Quality Management Director - Healthcare jobs in Maryland

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 an assigned therapeutic area. You will provide strategic support to the Sr. Director, Evidence Program Management and be responsible for quality, budget, time, resources, and risk to ensure successful delivery of evidence studies and early access programs. Also, as needed, will serve as Sr. Director, Evidence Program Management deputy.

The Dir. EPM II  will also be an expert in designing and implementing business processes and systems responsible for embedding consistent ways of working, championing new ways of working across Evidence Hubs, and within the broader OBU organization and beyond, as well as building Evidence Delivery capabilities.

In this role, you will contribute to continuous improvement, act as a point of contact for best practices, and lead key initiatives in support of the broader EDT strategy. Also, 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:

• Portfolio-level 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 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 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 patent-centric 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 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.

Why AstraZeneca?

At AstraZeneca, we change the practice of medicine and improve the patient experience by generating and communicating compelling medical evidence. We are a high-performing team within a global, growing organization. Our culture is one of openness and transparency, fused with ambition and drive. We leverage our partnerships with external experts across the industry, to create and communicate evidence that changes medical practice. It's rewarding work. Knowing that every day our input personally and directly impacts patients. We're part of a leading team, area and business and we have big ambitions to eliminate cancer as a cause of death.

Are you ready to innovate and realise the ambitions in our leading Oncology area? Join our globally-renowned Oncology area, which is leading the rapid business growth of our enterprise and ever-evolving industry. It’s an exciting time to join as we work towards our big ambitions with entrepreneurial thinking and innovation. It’s up to us to find solutions and act fast to make them happen. Apply now and be part of our mission to redefine cancer treatment!

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.