Title - Group Director for Medical Evidence Quality

Location - Cambridge UK, Gaithersburg US, Warsaw PO, Gothenburg SE, Shanghai CH.

Salary - Competitive with attractive package

Are you a an effective relationship builder with expertise in Medical Affairs and real world evidence? Do you want to be part of a group that leads strategic initiatives in providing healthcare decision-makers around the world with the evidence and confidence they need on AZ therapies and support internal stakeholders with medical insight and expertise? Then this might be the right opportunity for you.

We are now recruiting an Group Director for Medical Evidence Quality within BioPharmaceuticals Medical (BPM).

BioPharmaceuticals Medical’s (BPM) responsibilities is to ensure the best patient outcomes by providing healthcare decision-makers around the world with the evidence and confidence they need on AZ therapies and support our internal stakeholders with medical insight and expertise. BPM provides medical leadership with market participation and connectivity while also impacting the life cycle planning and execution of all our products, and aims to lead AstraZeneca in achieving scientific leadership, being a great place to work, and keeping patients at the core of everything we do.

The BPM Medical Evidence organization is accountable for the delivery of global strategic studies required to generate the evidence to build the confidence on AZ therapies and additional observational, interventional and externally sponsored research required by Global Product Teams and Global Medical Teams.

What you’ll do

As a Group Director for Medical Evidence Quality you will have oversight of Quality and Compliance across the Medical Affairs organization in AstraZeneca. Accountable for driving proactive Quality and Compliance strategies, business/resource planning and team leadership in alignment with AZ Code of Ethics and the Global Policies, as agreed with relevant leadership teams across the Medical Evidence organization. Directs and supports the Medical Evidence Quality team to assure operational effectiveness and efficiencies through a continuous improvement approach. We are looking for you to build partnership with cross-functional units to establish aligned ways of working clarifying roles and responsibilities. You will have a drive to forward innovative approaches to plan, initiate, and deliver medical evidence quality as well as deliver continuous improvement of the operating and delivery models, ways of working to ensure they are fit for optimal delivery.

Other responsibilities:

• Accountable for the management and monitoring of the Quality Management System across the Medical Affairs organization in AstraZeneca.
• Manages the development of the Medical Evidence Quality team
• Develops knowledge of global issues and ensures this is incorporated into the Medical Affairs strategy
• Act as a key contact with relevant Quality and Compliance functions, for example R&D Quality Assurance and Global Compliance, as well as Quality and Compliance roles in in other functions relevant to Medical Evidence deliveries.
• Works closely with senior Medical Affairs colleagues to execute the Medical Affairs strategy within Medical Evidence Quality
• Drive strategies for processes and standards through a network of process owners and subject matter experts to proactively mitigate quality risks
• Oversight of quality related metrics, including providing guidance on developing and managing these
• Oversight of Quality Issues reported from Medical Evidence activities in appropriate tools
• Proactively drive the strategy for ensuring that the Medical Evidence organization is appropriately prepared for audits and inspections – Inspection readiness
• Engagement in Audits and Inspections – act as, or on behalf of, a Medical Evidence Audit Sponsor
• Oversight of continuous improvement activities – including driving relevant individual activities
• Interaction within Medical Evidence and, when applicable, the wider BioPharmaceuticals/Oncology Business Unit organisations – for example, Medical Excellence, Global Payer Evidence & Pricing
• Lead the recruitment and allocation of appropriately skilled staff to the Quality Evidence Team
• Provide expert line management and coaching of the team members
• Provide performance management, performance assessment and reward proposals for direct reports
• Develop, maintain, and conduct individually tailored induction training for newcomers in the team
• Ensure all direct reports have IDPs and support them in the implementation of these plans, through training or other development opportunities
• Represents Medical Evidence Quality at external events

Essential for the role

• University Degree in Life Sciences or other appropriate discipline
• Significant experience in pharmaceuticals or a related industry (8 – 10 years)
• Strong work ethics and high integrity standards
• Knowledge and experience of corporate governance and relevant regulations, laws and standards
• Knowledge of the overall pharmaceutical product development process, including stages of development and role of different functional areas.
• Knowledge of the management of observational studies and/or interventional trials
• Strong ability to work independently
• Ability to collaborate with colleagues at all levels in various geographies
• Project Management knowledge and experience
• Creates Clarity for Others to Make Decisions: individual creates the climate for others to act decisively by clarifying roles and responsibilities and limits of decision-making.
• Creates Shared Purpose Across Boundaries: individual works across boundaries to establish common purpose and goals to deliver value to the business.

Desirable for the role

• Understanding of multiple aspects within Medical Affairs
• Extensive knowledge of the latest technical and regulatory developments
• Expert knowledge of quality management and good working knowledge of GxP functions and regulations.
• Effectively challenges the business and positions quality & compliance appropriately to influence decisions: Adopts a solution-oriented approach and focuses on business enablement i.e., achievement of business goals whilst mitigating risks
• Manages change with a positive approach to the challenges of change for self, team, and the business and sees change as an opportunity to improve performance and add value to the business.

Why AstraZeneca?

At AstraZeneca you will be valued. Not only for your unique contribution, skills and background, but because we recognise people are our greatest asset. Here we are dedicated to being a Great Place to Work. Thrive in an energising environment where challenging work goes hand in hand with development. With opportunities, recognition and bright minds, there’s no better place to unlock learning and build a long-term career. Most importantly, we do meaningful work that changes lives. It’s our purpose that drives us, every day. Interested? Come and join our journey.

So, what’s next?
Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.
We will go through the applications continuously so please apply as soon as possible but no later than April the 16th 2023. Welcome with your application!