Who are we?
Acceleron is a biopharmaceutical company dedicated to the discovery, development, and commercialization of therapeutics to treat serious and rare diseases. The Company's leadership in the understanding of TGF-beta superfamily biology and protein engineering generates innovative compounds that engage the body's ability to regulate cellular growth and repair.
Acceleron focuses its research and development efforts in hematologic, neuromuscular, and pulmonary diseases. In hematology, the Company and its global collaboration partner, Celgene, are co-promoting newly approved REBLOZYL® (luspatercept-aamt) in North America for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell transfusions and developing luspatercept for the treatment of chronic anemia in myelodysplastic syndromes and myelofibrosis. Acceleron is also advancing its neuromuscular program with ACE-083, a locally-acting Myostatin+ agent in Phase 2 development in Charcot-Marie-Tooth disease and is conducting a Phase 2 pulmonary program with sotatercept in pulmonary arterial hypertension.
What’s in it for you?
We are seeking an experienced and talented individual who thrives in a dynamic, fast-paced, team-oriented and collaborative environment. In this role, you will manage all aspects of the clinical drug supply chain, including creation, execution and maintenance of the clinical drug supply strategy and associated budget management. You will collaborate closely with the internal clinical supply chain team, cross-functional team members and CMO/CRO/IRT vendors. As the Clinical Supply Manager (CSM), you will manage drug product manufacture and label/pack/distribution at multiple CMOs and IRT system development/maintenance with vendors to ensure uninterrupted drug supply for global clinical trials.
What will you be doing?
- Manage supply chain CMOs to develop labeling/packaging materials, development of compliant country label text and the manufacture, storage and cold chain distribution of clinical trial materials via primary and secondary depots.
- Design IRT systems for new protocols and maintenance of existing ones, managing threshold levels, generation of manual shipments and disposition of quarantined materials, as needed. Organize UAT testing of IRT systems at kick off and system enhancements needed based on protocol changes
- Management of multiple IRT vendors/systems working as primary contact from an operational perspective. Developing the system to match the needs of internal cross-functional groups for proper data collection representing Clinical Operations, Data Management, Biostatistics, Safety and Quality, acting as the single point of contact on behalf of the internal teams
- Identify, evaluate, request proposals, possibly audit and select appropriate Contract Manufacturing Organizations and IRT vendors to meet Acceleron Business needs
What are we looking for?
- B.S./M.S. in a scientific field-Additional Project Management Training (PMP) would be beneficial
- Seven (7+) years of experience in managing Phase 1-Phase 3 global clinical supply chain in the Pharmaceutical and/or Biotech industry, either as a sponsor, vendor or CRO.
- Experience with combination drug products (drug + device) and commercial Supply Chains in various global markets.
- Experience managing vendors with strong understanding of regulatory requirements and guidelines governing labeling, packaging and distribution of clinical trial materials US/EU/ROW/Japan and Global country requirements (FDA/EMA/ICH)
- Knowledge of proper GMP/GXP trial documentation and identify what is required to be stored in the Trial Master File (TMF) regarding Supply Chain documents
- Cold chain product management, experience with forecasting tools, deep understanding of GMP/GXP requirements and development/implementation of sponsor internal processes & SOP’s for greater compliance and efficiencies are a plus
- Ability to strategically plan, organize and manage multiple projects simultaneously
- Ability to prioritize tasks/issues and identify them in the future, raising awareness to potential issues in a proactive manner. Strong work ethic to meet deadlines and be flexible on the potential occasion you may need to work outside of immediate job role or normal job hours to get the task done and meet the deadline.
- Ability to creatively solve Supply Chain issues
- Big picture understanding of the complete Drug Supply Chain: Drug Substance/Drug Product/Regulatory Submissions and steps required for compliant Drug Release approvals and Global Importation logistics process
- Strong interpersonal and organizational communication skills, including planning and execution of meetings and presentations. Effective listening, evaluation of issues and communication of mitigations. Professional, honest, accountable, dedicated
- Proficiency in all aspects of Microsoft applications (Excel, Word, PowerPoint, Project, etc.), experience with automated inventory systems, forecasting software and Oracle Inventory is a plus
- Ability to work full-time, on-site during core corporate hours at the Acceleron offices in Cambridge.
How will you grow with us?
This position will allow for growth within the role and the company, contributing your valuable experience in establishing Policies and Procedures for the Supply Chain Department during a critical time. With key regulatory milestones approaching for its lead product candidate, and other pipeline assets advancing in the clinic, Acceleron is entering one of the most exciting periods in its history. You will work closely with many cross-functional areas and will be able to contribute to their practices for a more efficient, cost effective and compliant Supply Chain. Our fast-paced environment and hands-on opportunity will challenge you to innovate and learn while having fun with supportive and passionate colleagues. Join our team!
*In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and complete the required employment eligibility verification document form upon hire.