #1 Large Employer by Boston Globe Top Places to Work in 2023 for the third consecutive year, one of Science Magazine's Top Biopharma Employers, one of America's Most Responsible Companies for 2024 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK - among others.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients. Qualified applicants will receive consideration for employment without regard to their race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, ethnicity, marital status, protected veteran status, disability, or any other characteristics prohibited by law.

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