1 Job in Lexington, MA
Kiniksa Pharmaceuticals is Hiring a Manager, Clinical Supply Chain Near Lexington, MA
This is an office-based role and will based in one of our offices located in Lexington, London or Zug. Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote.
Responsibilities (including, But Not Limited To)
- Ensure continuous supply of clinical trial material for assigned studies globally
- Ensure on-time startup of new studies by having supplies available as required
- Manage clinical packaging and distribution vendors
- Design and execute packaging and labelling campaigns
- Support the procurement, labeling and distribution of comparators
- Review clinical protocols and design appropriate supply chain strategy
- Work collaboratively with Clinical Operations, Quality Assurance and Regulatory Affairs
- Interpretation of a protocol or study overview to calculate total demand and forecast over time
- Managing clinical labeling including label design, translation, and production
- Preparation of a supply plan to support the demand forecast, including determination of supply overage amounts and regular inventory update to project teams
- Manage international distribution and logistics for clinical programs, including importing and exporting clinical supplies globally
- Manage clinical packaging/distribution including negotiating contracts, designing clinical supply plans and developing the distribution instructions with clinical supply chain vendors
- Develop supply strategy to maximize supply efficiency, minimize waste while identifying risk and develop risk mitigation plans
- Work with the clinical team to configure and set up Interactive Response Technology (IRT) Systems including automated randomization and drug supply management, including specification design & UAT testing
- Manage study closeouts and drug reconciliation at study end
- Ensure all clinical supply related documents are filed in the eTMF
- Develop and manage clinical supply budget for assigned studies
- Oversee Clinical Supply Chain timelines to ensure on-time completion of deliverables
- Requires a BS degree with 3 years’ experience in a Clinical Supply Chain role in a Biotechnology or Pharmaceutical environment
- Experience managing contract packaging and labeling organizations
- Experience with developing risk-based supply strategy for an early to late-stage clinical development programs
- Thorough understanding of regulatory requirements for clinical supply distribution in US, APAC, and EU including testing and labeling requirements
- Thorough understanding of cGMP, GCP, GDP and national/international transportation requirements for pharmaceutical materials
- Global distribution experience including working with QP, IRT and regional depots.
- Excellent project management and communication skills
- Must thrive in a fast-paced innovative environment while remaining flexible, proactive, resourceful, and efficient
Job Summary
Full Time
Pharmaceutical
$124k-160k (estimate)
05/10/2024
07/04/2024
kiniksa.com
LEXINGTON, MA
100 - 200
2015
MICHAEL MEGNA
$10M - $50M
Pharmaceutical
Related Companies
About Kiniksa Pharmaceuticals
Kiniksa is a biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutic medicines for patients suffering from debilitating diseases with significant unmet medical need. We have an experienced team that has advanced multiple product candidates in parallel that focus on a range of debilitating diseases with significant unmet medical need. We continue to explore expanding our pipeline in order to develop life-changing medicines for patients who need it most. We are focused on hiring and retaining a highly skilled team that has extensive experience and ...
specific skill sets relating to the selection, development, and commercialization of transformative therapies. Whether in development, research, manufacturing, technical operations, or general / administrative functions, we depend on a brilliant team to support our mission of building a global, generational company. Our benefits are competitive, and we offer dynamic career opportunities across our organization fostering a culture that embraces passion and rapid execution.
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The following is the career advancement route for Manager, Clinical Supply Chain positions, which can be used as a reference in future career path planning. As a Manager, Clinical Supply Chain, it can be promoted into senior positions as a Supply Chain Senior Manager that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Manager, Clinical Supply Chain. You can explore the career advancement for a Manager, Clinical Supply Chain below and select your interested title to get hiring information.
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