Job Details

ID #53624291
Estado Massachusetts
Ciudad Woburn
Tipo de trabajo Full-time
Salario USD TBD TBD
Fuente Sirtex
Showed 2025-03-12
Fecha 2025-03-12
Fecha tope 2025-05-11
Categoría Etcétera
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Sr. Program Manager-Radiopharmaceutical

Massachusetts, Woburn, 01801 Woburn USA
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Position Summary:The Sr. Program Manager-Radiopharmaceutical will focus on the successful initiation, execution, and monitoring of any Sirtex radiopharmaceutical programs or radiochemistry programs including new product development, technical transfer, clinical studies, regulatory submission, and commercial launch.This role will be at the forefront of technological development, working closely with both internal teams and external partners to ensure the seamless transfer of robust manufacturing processes. This role involves overseeing the end-to-end process for Radiopharmaceutical products, ensuring that they meet the highest standards of safety, quality, and compliance with global regulatory requirements.Authorities/Responsibilities:Responsible for planning and execution of new production development and commercial launch of a Sirtex product in the field of radiopharmaceutical, radiochemistry and others as needed.Collaborate with a team of engineers, scientists, physicians, marketing to develop, optimize the product design and manufacturing processes for clinical application and commercialization.Collaborate with cross-functional teams and external stakeholders for Investigational New Drug (IND), New Drug Application (NDA) regulatory submissions.,Partner with business development to identify and evaluate new technological platforms and pipeline products in Radiopharmaceutical industry.Partner with Medical Affair and Clinical Affair (MACA) and external stakeholders to initiate and monitor key clinical studies and report to senior management and shareholders.Document and maintain archives for all product-related development activities such as plans, schedules, meeting minutes, management reviews, and departmental reviews.Coordinate activities between development, operational and commercial organizations from project initiation through launch.Maintains effective communication with senior management, providing awareness of critical issues and action plans for resolution of issues.This position is responsible for team integration on a program, overall project management, and for evaluation and reporting project status to senior management.

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