Senior Director, RI Medical Evidence Strategy

AstraZeneca•Gaithersburg, MD

About The Position

At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to improve lives of people with serious diseases. Biopharmaceuticals Medical (BPM) Respiratory and Immunology (RI) mission is to ensure every person living with respiratory and immunology disease receives the right care at the right moment - maximizing health and minimizing the impact on daily life. As an integral part of global BMP RI, Medical Evidence function drives this mission by providing healthcare practitioners, policy-makers, patients, and payers around the world with strategically prioritised evidence, either directly driving evidence strategy and study delivery or working with AstraZeneca’s local markets. The BPM RI Medical Evidence Strategy Director role at AstraZeneca is a senior lead epidemiologist role, driving medical world evidence strategy and end-to-end delivery, focused on (but not limited to) real-world evidence and covering a portfolio from Ph3 projects to post launch marketed products across RI disease areas. The scope includes different type of scientific studies, ranging from real-world database observational to pragmatic interventional studies, and from AZ sponsored studies executed internally or with vendors to externally-led AZ supported studies executed by Academics and Health-Care Professionals. The global Medical Evidence Strategy Lead is a role combining strategy, science, and people management skills. They report to the Head of Medical Evidence Strategy and partner closely with the Head(s) of medical brands/disease areas. Strong leadership and partnering with the BPM Leaders, an ability to identify evidence opportunities and requirements, while leading a team of 2-4 Medical Evidence Scientific lead FTEs to deliver planned studies, is critical to be successful in the role. The Medical Evidence Strategy Lead provides insights and functional expertise in several cross-functional teams as as well as briefings to senior AZ stakeholders and the external community. The global Medical Evidence Strategy Lead sets, together with the Medical Affairs lead, a strategic brand medical evidence plan, revised annually, and is accountable for set-up and delivery of the tactical global medical evidence plan. They are experts as independent scientific leads for the planning and execution of real-world studies, both primary and secondary, and consult on observational methods. They supervise, develop and coach their direct reports ensuring cohesive efficient ways-of-working within their team and with other key functions. They are responsible for their teams’ evidence study delivery from scientific excellence to adherence to timeliness, budget, and compliance with Standard Operating Procedures. Furthermore, the Medical Evidence Strategy Lead role is responsible for managing governance activities for medical evidence studies (Global and Local studies) to the highest quality standards. This may include chairing of the protocol Evidence Review Team as well as other activities defined by Standard Operating Procedures. These responsibilities require an extensive experience within the pharmaceutical industry, with deep knowledge of medical evidence methodologies and significant experience of communicating impactful evidence. To excel in this role, you should bring deep expertise in the design, conduct and analysis of medical research, combined with a therapeutic knowledge, a strategic mindset, and people-management skills. Exceptional communication skills applied across the teams internally, including your team, and externally when presenting evidence to a wide range of audience are essential for success.

Requirements

Doctoral level degree (PhD/PharmD), or MSc/MPH in Epidemiology or Public Health with significant experience (10+ years for both PhD or MSc/MPH) of evidence strategy and generation primarily in pharma business, but also across CRO or academia.
Experience with direct people management
Proven record of setting strategic and tactical evidence plans
Extensive hands-on experience of clinical/observational research, drug development process and relevant guidelines (GCP/ICH)
Persuasive communicator in English, with a proven ability to work collaboratively in a multi-cultural environment
Ability to drive concise impactful messages from evidence studies
Knowledge of drug life cycle management
Respiratory or Immunology therapeutic and disease area knowledge
Broad knowledge of health care systems
Integrity and high ethical standards
Proven ability to interact widely and effectively across functions, regions and cultures

Nice To Haves

Doctoral level degree in Epidemiology plus MD or PharmD with clinical experience
Extensive Pharma industry experience, preferably including experience from local Marketing Company
Extensive experience from leading and managing people in a global, matrix environment
Experience and proven ability of leading cross-functional teams in evidence generation strategy and delivery to support physician/payer/policy/patient needs
Experience with protocol review process and other types of evidence study governance
Expertise in Respiratory or Immunology disease area

Responsibilities

Medical Evidence Strategy Leadership: Lead and partner with the Medical Affairs Leads to ensure successful Medical Evidence Strategy, aligned with medical priorities in the TA (Therapeutic Area), Disease Area (DA) and for specific assets.
Identify evidence requirements/gaps and evidence priorities, based on good understanding of clinical practice, disease area and applicable methods.
Implement sustainability and health policy objectives in Medical Evidence Strategy and Tactical plans
Study Delivery and Governance: Responsibility for development and delivery of brand-specific Medical Evidence tactical plans on time&budget with high scientific quality and impact
Scientific Lead for End-to-End studies: Applying appropriate Study Design & Analytical methods to generate robust scientific evidence, based on all applicable research methodologies (ranging from pragmatic interventional studies and implementation science to observational studies based on secondary data and utilization of emerging technology and AI).
Lead governance procedures, as applicable, for review and approval of medical studies (defined by SOPs).
Impact and Communication: Translate evidence into messaging driving decisions for clinicians, payers, regulators, and internal governance; communicate clearly to senior leadership.
Talent and Culture: Lead, coach, and develop a high-performing team; foster a culture of scientific rigor, delivery excellence, and excellence in communicating evidence impact.
Cross-Functional Integration: Drive collaboration across Medical, Health Economics/Payer Evidence, Medical/Biostatistics, Market Access, Clinical, and Commercial to deliver cohesive plans and impact.
Methodology and Standards: Define and uphold scientific standards, methods, and quality systems for observational research, interventional studies, and evidence synthesis.
External Leadership: Represent AZ in scientific forums and partnerships; shape external evidence standards through collaborations and publications.

Benefits

qualified retirement program [401(k) plan]
paid vacation and holidays
paid leaves
health benefits including medical, prescription drug, dental, and vision coverage

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