What are the responsibilities and job description for the Clinical Supply Lead, Global Clinical Supply position at Alexion Pharmaceuticals?
The Clinical Supply Lead (CSL) will provide leadership, project planning, and oversight of clinical supply manufacturing, operational activities, and logistics to support the advancement of Alexion RDU clinical programs. This position will guide the various clinical supply operations vital to deliver investigative medicinal products for priority clinical studies and programs. The CSL will facilitate and lead discussions across PDCS related to the 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 maintain KPIs and performance metrics for their programs.
Accountabilities
- Working with Clinical Supply Managers and Clinical Manufacturing to develop timelines and manufacturing schedules to deliver IMP for clinical programs;
- Coordinating and leading sub-teams within PDCS and QA responsible for managing operational activities to successfully deliver DS, DP, and FP for clinical trials;
- Collaborating closely 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 deliver 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.
Essential Skills / Experience
Desirable Skills / Experience
When we put unexpected teams in the same room, we fuel bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace, and challenge perceptions. That's why we work, on average, a minimum of four days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
Joining Alexion means embracing an opportunity where work isn’t ordinary. We are a beacon in the global Biopharmaceutical landscape. Our closeness to patients brings us closer to our work and each other. Combined with our brave, pioneering spirit – we are truly unique in R&D and healthcare. At Alexion, grow and innovate in a business with a rapidly expanding portfolio. Enjoy the entrepreneurial spirit and autonomy of a leading biotech. You’ll join an energizing culture where people build connections to explore new ideas. As an important member of our team, you'll meet the needs of some of the most underserved patients in the world. You will be empowered with tailored development programs designed not just for skill enhancement but for fostering a deep understanding of our patient's journeys. You’re supported by exceptional leaders ready to lift you in marketing, compliance, and beyond. Make an impact by driving change with integrity, supported by a culture that celebrates diversity, innovation, and connection to patient experiences.
If this sounds like a team you want to be part of, we’d love to talk!
Date Posted
06-Feb-2025
Closing Date
13-May-2025Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact Alexion participates in E-Verify.
