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International Medical Director in Global Development Søborg Denmark,
Novo Nordisk (company)
Posted on : 10 April 2017
- We are looking to employ a Medical Doctor with passion for clinical development to bring better treatments to people who need them.
- Join us and you will be working with highly talented colleagues, every one of whom strives passionately to create better treatments and care.
About the department
- Medical & Science Semaglutide Approval is responsible for the medical aspects of submitting a new drug application to regulatory authorities to ensure approval for a new long acting subcutaneous Glucagon Like Peptide 1 (GLP-1) receptor agonist.
- This includes medical and scientific support to health authority interactions and the planning and execution trials.
- An important part of our work is the planning and execution of large scale Cardiovascular Outcomes Trials (CVOTs).
- Our work is done in close and dynamic collaboration with many other skill areas, each contributing with high level of expertise.
- We are a great team of currently 9 Medical Doctors.
- The department is part of a larger medical department working on clinical development of Semaglutide for the treatment of type 2 Diabetes (called Semaglutide Diabetes and Diabetes Outcomes) within Global Development.
- As Medical Specialist, you will take on a broad role where focus and daily tasks vary to a great extent, dependent on the assigned project and study life cycle stage.
- You will be a key player in the planning and execution of large scale phase 3a/3b cardiovascular outcomes trials.
- We expect you have expert knowledge within cardiology and cardiovascular outcomes trials.
- Expertise within management of diabetes and obesity will be an advantage
- We expect that you are capable of taking on the responsibility as medical responsible for early as well as late stage clinical development projects and ensure relevant process progression and decision making, all in close collaboration with cross-functional experts as well as the Medical & Science Management team and the Project Management team.
- The job includes being instrumental in providing medical and scientific support to interpretation and documentation of clinical data leading to new drug applications and variation applications, training and guidance to investigators taking part in our clinical trials, as well as periodic safety updates on marketed drugs and drugs in clinical development.
- You will collaborate closely with a variety of colleagues across the organisation and across skill areas.
- The job is globally oriented and will require strong interaction with highly skilled colleagues and external stakeholders including regulatory bodies, treating physicians and therapeutic experts.
- You must hold a University degree as a Medical Doctor and have passed the internship.
- Moreover, you must have significant experience from clinical practice, from research (hold a Ph.D.) within an area related to our research, and/or you have relevant experience with clinical development from the Pharmaceutical or Biotech industry, including a proven track record in executing clinical trials and interacting with health authorities.
- Most importantly, you have a passion for clinical research and development.
- You are a flexible, open-minded and dedicated team player with the ability to take on a team lead role.
- In addition, you thrive in a global environment of continuous development, and focus on high quality and results.
- We put patients first and do not compromise on quality and expect you to do the same.
- Interaction with internal and external global experts require proficiency in English, excellent communication, coordination and planning capacities.
- You may expect travelling activity of approximately 15-30 days per year.
Working with Us:
- We use our skills, dedication and ambition to help people with diabetes.
- We offer the chance to be part of a truly global work place, where passion and engagement are met with opportunities for professional and personal development.
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