Director, Evidence Program Management Ii - Gaithersburg, United States - AstraZeneca

AstraZeneca
AstraZeneca
Verified Company
Gaithersburg, United States

3 weeks ago

Mark Lane

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Mark Lane

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Description

Join the Medical Evidence Delivery Team within our Oncology Business Unit (OBU) in
Gaithersburg, MD, and be part of a team that is responsible for strategic planning and operational delivery of interventional and observational AstraZeneca-sponsored studies.

Our mission is to generate the evidence that builds confidence in and provides access to AstraZeneca therapies for patients in need.


Accountabilities:


The Director of Evidence Program Management II (Dir EPM II) oversees global studies and early access programs in a specific therapeutic area.

They provide strategic support to the Sr.

Director, Evidence Program Management and manage quality, budget, time, resources, and risk to ensure successful delivery of evidence studies and early access programs.

Will serve as Sr. Director, Evidence Program Management deputy as needed.

The role involves integrating design, feasibility, and operational planning to achieve operational excellence. Additionally, the Dir EPM II establishes consistent working methods, influences organizational practices, and enhances Evidence Delivery capabilities.

They also contribute to continuous improvement, act as a point of contact for best practices, and lead key initiatives in support of the broader EDT strategy.

Furthermore, the Dir EPM II provides guidance and support on study-related operational activities, offers coaching and mentoring for soft skills and leadership development within the Evidence Delivery team.


Responsibilities:


  • Partner with Sr Dir EPM, ensuring the provision of expertise and operational input into the programs and/or studies (e.g. IMAP, ERT, MARCO, SDC, CSP, High impact proposals (HIPs))
  • Responsible for serving 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:

  • Portfoliolevel interface with externally led/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 crossfunctionally, 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 supervise the progress over time
  • Support staff/team to achieve study milestones and all respective deliverables
  • Support recruitment and retention processes within the Evidence Delivery Team

Requirements:


Essential:


  • Bachelor's degree required preferably in medical or biological science or equivalent by experience
  • 7 years of 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
  • Experience and knowledge within compliant management of Early Access Program

Desirable Skills/Experience:

  • Experience and knowledge within compliant management of Early Access Program
  • Advanced degree in medical or biological sciences or field associated with clinical research
  • Experience incorporating digital health and patentcentric strategies into clinical studies


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 we need to connect, work at pace and challenge perceptions. **That's why we work, on average, a minimum of 3 d
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