Associate Director, Clinical Supply Chain

hace 1 mes


Puerto Diablo, Puerto Rico Alnylam A tiempo completo

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.



  • Puerto Diablo Barrio, Puerto Rico Jobleads-Us A tiempo completo

    Job Title: Associate Director, Clinical Supply Chain PlanningCompany Overview: CRISPR Therapeutics is a pioneering biotechnology company that has transformed the field of gene editing. With a diverse portfolio of product candidates across various disease areas, we are committed to creating a new class of transformative medicines.Position Summary:We are...


  • Puerto Diablo, Puerto Rico Jobleads-Us A tiempo completo

    Company Overview Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare...


  • Puerto Diablo Barrio, Puerto Rico Jobleads-Us A tiempo completo

    Company OverviewCRISPR Therapeutics is a pioneering biotechnology company that has transformed the field of gene editing. With a diverse portfolio of product candidates across various disease areas, the company is committed to creating a new class of potentially transformative medicines. To accelerate its efforts, CRISPR Therapeutics has established...


  • Puerto Diablo Barrio, Puerto Rico Jobleads-Us A tiempo completo

    Job Title: Clinical Supply Chain Planning DirectorCompany Overview: CRISPR Therapeutics is a leading biotechnology company that has transformed from a research-stage company to a diverse portfolio of product candidates across various disease areas. The company has established strategic partnerships with leading companies and has a presence in Zug,...


  • Puerto Diablo, Puerto Rico Jobleads-Us A tiempo completo

    Senior Manager/Associate Director, Supply Chain Planning Boston, MA, USA Req #305 Thursday, August 15, 2024 Who We Are: Who We Are: Xenon Pharmaceuticals (NASDAQ:XENE ) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological...


  • Puerto Diablo Barrio, Puerto Rico Chewy A tiempo completo

    Job Title: Associate Director, Instock ManagementChewy is seeking a highly motivated and results-driven Associate Director, Instock Management, to join our Chewy Vet Care team. This role is critical for leading the development and management of our supply chain operations, ensuring efficiency and accuracy across our network.Key Responsibilities:Lead a team...


  • Puerto Diablo Barrio, Puerto Rico Jobleads-Us A tiempo completo

    About Xenon PharmaceuticalsXenon Pharmaceuticals is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric disorders.Job SummaryWe are seeking a Senior Manager/Associate Director, Supply Chain Planning to join...


  • Puerto Diablo Barrio, Puerto Rico Jobleads-Us A tiempo completo

    **About the Role**We are seeking a highly skilled Director of Supply Chain Optimization to join our team at Jobleads-Us. As an Associate Director, Commercial Operations, you will be responsible for leading and managing a comprehensive Sales and Operations Planning process and meetings to review clinical/commercial demand and supply, alignment with...


  • Puerto Diablo Barrio, Puerto Rico Alnylam A tiempo completo

    About the RoleThis is a key leadership position responsible for the management and oversight of end-to-end clinical supply chain activities for assigned clinical protocols. The successful candidate will work closely with cross-functional teams, including Clinical Operations, Global Planning, Quality Assurance, Regulatory Affairs, Contract Manufacturing...


  • Puerto Diablo Barrio, Puerto Rico Jobleads-Us A tiempo completo

    About the RoleJobleads-Us is hiring a Strategic Supply Chain Director to be a Business Process Owner for Sales & Operations (S&OP) Planning process and responsible for managing end-to-end commercial process for cell & gene therapy.About YouYou'll help to bring more patients their bluebird days by:Leading and managing a comprehensive Sales and Operations...


  • Puerto Diablo Barrio, Puerto Rico Unitedhealth Group A tiempo completo

    Director of Procurement and Supply ChainAt UnitedHealth Group, we are committed to helping people live healthier lives and making the health system work better for everyone. As a Director of Procurement and Supply Chain, you will play a critical role in driving our mission forward.Key Responsibilities:Develop and implement procurement and supply chain...


  • Puerto Diablo Barrio, Puerto Rico Jobleads-Us A tiempo completo

    Job SummaryJobleads-Us is seeking a highly skilled Pharmacy Supply Chain Manager to join our team. The ideal candidate will have expertise in managing centralized and decentralized Supply Chain Management systems, as well as experience using integrated Electronic Health Record (EHR) systems. The selected candidate will be responsible for overseeing contract...


  • Puerto Diablo, Puerto Rico Jobleads-Us A tiempo completo

    Associate Director, Strategic Sourcing Supply Chain (Hybrid)Job Description The Strategic Sourcing Supply Chain lead will own Category Management activities across Vertex for distribution, logistics, and warehousing for complex supply chains involving small molecule, biologics, and Cell and Gene Therapy products. Working collaboratively with internal...


  • Puerto Diablo, Puerto Rico Jobleads-Us A tiempo completo

    Job Description - Pharmacy Supply Chain Manager (3304600)Reporting to the Director of Pharmacy Business and Finance, the Pharmacy Supply Chain Manager is responsible for the proper ordering, receipt, stocking, and issuing of all medications and supplies consumed by the main campus inpatient cost centers, the main campus outpatient cost centers, and the...


  • Puerto Diablo Barrio, Puerto Rico Jobleads-Us A tiempo completo

    {"# Job Title": "Supply Chain Manager H/F", "# Job Description": " Want to get involved in a fast-growing structure where professionalism, entrepreneurship, and enthusiasm meet? Good news: Citwell is looking for a Supply Chain Manager for its first international office in Boston.ManagerHere are 3 things that you should know about Citwell:1 – Citwell is a...

  • Supply Chain Strategist

    hace 4 semanas


    Puerto Diablo Barrio, Puerto Rico Jobleads-Us A tiempo completo

    Job Title: Supply Chain AdvAt Jobleads-Us, we're seeking a highly skilled Supply Chain Adv to join our team. As a key member of our organization, you will play a critical role in helping clients understand the health of their supply chains.Key Responsibilities:Analyze supply chain processes to identify and recommend changes.Analyze supply chain data and...


  • Puerto Diablo Barrio, Puerto Rico Jobleads-Us A tiempo completo

    Job Description:Job Title: Associate Director, Strategic Sourcing Supply ChainJob Summary:We are seeking a skilled Strategic Sourcing Leader for Global Supply Chain to join our team. As a key member of our supply chain organization, you will be responsible for leading category management activities across Vertex for distribution, logistics, and warehousing...


  • Puerto Diablo, Puerto Rico Us Tech Solutions A tiempo completo

    Job Description: Supply Chain Analyst (AmClienton Robotics Spares)As a Supply Chain Capacity Analyst you will:•Managing sales orders for multiple sites via Oracle EBS•Managing product lifecycle for multiple parts and communicating status to customers via Agile PLM•Partnering with procurement , finance, metering center teams for supply demand...


  • Puerto Diablo, Puerto Rico Us Tech Solutions, Inc. A tiempo completo

    Job Description: Supply Chain Analyst (AmClienton Robotics Spares)As a Supply Chain Capacity Analyst you will: Managing sales orders for multiple sites via Oracle EBS Managing product lifecycle for multiple parts and communicating status to customers via Agile PLM Partnering with procurement , finance, metering center teams for supply demand readiness...


  • Puerto Diablo Barrio, Puerto Rico Jobleads-Us A tiempo completo

    Job DescriptionJob Title: Pharmacy Supply Chain ManagerJob Summary:The Pharmacy Supply Chain Manager is responsible for overseeing the procurement, inventory management, and distribution of medications and supplies to ensure seamless operations within the pharmacy department. This role requires strong leadership and analytical skills to optimize supply chain...