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

• 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 partners.

• 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.

• Detailed knowledge and understanding of cGMP, ICH/cGXP guidelines and global Health Authority requirements.

• Proficiency in computer software applicable to IVRS/IWRS, Excel, PowerPoint, SmartSheets, SharePoint, and MS Project.

• Exceptional organizational, communication, and presentation skills to lead projects and timelines.

Desirable Skills/Experience

• Experience with regulatory submissions is a plus.

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!

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.