46 Associate Director, Clinical Supply Lead Jobs in Boston, MA
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Associate Director, Clinical Supply Lead
$148k-188k (estimate)
Full Time | Pharmaceutical
4 Days Ago
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Alexion Pharmaceuticals,Inc. is Hiring an Associate Director, Clinical Supply Lead Near Boston, MA
This is what you will do: The Clinical Supply Lead (CSL) will provide leadership, project planning and oversight of clinical supply manufacturing, operational activities and logistics to support advancement of Alexion RDU clinical programs. This position will help to shepherd the various clinical supply operations necessary to deliver investigative medicinal product for priority clinical studies and programs. The CSL will facilitate and lead discussions across PDCS related to manufacture of drug substance and drug product, finished goods packaging/labeling and quality and regulatory operations necessary to deliver IMP to patients. The CSL will work with the Clinical Planning team to develop clinical study forecasts and build aggregate demand for clinical programs. The CSL will work across PDCS to help meet corporate objectives and also maintain KPIs and performance metrics for their programs.
You will be responsible for:
You will be responsible for:
- Working with Clinical Supply Managers and Clinical Manufacturing to develop timelines and manufacturing schedules to deliver IMP for clinical programs;
- Organizing and leading sub-teams within PDCS and QA responsible for managing operational activities to successfully deliver DS, DP and FP for clinical trials;
- Liaising with and representing Clinical Supply as a member of the cross-functional CMC Team to understand upcoming clinical trials and build out study plans and timelines;
- Working closely with the CMC Team Lead and CMC Project Manager for a respective asset to communicate supply risks and updates as required;
- Liaising with the Clinical Planning team to build out clinical trial and technical demand forecasts and aggregate program demand for DS, DP and FP;
- Maintaining the technical demand register for respective programs to compile clinical and technical demands across each of the PDCS pillars;
- Developing and executing on project plans and schedules that represent the appropriate level of detail and task independency. Ensure timely follow-up to all commitments in a project plan;
- Proactively addressing risk management issues and implementing business continuity plans;
- Acting as a key member of respective CMC project teams representing clinical supply
- Preparing supply and cost forecasts with the intent to identify cost reduction opportunities and develop and manage clinical supply budgets.
- Minimum of 8 years of related experience in the pharmaceutical industry with at least 5 years of direct experience in Global Clinical Supply Management.
- In-depth knowledge of the drug development and clinical trial process
- Project management experience, preferably previous oversight of clinical supply programs.
- Ability to communicate and maintain collaborative relationships effectively with key internal and external stakeholders.
- Experience with financial management of supply chain activities including departmental budgeting.
- Demonstrated experience with global clinical supply forecasting, planning, manufacturing, packaging, labeling, and clinical trial designs.
- Thorough knowledge and understanding of cGMP, ICH/cGXP guidelines and global Health Authority requirements.
- Proficiency in computer software applicable to IVRS/IWRS, Excel, Power point, SmartSheets, Sharepoint, and MS Project.
- Exceptional organizational, communication and presentation skills to manage project and timelines.
- Experience with regulatory submissions a plus.
- The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
Job Summary
JOB TYPE
Full Time
INDUSTRY
Pharmaceutical
SALARY
$148k-188k (estimate)
POST DATE
06/23/2024
EXPIRATION DATE
06/23/2024
WEBSITE
alexion.com
HEADQUARTERS
BOSTON, MA
SIZE
3,000 - 7,500
FOUNDED
1992
TYPE
Public
CEO
LUDWIG N HANTSON
REVENUE
$5B - $10B
INDUSTRY
Pharmaceutical
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About Alexion Pharmaceuticals,Inc.
Alexion develops and commercializes immunoregulatory drugs for the treatment of autoimmune and cardiovascular diseases.
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