Associate Director, Supply Chain
2 weeks ago
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 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 2022, one of Science Magazine’s Top Biopharma Employers, one of America's Most Responsible Companies for 2023 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. Alnylam is an E-Verify employer.
-
Supply Chain Planner
2 weeks ago
Cambridge, United States ZDA, LLC Supply Chain Recruiting Full timeGrowing R&D Research Company seeking talented Supply Chain Buyer/Planner, that will be responsible for navigating complex supply chain support and business strategies with suppliers including ensuring right quality, and quantity is purchased for the companies needs. This role will reduce risk by identifying and mitigating potential supplier issues, shortages...
-
Supply Chain Planner
4 weeks ago
Cambridge, United States ZDA, LLC Supply Chain Recruiting Full timeGrowing R&D Research Company seeking talented Supply Chain Buyer/Planner, that will be responsible for navigating complex supply chain support and business strategies with suppliers including ensuring right quality, and quantity is purchased for the companies needs. This role will reduce risk by identifying and mitigating potential supplier issues, shortages...
-
Supply Chain Planner
2 weeks ago
Cambridge, United States ZDA, LLC Supply Chain Recruiting Full timeGrowing R&D Research Company seeking talented Supply Chain Buyer/Planner, that will be responsible for navigating complex supply chain support and business strategies with suppliers including ensuring right quality, and quantity is purchased for the companies needs. This role will reduce risk by identifying and mitigating potential supplier issues, shortages...
-
Supply Chain Operations Director
4 weeks ago
Cambridge, United States Philips Full timeJob Title Supply Chain Operations Director Job Description Supply Chain Operations Director has responsibility for operations at key contract manufacturing partners in the S&RC (Sleep & Respiratory Care devices) supply chain, including accountability for all aspects of operational performance. In this role, you are responsible for: - Overseeing operations...
-
Supply Chain Operations Director
1 month ago
Cambridge, United States Philips Iberica SAU Full timeJob Title Supply Chain Operations Director Job Description Supply Chain Operations Director has responsibility for operations at key contract manufacturing partners in the S&RC (Sleep & Respiratory Care devices) supply chain, including accountability for all aspects of operational performance. In this role, you are responsible for: - Overseeing operations...
-
Supply Chain Operations Director
2 weeks ago
Cambridge, United States Philips Iberica SAU Full timeJob Title Supply Chain Operations Director Job Description Supply Chain Operations Director has responsibility for operations at key contract manufacturing partners in the S&RC (Sleep & Respiratory Care devices) supply chain, including accountability for all aspects of operational performance. In this role, you are responsible for: - Overseeing operations...
-
Supply Chain Operations Director
2 weeks ago
Cambridge, United States Philips Full timeJob Title Supply Chain Operations Director Job Description Supply Chain Operations Director has responsibility for operations at key contract manufacturing partners in the S&RC (Sleep & Respiratory Care devices) supply chain, including accountability for all aspects of operational performance. In this role, you are responsible for: - Overseeing operations...
-
Senior Director, Supply Chain
4 days ago
Cambridge, United States Editas Medicine Full timeAt Editas, we're driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing. We believe our people are at...
-
Senior Director, Supply Chain
4 weeks ago
Cambridge, United States Editas Medicine Full timeJob DescriptionJob DescriptionAt Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing....
-
Senior Director, Supply Chain
3 weeks ago
Cambridge, United States Editas Medicine Full timeAt Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing. We believe our people are at...
-
Senior Director, Supply Chain
1 week ago
Cambridge, United States Editas Medicine Full timeJob DescriptionJob DescriptionAt Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing....
-
Supply Chain Operations Director
1 month ago
Cambridge, Massachusetts, United States Philips Full timeJob TitleSupply Chain Operations DirectorJob DescriptionSupply Chain Operations Director has responsibility for operations at key contract manufacturing partners in the S&RC (Sleep & Respiratory Care devices) supply chain, including accountability for all aspects of operational performance.In this role, you are responsible for: - Overseeing operations with...
-
Supply Chain Manager
2 weeks ago
Cambridge, United States International Staff Consulting Full timeWe are hiring a Supply Chain Manager to lead a team of Supplier Management and Small Business professionals and serve as the Supply Chain ERP implementation advisor for this Defense Contractor. Reporting to the Director of Procurement & Property, the Supply Chain Manager will support the supply chain needs of the program offices. This is a senior level role...
-
Director, Clinical Supply Chain
1 month ago
Cambridge, United States QurAlis Full timeABOUT THE COMPANY QurAlis is a clinical-stage biotechnology company developing breakthrough precision medicines for amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases with genetically validated targets. QurAlis is trailblazing the path to conquering amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases with...
-
Supply Chain Manager
3 weeks ago
Cambridge, United States Verve, Inc. Full timeVerve is building a world-class team to commercialize wearable solutions that empower the way people move in the world. Our first product is a lightweight, connected wearable system that can be worn all day, every day by industry associates to improve worker safety, and experience. Verve is growing and launching partnerships with some of the leading...
-
Supply Chain Manager
3 days ago
Cambridge, United States Verve Full timeVerve is building a world-class team to commercialize wearable solutions that empower theway people move in the world. Our first product is a lightweight, connected wearable systemthat can be worn all day, every day by industry associates to improve worker safety, andexperience. Verve is growing and launching partnerships with some of the leading companies...
-
Supply Chain Manager
2 weeks ago
Cambridge, United States Verve, Inc. Full timeJob DescriptionJob DescriptionVerve is building a world-class team to commercialize wearable solutions that empower theway people move in the world. Our first product is a lightweight, connected wearable systemthat can be worn all day, every day by industry associates to improve worker safety, andexperience. Verve is growing and launching partnerships with...
-
Supply Chain Manager
3 weeks ago
Cambridge, United States Verve, Inc. Full timeJob DescriptionJob DescriptionVerve is building a world-class team to commercialize wearable solutions that empower theway people move in the world. Our first product is a lightweight, connected wearable systemthat can be worn all day, every day by industry associates to improve worker safety, andexperience. Verve is growing and launching partnerships with...
-
Supply Chain Manager
3 days ago
Cambridge, United States Verve Full timeVerve is building a world-class team to commercialize wearable solutions that empower the way people move in the world. Our first product is a lightweight, connected wearable system that can be worn all day, every day by industry associates to improve worker safety, and experience. Verve is growing and launching partnerships with some of the leading...
-
Supply Chain Specialist
4 days ago
Cambridge, United States Planet Professional Full timeClinical Supply Chain PlannerContractHybrid-2 days a week onsite6 monthsStart 6/25 (that is a set onboarding date)Process: video interviewIndustry: Biotech, public company, 2000 employees, company growing (have commercial productsHours: full-timeLocation: Third St. Cambridge, MA (Kendall Square)WFH situation: Hybrid (2 days per week onsite)Background check:...
