Global Clinical Operations Program Director (GPD)

Job Title: Global Clinical Operations Program Director (GPD)
Location: Gaithersburg, MD

 

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.
 

Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office is purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects. 

Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention. 

Introduction to Role:
 

The Global Clinical Operations Program Director (GPD) is a core global role within the Clinical Operations function of Late Stage R&D (BioPharmaceuticals and Oncology).  The span of responsibilities is broad and may support one or several products depending on their size and complexity. The products supported will be in Phase 3 development or on the market, but the program may include studies in all phases of drug development. The GPD has a delegated, from Senior Global Clinical Operations Program Director (Sr GPD), responsibility for oversight of a program of global clinical studies, covering all clinical program deliverables to scope, quality, budget, time, resource and risk, ensuring new innovative design and delivery models are used appropriately. The role involves integrating strategy, design, feasibility and operational planning to ensure clinical drug development programs are aligned with priorities and strategy. The GPD will develop the core clinical program components for governance interactions with the oversight of the Sr GPD.  The GPD acts as the lead for cross-functional teams in delivery of clinical activities assigned.

The GPD may provide project leadership for cross-functional clinical submission teams in support of regulatory marketing applications and post registration product maintenance deliverables.

Additionally, the GPD may lead or contribute to improvement and change projects within clinical operations and/or other business areas.
 

Accountabilities:

• Lead cross functional teams of experts in the planning and delivery of a defined clinical program of studies and/or clinical activities to scope, quality, budget, time, planning the resource and managing risk.
• Work closely with global study leaders to provide appropriate strategic oversight of a program of studies on behalf of Sr GPD and Clinical Program Team (CPT)
• Provide clinical operations expertise into the project (e.g. country selection, feasibility, operational input into design, risks and external partner management) using new innovative design and delivery models to support governance interactions and project start-up.
• Responsible for providing clinical operations expertise into the development of new business case opportunities for review by governance bodies (cost, timelines, quality, feasibility, risk)
• Lead cross functional Clinical Submission Teams in planning and execution of clinical contribution to Marketing Applications, maintenance support for regulatory interactions and reports and inspection readiness.
• Lead large or complex deliverables and the process to identify and solve or escalate operational issues. Drive delivery to plan through internal or external partners (alliance partners, Clinical Research Organizations (CROs), vendors and Academic Research Organizations (AROs)).
• On behalf of CPT, responsible for managing clinical plans (cost, FTEs and timelines) in business reporting system, such as PLANIT.
• Act as AZ point of escalation for study teams for external (e.g. CRO) partners for externally managed/outsourced studies as appropriate
• Responsible for leadership and program management of non-drug project work as assigned, e.g. cross functional improvement/change initiatives.
• Contribute to functional and cross-functional initiatives as Subject Matter Experts
• Mentor, coach and support people development as appropriate.
• Actively participate in networking both within and outside the therapeutic area, sharing best practises and lesson lea