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Kiniksa Pharmaceuticals
Lexington, MA, United States
About the job Reporting to the Director, Clinical Supply Chain the Manager, Clinical Supply Chain Management will be responsible for establishing and managing the end to end clinical supply for clinical studies/programs in various phases. Successful candidates will possess a fun, flexible, roll up your sleeves attitude, have the ability to work ind
Job Source: Kiniksa PharmaceuticalsKiniksa Pharmaceutical
Lexington, MA, United States
Reporting to the Director, Clinical Supply Chain the Manager, Clinical Supply Chain Management will be responsible for establishing and managing the end to end clinical supply for clinical studies/programs in various phases. Successful candidates will possess a fun, flexible, roll up your sleeves attitude, have the ability to work independently and
Job Source: Kiniksa PharmaceuticalLife Sciences Recruitment
Lexington, MA, United States
Location: Lexington office. Hybrid schedule: 4 days in-office, 1 day remote. As the Clinical Supply Chain Snr/Manager, under the Directors guidance, youll spearhead the setup and oversight of clinical supply chains for studies/programs spanning multiple phases. Were looking for proactive, adaptable individuals who excel in dynamic environments and
Job Source: Life Sciences RecruitmentAlkermes
Watertown, MA, United States
Job Description Position Summary: The Sr. Manager position within Clinical Supply Chain leads end-to-end supply chain management on single to multiple clinical programs as part of a growing, dynamic Pharmaceutical Development organization. They work closely as a key point of contact with Clinical Operations, Regulatory Affairs, Quality, Internal
Job Source: AlkermesAlkermes
Waltham, MA, United States
Job Description Position Summary: The Manager position within Clinical Supply Chain leads end-to-end supply chain management on single to multiple clinical programs as part of a growing, dynamic Pharmaceutical Development organization. They work closely as a key point of contact with Clinical Operations, Regulatory Affairs, Quality, Internal & Ex
Job Source: AlkermesKinsley Power Systems
Cambridge, MA, United States
Senior Manager, Clinical Supply Chain Who we are: Agios is a biopharmaceutical company that is fueled by connections. We thrive in a supportive, fun, and flexible environment full of people empowered to bring their whole selves to work. We care deeply about our work, each other, and the patients who count on us. Our teams cultivate strong bonds
Job Source: Kinsley Power SystemsLife Sciences Recruitment
Lexington, MA, United States
Location: Lexington office. Hybrid schedule: 4 days in-office, 1 day remote. As the Clinical Supply Chain Snr/Manager, under the Director's guidance, you'll spearhead the setup and oversight of clinical supply chains for studies/programs spanning multiple phases. We're looking for proactive, adaptable individuals who excel in dynamic environments
Job Source: Life Sciences RecruitmentCullinan Therapeutics
Cambridge, MA, United States
Cullinan Therapeutics, Inc.(Nasdaq: CGEM) is a biopharmaceutical company dedicated to creating new standards of care for patients. We have strategically built a diversified portfolio of clinical-stage assets that inhibit key drivers of disease or harness the immune system to eliminate diseased cells in both oncology and autoimmune disease. Our por
Job Source: Cullinan TherapeuticsWaltham, MA, United States
Syndax Pharmaceuticals is looking for a Manager, Clinical Supply Chain
At Syndax, we are determined to realize a future in which people with cancer live longer and better than ever before. Syndax Pharmaceuticals is a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies.
The Role:
The Manager of Clinical Supply Chain be responsible for managing investigational drug supplies for multiple worldwide oncology trials. They will oversee all aspects of clinical supply management including packaging, labeling, distribution, monitoring inventory, and vendor oversight. They will have an excellent understanding of the clinical supply packaging and labeling processes and be able to independently manage supply needs and distribution.
Key Responsibilities:
Develop clinical supply packaging and labeling to fulfill clinical study dosing requirements and patient compliance for Syndax’s Early Access Program, Compassionate Use, IST and Collaborative studies. Work with CMC, Clinical Operations, Quality Assurance, Medical Affairs, Regulatory Affairs, vendors, and others, as required, to finalize and implement designs.
Assess labeling, packaging and distribution needs on a study-by-study basis and identify appropriate vendors to conduct this work. Establish agreements with these vendors.
Manage outsourcing of labeling, packaging, storage, and distribution of Syndax-manufactured drug supply and co-administered supplies, as required, to global sites.
Translate clinical protocols into a supply forecast to determine the appropriate amounts of drug supply needed and schedule productions accordingly.
Monitor inventory levels at depots and advise clinical sites on inventory levels for non-IRT supported studies through the life of a trial; take preventive actions to avoid potential supply issues.
Collaborate with external vendors to develop and approve specifications and user acceptance testing of IRT systems, where these are utilized for supply management. Review and request modifications when study plans change.
Manage day-to-day orders of resupplies to sites for studies not supported with an IRT system.
Provide timely technical review of vendor-generated documentation and collaborate with Quality to complete final review/approvals, as required.
Establish practices and SOPs as needed, to support industry best practices.
Collaborate with Quality to establish and regularly review Quality Agreements with vendors and partners providing packaging, labeling and/or distribution services.
Collaborate with CMC, Quality, Regulatory and Clinical Operations, and others, as needed to assure joint success.
Manage end to end supply chain activities including accountability and reconciliation for global trials for both IRT and non-IRT trials.
Prevent and resolve operational issues such as deviations, corrective and preventative actions, production delays, etc.
Desired Experience/Education and Personal Attributes:
BS, MS or PharmD degree, and at least 5-7 years of clinical supply chain experience within pharma/biotech. APICS certification or coursework is desired.
Thorough understanding of GXPs governing the manufacture of pharmaceutical drug products and conduct of routine clinical trials distribution.
Extensive experience in clinical supply management including logistics (labeling, packaging, distribution, expiries), inventory tracking, and managing IRT systems.
Must be knowledgeable in US, EU, and ROW clinical supply labeling requirements and the QP review/release/certification process for European clinical supplies.
Experience with both ambient and cold chain products.
Must be able to effectively manage multiple activities and problem-solve to achieve business needs.
Strong communication skills, able to work independently and collaborate with key internal and external stakeholders.
Excellent project management skills.
Dynamic and energetic, hands-on approach to challenges.
Business travel to various company offices, suppliers, and partners as required.
Location : Syndax has offices in Waltham, MA and New York City and has a dispersed workforce across the United States.
Regular travel will be required for this role. To help ensure the safety and well-being of our employees, visitors, and other stakeholders, Syndax strongly encourages employees/consultants to get vaccinated/boosted against COVID-19 prior to participating in an in-person meeting or traveling on behalf of Syndax.
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Email Alert for Manager, Clinical Supply Chain jobs in Waltham, MA, United States
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