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! This is what you will do:
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 within a program, or across programs that are deemed most critical to the business. The GPD is responsible for leading a cross-functional study team (core and extended) and for providing the team with direction and guidance to enable successful study delivery. The GPD may provide input to early study planning activities based on operational expertise. The GPD is accountable to the GPT for the delivery of a study, 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 delivery.
The GPD is also responsible for providing expert input, guidance, direction, mentoring, and support to AD, CPLs on all study related operational activities. The GPD will also provide advice and support to CPLs related to study 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: Accountable for the implementation and execution of a high priority Clinical Development Plan, including all clinical trials under the Program. Member of the Core Team, 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.
Accountable for the implementation and execution of a high priority Clinical Programs, including all clinical trials under the Program including both insourced and outsourced studies.
Acts as a core member of the Global Project Team, representing Clinical Operations.
Leads and provides oversight to GSMs and GSADs assigned to related Programs, ensuring consistency across all studies within the Program.
Directly accountable and responsible for the planning, implementation and execution of pivotal, high corporate priority, key clinical trials.
Contributes strategic and operational assessment (i.e., risk management/feasibility assessment) to the development of the Global Development Plan (GDP).
Accountable to GPT Leader for planning, tracking and forecasting the Global Clinical Operations budget, resources (allocation) and timelines for the program against the agreed goals.
Develops and maintains budgets for study(s) that include short and long-range clinical forecasting and monthly accruals based on clinical activity to support Clinical Development financial goals.
Collaborates with the appropriate Functions in defining the sourcing strategy for the development 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 in-depth knowledge of the clinical data and ensures appropriate transfer of that knowledge to cross-functional study teams to achieve operational excellence.
Provides input to Program & Portfolio Management, in case of project prioritization exercises within the portfolio.
Leads or contributes to the Development Operations functional excellence efforts and initiatives, which affect cross- functional processes, as requested.
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).
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 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.
We would prefer for you to have: Advanced degree (Master, PhD, MD) is highly desirable.
PMP certification desirable.
Extensive experience for financial oversight of a global clinical development program is desirable.
Line management experience is desirable.
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.
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