The Global Program Team Lead (GPTL) drives one or more drug development programs and is fully accountable to the Therapeutic Area head and governance bodies (Global Medicine Team and Development and Commercial Steering Committee DCSC) for maximizing the value of program within his/her area of responsibility. This value maximization is to be implemented within the target and resource framework as determined by senior management governance bodies. Key interfaces for the GPTL will be: Global Program Team R&D and VISion Senior Leadership Team and governance bodies (e.g. Scientific Review Committee) functional stakeholders including business development international and US commercial Global Ops and other partners.

The Senior Director GPTL is responsible for providing strategic direction and leading the global drug development for 1 Global Program Team with a simple Phase III clinical development program or more than 1 Global Program Teams with clinical development programs in Phase I / II. Typically a GPT Lead would conduct their GPT work as part of a GMT and under the supervision of a GMT Lead (except for medicines with only one indication).

What You Will Do

• Program ownership with final accountability for clear definitions of program goals plans decisions and deliverables to meet those goals

• Provides strategic direction and leadership of global development programs from PostPoC to BLA/NDA/MAA for assigned projects in accordance with the global R&D strategy. Provides global development strategy and leadership for assigned projects to ensure clear goal setting and robust development plans for effective and efficient development. (This will entail working closely with core team members functional leads and other colleagues to collaborate and ensure their buyin and knowledgesharing in establishing and implement the global development strategy for assigned projects.

• Ensures that the GPT implements its plans and adheres to key development milestones for assigned projects

• Accountable for aspects of preclinical CMC clinical plans and programs across from PostPoC through commercial approval for assigned projects

• Leads the global project team and reviews development plans for assigned projects and thorough product lifecycle management for assigned projects

• Contributes to objective setting and appraisal of core team members for program related activities

• Keeps senior management informed

• Is accountable for the program budget

• Ensures high performance team effectiveness

As the accountable program(s) owner/CEO the Global Program Team Lead (GPTL) leads and chairs the Global Program Team (GPT) leading the creation of an integrated development plan maintaining a strategic focus and ensuring the GPTs commitments are met.

The GPTLs role is one of leadership being proactive and interactive and emphasizing partnership with all GPT members and other stakeholders and consultants both within and outside R&D. The GPTL should stimulate creative and productive discussion motivate ownership and urgency (when necessary) as well as robust discussions of risk identification and mitigation opportunities and ensure clarity of purpose and responsibilities with the GPT. The GPTL has negotiation and persuasion skills necessary to ensure success of the program and sets goals for the GPT and specific programrelated goals for the Core Team members.

GPTLs are the voice of the GPT up the line (GMT Leadership R&D and VISion Leadership Development and Commercial Steering Committee and Executive Committee)and the principal liaison and partner to other groups.

Who You Are

• Science or medical degree (e.g. MD PhD PharmD) with specialist training or significant experience in either Haematology or Nephrology.

• Total leadership experience including line/project management multidisciplinary program management experience which includes leadership in more than one IND/IMPS BLA/NDA/MAA Advisory Committee or other PMDA/EMA/FDA meetings is desirable

• Minimum of ten 10 years of experience in drug development in pharmaceuticals biopharmaceuticals biotechnology or equivalent crossfunctional leadership experience

• Demonstrated experience leading the development of at least one development candidate with adherence to quality excellence and efficiency

• Demonstrated experience leading drug development projects and activities in a matrixed global organization

• A broad understanding of how to communicate and work well with team members and relevant people as well as scientists and external decisionmakers worldwide

• A thorough understanding of how to influence local and global regulatory scientific and commercial environments

• Ability to assimilate data recognize key variables and analyze complex situations

• Has experience leading preparation of PMDA/EMA/FDA milestone meetings such as PreIND EoP1 EoP2 PreBLA/NDA Advisory Committees focusing on the key strategic issues

• Excellent understanding of the interdependencies of the various disciplines (e.g. CMC Pharm/Tox PK Clinical Regulatory Marketing Finance) what needs to be evaluated simultaneously vs. sequentially etc. from a strategic planning/risk management time/event/cost point locally and globally

• Has a firm understanding of how to educate/advise/operate with respect to Regulatory Guidances/Internal SOPs/Project bestpractice behaviours.

At Alexion you will find a collaborative culture that encourages innovation and a diverse environment where your contributions are valued. You will have the opportunity to be at the forefront of rare disease research and make a meaningful difference in patients lives.

Working at Alexion

Were inspired to think differently to create better outcomes. By creating an unparalleled employee experience our organization is equipped to adapt and enrich employees with a productive engaging and enjoyable work experience while accelerating worldclass leadership and innovation capabilities that can deliver on our mission. Each of us is accountable for delivering innovative medicines and supportive technology with integrity so we can truly understand and better the lives of people affected by rare diseases. Together we can transform lives every day