Global Program Director

The Global Program Director (GPD) is a business-critical role within Development Operations whose main accountability is the operational planning and delivery of high priority and complex clinical studies or access to medicines (AtM) program within a drug program, or across programs that are deemed most critical to the business. The GPD is responsible for leading a cross-functional study/AtM program team (core and extended) and for providing the team with direction and guidance to enable successful study/AtM program delivery. The GPD may provide input to early study/AtM program planning activities based on operational expertise. The GPD is accountable to the GPT/GMA for the delivery of a study/AtM program(s), or studies, according to the agreed upon timelines, budget and quality standards by ensuring an effective partnership and teamwork within the study team. The GPD will also interface with other internal stakeholders cross-functionally, and/or external partners, to identify, manage and resolve issues affecting study/AtM program delivery.

The GPD is also responsible for providing expert input, guidance, direction, mentoring, and support to Global Study Associate Director, GSAD on all study/AtM program related operational activities. The GPD will also provide advice and support to Global Study leads related to study/AtM program team leadership, senior stakeholder management, conflict management, etc. GPDs will also lead other non-drug programs and improvement projects as required.

You will be responsible for:

1. Accountable for the implementation and execution of a high priority Clinical Development Plan/AtM Plan, including all clinical trials/early access and post-trial access programs under the Program. Member of the Core Team or relevant sub-teams, in representation of Clinical Operations. Leads and provides oversight to Global Study Managers (GSMs) and Global Study Associate Directors (GSAD) assigned to related Program. Directly accountable and responsible for the planning, implementation and execution of pivotal, high corporate priority, key clinical trials/AtM programs.
2. Accountable for the implementation and execution of a high priority Clinical/AtM Programs, including all clinical trials/AtM program(s) under the Program including both insourced and outsourced studies.
3. Acts as a core member of the Global Project Team or AtM sub-teams, representing Clinical Operations.
4. Leads and provides oversight to GSMs and GSADs assigned to related Programs, ensuring consistency across all studies within the Program.
5. Directly accountable and responsible for the planning, implementation and execution of pivotal, high corporate priority, key clinical trials/AtM programs.
6. Contributes strategic and operational assessment (i.e., risk management/feasibility assessment) to the development of the Global Development Plan (GDP) and/or the AtM strategy.
7. Accountable to GPT/GMA Leader for planning, tracking and forecasting the Global Clinical Operations budget, resources (allocation) and timelines for the program against the agreed goals.
8. Develops and maintains budgets for study(s)/AtM program(s) that include short and long-range clinical forecasting and monthly accruals based on clinical activities to support Clinical Development financial goals.
9. Collaborates with the appropriate Functions in defining the sourcing strategy for the development/AtM programs. Partners with Country Operations Management to deliver insourced studies and provides oversight and management of CROs in outsourced studies.
10. Establishes the operational standards for the program (e.g., monitoring plans, risk mitigation strategy, and oversight of operational vendors (e.g., monitoring, labs, imaging, etc.).
11. Reviews all key deliverables (e.g., Protocol, ICF, posting, CSR, etc ) for consistency across the program. Ensures compliance with the International Conference on Harmonization - Good Clinical Practice (ICH-GCP), and EU Clinical Trial Directive throughout the entire clinical development plan. Develops in-depth knowledge of the clinical data and ensures appropriate transfer of that knowledge to cross-functional study teams to achieve operational excellence. * Ensures compliance with the Good Pharmacoviligance Practice (GPvP), AtM regulations including Early Access and Post-trial Access. Develops in-depth knowledge of the AtM and ensures appropriate transfer of that knowledge to cross-functional program teams to achieve operational excellence.
12. Provides input to Program & Portfolio Management, in case of project prioritization exercises within the portfolio.
13. Leads or contributes to the Development Operations functional excellence efforts and initiatives, which affect cross- functional processes, as requested.
14. Support other study and functional activities, as assigned.

You will need to have:
12 years of clinical research experience, 8 of which in leading roles accountable for the planning, execution and reporting of global clinical trials of diverse development phases (I – IV) or 5 of which in early access or post-trial access planning and execution. * Bachelor’s degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences, or drug development.

• Ability to lead cross-functional teams and to represent clinical operations in Core - Product Development Teams. Solid understanding of integrated development/AtM process for pharmaceuticals products.
• Leadership, project management, resource management are required.
• The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

• Advanced degree (Master, PhD, MD) is highly desirable.
• Solid experience in early access and/or post-trial access is highly desirable.
• PMP certification desirable.
• Extensive experience for financial oversight of a global clinical development program is desirable.
• Line management experience is desirable.

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.

Ready to lead and inspire? Apply now and take the first step towards a fulfilling career at Alexion, AstraZeneca Rare Disease.

Date Posted 15-Jul-2024

Closing Date 28-Jul-2024

Alexion 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.