Director, Evidence Program Management II
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Director, Evidence Program Management II (Dir EPM II) is accountable for portfolio level oversight within assigned tumor area. This role also assumes strategic activities in support of Sr. Director, Evidence Program Management and serves as Sr. Director, Evidence Program Management deputy as needed.
Director, Evidence Program Management II (Dir EPM II) is accountable for the overall portfolio management of all company sponsored global studies within the assigned therapeutic area (TA) and/or early access programs (EAP) overseen by Director, Evidence Program Management I (Dir EPM I) and delivered by Associate Directors, Evidence Program Management (AD EPM), covering all program and study deliverables. Overseeing quality, budget, time, resource and risk, the Dir EPM II will have the ability to ensure and optimize the delivery of a suite of evidence studies and/or early access programs, developing operational strategies to optimise trial execution. The role also involves integrating design, feasibility, and operational planning in close collaboration with the Senior Director, Evidence Program Management (Sr Dir EPM) to achieve operational excellence in an aligned organization.
The Dir EPM II is accountable for line management and providing expert input, guidance, direction, mentoring, and support to direct reports on all study related operational activities as well as accountability for coaching and mentoring of soft skill capability development. The Dir EPM II will also provide advice and support on study related operational activities as needed, as well as coaching and mentoring support of soft skill and leadership capability development across Evidence Delivery team as needed.
Responsibilities:
Partner with Sr Dir EPM ensuring provision of expertise and operational input into the programs and/or studies (e.g. IMAP, ERT, MARCO, SDC, CSP, High impact proposals (HIPs))
Responsible to serve as AZ single point of contact for alliance studies (eg Daiichi, Merck) with responsibility for activities such as protocol reviews, governance meeting participation and alliance resource need assessments
Lead CRO selection in partnership with Sr Dir EPM, Director, Evidence Program Management I (Dir EPM I), and/or AD EPM
Responsible for partnering with relevant R&D stakeholders within assigned tumor area to align on site selection strategy during early planning phase throughout site selection activities
Project management area of expertise:
Portfolio-level interface with externally managed/outsourced partners for studies planning and delivery
Responsible for integrating design, feasibility and operational planning to ensure that all AZ sponsored studies within assigned tumor area are aligned with priorities and strategy
Accountable for oversight of all project management of deliverables in planning phase within assigned tumor area
Interface with key stakeholders cross-functionally, and/or external partners, to identify, manage and resolve issues affecting program delivery
Oversee portfolio level performance across all AZ sponsored studies against agreed upon plans, milestones and key performance metrics
Main escalation point for Director, Evidence Program Management I (Dir EPM I), and/or AD EPM to manage performance of CRO and execute contractual obligations
Line management/Team capability build area of expertise:
Develop, maintain and conduct individually tailored induction training for newcomers in the assigned tumor area
Set the clear individual and collective goals for direct reports, along with IDPs and monitor the progress over time
Support staff/team to achieve study milestones and all respective deliverables
Support recruitment and retention processes within Evidence Delivery Team
Requirements:
Essential:
Bachelor’s degree required preferably in medical or biological science or equivalent by experience
Extensive pharmaceutical industry/CRO experience within clinical study/research project delivery, drug development process and relevant guidelines, for example GCP/ICH, for a specific therapeutic and geographical area
Project Management qualification or demonstration of project management skills including scope, budget, timeline, resource management and use of associated tools
Ability to effectively work with Clinical Research Organisations/External Providers
Ability to mentor, develop and educate staff
Proven leadership promoting motivation and empowerment of others in order to accomplish individual, team and organisational objectives
Ability to look for and champion more efficient and effective methods/processes of delivering evidence studies focusing on key performance metrics around reliability, efficiency, cost and quality
Strong problem solving, stakeholder management and conflict resolution skills
Ability to lead change with a positive approach to the challenges of change for self, team and the business
See change as an opportunity to improve performance and add value to the business
Proven ability to interact widely and effectively within the company across regions, functions and cultures
Persuasive communicator in English with a proven ability to work collaboratively in a multi-cultural environment
Demonstrated ability to set and lead priorities, resources, performance targets and project initiatives in a regional and local environment
Desirable:
Experience and knowledge within compliant management of Early Access Program
Advanced degree in medical or biological sciences or field associated with clinical research
Experience of incorporating digital health and patent centric strategies into clinical studies
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AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing AZCHumanResources@astrazeneca.com.
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 authorisation and employment eligibility verification requirements.
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