Sr. Program Manager-Radiopharmaceutical

Company Description

Sirtex Medical is a global leader in healthcare, with offices in the U.S., Australia, Germany, and Singapore, dedicated to improving patient outcomes.

Our mission is to be at the forefront of minimally invasive cancer and embolization therapies. By partnering with physicians, we aim to provide innovative products that enhance patient outcomes and simplify treatments. Achieving this ambitious goal requires passionate and talented individuals who are committed to making a difference. Our flagship product, SIR-Spheres® Y-90 resin microspheres, is a targeted radiation therapy for liver cancer. To date, we have delivered over >150K doses across 50+ countries, significantly impacting patients' lives worldwide. Our success is fueled by our dedication to serving the medical community, maintaining professionalism, fostering a collaborative work culture, nurturing an entrepreneurial spirit, and continuously pursuing innovation and improvement.

At Sirtex, we are committed to creating a great workplace. We offer a range of benefits, programs, and services to support our employees, ensuring they have opportunities to contribute to our success and advance their careers. Join our inclusive community, where you can collaborate with talented colleagues, bring your ideas to life, and advance your career, all while delivering innovative healthcare solutions to patients.

Job Description

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.

Qualifications

Educational Prerequisites and Skill Requirements:

• Bachelor’s Degree or higher in Radiochemistry, Chemistry, or Biochemistry, and a minimum of 5 years of experience in Good Manufacturing Practice (GMP) environment.
• 5+ years’ experience of Radiopharmaceutical product development and launch as a project lead or program manager is required.
• 8+ years of proven experience in program management with an emphasis on project planning, scope/schedule control, problem solving, risk mitigation, communications.
• Project Manager Professional (PMP) certificate preferred.
• Demonstrated project management, consulting, process flow development and facilitation skills.
• Ability to successfully perform in a matrix accountability structure, reporting the progress of deliverables and project updates to senior leadership team.
• Proficient communications skill (oral, written and presentation) with the ability to communicate effectively through all levels of the organization.
• Strong computer skills including knowledge of MS Project, Excel, Word, PowerPoint, and Outlook.
• Excellent engagement, facilitation,