Global Program Director

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three 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.

Introduction to role

Are you ready to own the charge in transforming clinical studies into groundbreaking medical advancements? As a Global Program Director, you'll play a pivotal role in Development Operations, steering high-priority and complex clinical studies that are crucial to our business. You'll manage varied teams, facilitating efficient program delivery and collaborating with internal and external collaborators to tackle challenges directly. Your expertise will develop early study planning and post-marketing commitments, driving success through effective collaboration and strategic oversight. Ready to make a difference?

Accountabilities

• Coordinating the implementation and execution of observational/RWE studies in the Clinical Development Plan, post-marketing, and Ph4 studies.
• Acts as member of the program Core Team or relevant sub-teams, in representation of Clinical Operations.
• Leads and provides oversight to Global Study Managers (GSMs and GSAMs) and Global Study Associate Directors (GSAD) assigned to related Program.
• Directly responsible for planning, carrying out, and leading all aspects of crucial, high-priority corporate clinical trials/post-marketing studies, encompassing both in-house and contracted studies.
• Contributes strategic and operational assessment (i.e., risk management/feasibility assessment) to the development of the Global Development Plan (GDP) or GMA Product Tactical Plan.
• Report to GPT/GMA Leader for planning, tracking, and forecasting Global Clinical Operations budget, resources, and timelines in line with program goals.
• Develops and maintains budgets for study(s)/program(s) that include short and long-range clinical forecasting and monthly accruals based on clinical activities to support Clinical Development financial goals.
• Collaborates with the appropriate Functions in defining the sourcing strategy for the development/life cycle programs. Partners with Country Operations Management to deliver insourced studies and provides oversight and management of CROs in outsourced studies.
• 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.).
• Reviews all key deliverables (e.g., Protocol, ICF, www.clincaltrials.gov 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 comprehensive understanding of the clinical data and facilitates effective sharing of that information with interdisciplinary study teams in order to achieve operational excellence.
• Ensures compliance with the Good Pharmacoviligance Practice (GPvP). Develops in-depth knowledge of the AtM and ensures appropriate transfer of that knowledge to cross-functional program teams to achieve operational excellence.
• Provides input to Program & Portfolio Management, in case of project prioritization exercises within the portfolio.
• Leads or contributes to improving operational efficiency within Development Operations, influencing cross-functional processes as needed.
• Support other study and functional activities, as assigned.

Essential Skills/Experience

• 12 years of clinical research experience, 8 of which in leading roles accountable for the planning, execution and reporting of global studies of diverse development phases (I – IV)
• Bachelor’s degree or equivalent experience in one of the fields 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/GMA Teams. Proficient in leading all aspects of the complete management process for pharmaceutical 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.

Desirable Skills/Experience

• Advanced degree (Master, PhD, MD) is highly desirable.
• Solid experience in post-marketing studies 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 an exciting career at Alexion, AstraZeneca Rare Disease.

#LI-Hybrid

Date Posted

Closing Date

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 accommodations@Alexion.com. Alexion participates in E-Verify.