This role is considered Virtual. **
Overview**
We are seeking an experienced individual for the role of Senior Manager, Clinical Supply Chain. In this position, you will play a pivotal role in ensuring the seamless operation of our clinical supply chain processes. Your focus will be on overseeing programs & staff within Clinical Supply Chain supporting Alnylam’s growing pipeline & patient needs. Collaboration with cross-functional teams such as Quality Assurance, Clinical Operations, CMC, Program Management, and Regulatory Affairs will be key as you manage the supply of essential materials to clinical sites globally, prioritizing patient needs in a dynamic environment. Overall, you'll be instrumental in managing inventory, mitigating risks, and ensuring program objectives are met effectively and efficiently.
This position is hybrid and will be primarily located in the Alnylam Cambridge office. **
Key Responsibilities**
- Responsible for planning, development, and execution of clinical supply chain activities for assigned clinical program(s) and/or protocol(s).
- Mentor and possibly manage CSC team members as needed on programs and systems.
- Responsible for clinical supply related activities for assigned program(s) and/or protocol(s) including, but not limited todevelopment of supply strategy using forecasting tools, IRT setup & management, inventory management, production, packaging, labeling, distribution, returns, destruction, and study closeout.
- Ensure all program goals and objectives are met on time & then monitored across the course of the study, and in full from a clinical supplies perspective (e.g. FPI, SIV, IRT, OTIF shipments to patients)
- Support PAI for assigned program(s) and/or protocol(s) as well as all program(s) and protocol(s) from a program, procedure, & systems perspective.
- Ensure current systems & procedures are aligned with current regulations & industry standards.
- Responsible for the investment planning budget & corresponding long range planning for assigned programs.
- Engage with CMO, CRO, & key suppliers that support systems, production & distribution.
Qualifications
- B.Sc. in a scientific field or Supply Chain Management. Pharmacy degrees are encouraged to apply
- 8+ years of direct Clinical Supply Chain experience globally
- Progressive knowledge of Import/export regulations, including pro-forma invoice generation, import regulations, and global trade compliance
- Proficient knowledge of MS Office (Excel, Smartsheet, PowerPoint, Visio, Project, etc)
- Experienced working with & managing third-party CMO clinical supply operations
- Strong experience of GxP & Systems including development of specifications, oversight of system operations, troubleshooting & identifying gaps, performing set-up & testing of systems, & understanding areas of limitations, risks, or gaps to mitigate (Forecasting/Planning, IRT, etc.)
- Excellent communication, attention to detail, collaboration, ability to manage complex challenges, and influencing 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.