Scientific Study Leader - BioPharmaceuticals Medical, Cardiovascular, Renal and Metabolism (BPM CVRM)

Are you ready to take on a role leading studies for medical evidence generation, in close collaboration with other subject experts? 

We have an exciting opportunity to join our Biopharmaceuticals Medical team (BPM) as Scientific Study Leader (Associate Director, Evidence Strategy), within our growing Cardiovascular, Renal & Metabolism (CVRM) Therapy Area (TA) at our vibrant site in Gothenburg, Sweden.  
 

BioPharmaceuticals Medical (BPM) ensures the best patient outcomes by providing healthcare decision-makers around the world with the evidence and confidence they need on AstraZeneca (AZ) therapies. We provide scientific insights and medical expertise, with the aim of achieving scientific leadership, whilst aspiring to be a great place to work keeping patients at the core of everything we do!

The BPM CVRM Evidence Strategy function leads the Medical Evidence generation across CVRM disease areas. The scope includes different type of scientific studies, ranging from pragmatic interventional studies to observational studies based on secondary data, and internal sponsorship by AZ as well as Externally Sponsored Research by Academia and Health Care Professionals.  
 
What you’ll do? 
The role Scientific Study Leader for CVRM, reporting to the CVRM Evidence Strategy Group Director, is leading epidemiology and observational research in close collaboration with the Evidence Strategy Leads as well as the cross-functional study team members with complementary expertise for the successful delivery of studies based on observational research methodologies. 
 

The role is integral throughout the lifecycle of a drug, from drug discovery and development through commercialization of pharmaceuticals, related the implementation of Evidence strategies in a specific disease area and study planning to generating the evidence required to transform health care and make sure the patients get access to the right medicine in the right time. The evidence needs to fulfil the requirements by the regulators, payers, policy makers, HCPs and patients to facilitate patient access and appropriate use of AZ medicines.  
 
Major activities include design, initiation, management, conduct, analysis, and reporting of observational studies, including critical appraisal of relevant epidemiological literature and development of medical evidence plans to fill critical knowledge gaps. The role is strategic as well as scientific and involves shaping and executing evidence plans on observational studies aligned with the global medical strategy.  

Typical Accountabilities 

• Scientific study leadership in epidemiology and observational research studies, including planning, design, execution, analysis, interpretation, and communication of assigned observational studies, applying relevant epidemiological and analytical methods and ensuring that the studies have relevant quality, are conducted in accordance with written procedures and current legal requirements and internal standards, and fulfil the requirements by the multiple external stakeholders; regulators, payers, policy makers, HCPs and patients to facilitate patient access and appropriate use of AZ medicines  

• Scientific Committee coordination and Investigator Management to bring scientific insights and maximize the value of the study while establishing constructive working relationship/interactions with external scientific experts. Promote good research practices, including considerate utilization of emerging methodologies, and technology and represent AstraZeneca’ position when interacting with external experts, collaborative groups, and contract research organizations

• Manage briefing of and facilitate translation of scientific data to relevant messaging for senior leaders and internal stakeholders on assigned study, as applicable and in collaboration with relevant roles 

• Active contribution to Evidence strategies and study planning to generate the evidence required to transform health care and make sure the patients get access to the right medicine at the right time. 

• Contribute with subject matter expertise in corporate governance procedures for review and approval of medical studies (defined by SOPs) as well as internal trainings 

 
Essential requirements: 

• Doctoral level degree (Ph.D. or equivalent) in epidemiology or related health science field and with significant experience (5+ years) in the health care environment, pharmaceutical industry or closely related epidemiological research. Alternatively, an MSc or MPH with substantial experience in the health care environment or equivalent.  

• Excellent knowledge in epidemiological methodology and ability to apply it at an international level within the pharmace