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Associate Director, Clinical Supply Chain

1 month ago

Boston, United States Alnylam Full time

This role is considered Hybrid.

Overview

This position is responsible for the management and oversight of end to end clinical supply chain activity for assigned clinical protocols. This position works closely with key stake holders including Clinical Operations, Global Planning, Quality Assurance, Regulatory Affairs, Contract Manufacturing Operations (CMO's), and Contract Research Operations (CRO's) to ensure seamless supply of Clinical Trial Material. Some key areas of management/oversight include forecasting, packaging, labeling, distribution, inventory management, financial planning/ budgeting, vendor oversight, and eTMF filing of Clinical Supply documents. A successful candidate will be skilled at understanding the Clinical Supply needs and responsibilities, exhibit strong attention to detail, support a collaborative environment, and strong ability to manage workload and meet project timelines.

Key Responsibilities

  • Key responsibilities include oversight, mentoring, & management of Clinical Supply Chain (CSC) staff, clinical programs (early& late-stage), GXP & technology forecasting systems, and engagement with CMO suppliers.
  • Knowledge base includes solid experience and understanding of end-to-end clinical supply chain activities, systems knowledge (IRT, forecasting, planning, and simulation), and supplier management systems and strategy.
  • Oversight & review clinical trial documents and understand/ communicate the impact on clinical supply (eg. Protocol, pharmacy manual, etc)
  • Preparation and delivery of inspection ready documents for late-stage programs and regulatory inspections, as they relate to the programs responsible for.
  • Collaborate with cross functional internal team and external vendors to identify and address any activity that impacts clinical supply and the delivery of medicine to patients
  • Manage finished goods planning, packaging, labeling, storage and distribution of clinical trial material for global clinical trials and ensure seamless supply to patients
  • Manage & monitor inventory levels at depots and clinical sites and take preventative actions to avoid potential supply issues
  • Responsible for IRT (Interactive Response Technology) development, user acceptance testing (UAT), and system oversight and management related to Clinical Supply
  • Prepare and manage budget across assigned protocols and/or programs utilizing budget, planning, and allocation tools
  • Partner with Clinical Operations to align on demand assumptions throughout entirety of studies
  • Create, monitor, and update clinical supply packaging and labeling plans and supply strategies to maximize efficiency, minimize waste, and accommodate ongoing updates to actual activity and overall team strategy
  • Design and actively manage supply & demand forecasts with optimization tool
  • Identify & mitigate potential supply risks, and develop risk mitigation plans as necessary
  • Drive label creation and approval process, including translations and regulatory requirements
  • Communicate clinical supply demand requirements to Global Planning (throughout entirety of protocol) and ensure seamless coordination of demand and supply
  • Manage & oversee site & depot returns and destruction of clinical trial material for assigned protocols and/or programs, and respective close out reports.
  • Manage program and/or protocol budget, monitor Key Performance Indicators (KPIs), and strive to achieve relevant cost saving targets
  • Manage and/or oversee temperature excursions during transportation on assigned study
  • Responsible for management, compliance, and oversight of eTMF sections under CSC responsibility
  • Opportunity to develop team, mentoring and managing staff with growing team & pipeline
  • Opportunity to contribute to supplier relationship and management of performance, oversight, and delivery across finished goods suppliers.
Qualifications
  • BS degree in Sciences or Supply Chain Management. Pharmacy degrees also encouraged to apply
  • Minimum 10 years of direct Clinical Supply Chain experience
  • Demonstrated experience in clinical supply management globally
  • Strong understanding of GxP (including, but not limited to GMP, GDP, and GCP)
  • Proficient knowledge of Veeva, eTMF management, Smartsheets, Visio, MS Office (Excel, PowerPoint, Visio, Project, etc)
  • Demonstrated flexibility to adapt to external environment influences through identifying new strategies and tactics
  • Strong attention to detail
  • Excellent communication, collaboration, mentoring, and influencing skills
  • Ability to multi-task and manage complex challenges & risk mitigation proactively

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 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.