Global Non-interventional Study (NIS) Lead

Are you an enthusiastic leader in observational studies, ready to shape evidence generation and drive execution in diverse local markets? This is your opportunity to make a significant impact. Apply Today!

Shape the LEO Pharma of tomorrow

At LEO Pharma, our mission transcends the conventional. We're on an ambitious path to become the leaders in medical dermatology worldwide. 

In Medical we share a “challenge accepted” mindset and are guided by our winning behaviours of simplification, collaboration, and accountability, to achieve our goals

Your new role

The Non-Interventional Study (NIS) Lead is responsible for study execution of primary data collection studies and growth of evidence in alignment with global business strategies and direction. More precisely, through the NIS Lead, the LEO Pharma country organizations are supported in the execution of observational research.

• Project initiation:  Lead the internal customer to develop the proposal and go through the LEO Pharma internal Global Governance Review Process. Coordinate author review/approvals and ensure adherence to all applicable SOPs, policies, processes, and compliance guidelines. 

• Project plan execution: Lead the execution of NIS studies, concept sheets, protocol and report writing, and facilitate key project meetings. 

• Communication material: Co-lead, in close collaboration with Publication Managers, the development of scientific communication materials that are related to the specific studies. 

• Collaborate: Work with Global and Local Medical Affairs and various cross functional teams in NIS conduct. Liaise with internal and external stakeholder, including study owners, researchers, investigators, medical leads, biostats, data managers, statistical programmers, pharmacovigilance leads, HE&OR leads and publications managers on all activities related to study conduct.

• Lead the planning execution: Oversee the planning, execution and delivery of studies with primary data collection and retrospective chart reviews (RCR) to ensure high data quality and timely delivery of scientific results.

• Central Contact: Serve as the central contact with internal stakeholders to ensure efficient communication.  

• Collaborate with all Medical Affairs:  Work with all Medical Affairs multi-functional therapy area (TA) members and contribute to the Medical Affairs strategy by generating high-quality data for assigned publication goals at TA relevant congresses.

• Lead the Study Execution Team: Manage timelines and lead meetings as needed. 

• Manage vendors and budget: Oversee quality and timeline of vendor in close collaboration with procurement and the study execution team. Handle study budget planning, forecasting, and monitoring of study related activities. 

• Continuous Improvement: Employ continuous quality improvement techniques and develop tools to assess impact of studies. Ensure SOPs and other process documents are updated and reflective to the current ways of working in liase with other relevant functions and stakeholders. 

This role is based at our head office in Ballerup, Denmark. #LI-Hybrid

Your qualifications

To succeed in this role, we imagine that you have the following qualification background:

• Degree in Life Sciences and/or a postgraduate degree (Master or Doctorate) in Epidemiology or related research field. 
• Substantial experience in observational research within pharmacoepidemiology and in the pharmaceutical  industry, contract research organization, or academic research institute. 
• Extensive experience running primary data collection studies is a requirement. 
• Experience with, working with data from electronic medical records, disease registries/ databases, insurance claims databases for health outcomes research, social media, conduct of prospective research, is a plus. 
• Experience in launch planning and execution of launch related Medical Communications tactics. 

• Knowledge of clinical development process and hands-on experience with data analysis (biostatistics and interpretation of statistical data) are essential. 

LEO Pharma is built on collaboration, innovation and curiosity. Is this you? If you bring excellent presentation and communication skills alongside strong scientific analytical skills, this could be the role for you. Apply Today!
 

Your application

You do not need to upload a cover letter, but feel free to add a few sentences in your resume or CV on why this position has your interest.