-?Denmark - Søborg
We are searching for a dedicated Medical Doctor with interested in medical devices and clinical development, who wishes to bring better treatments to people. Join us and you will be working with highly talented and engaged colleagues striving passionately to create better treatments and care for patients suffering from a range of chronic diseases including diabetes, obesity, haemophilia or growth hormone deficiency.
Global Development is responsible for clinical development of new products based on proteins and peptides and their administration. We are involved from the early development phases to product introduction and life cycle management. We manage clinical drug and device development worldwide, ensuring that processes meet uniform global standards, regulations and business ethics. We work in cross-organisational global project teams with focus on delivering viable products that make a difference to patients and ultimately benefit society.
About the department
Medical & Science Devices & Titration is part of Global Development and has medical responsibility for the drug delivery devices (e.g. pen-injectors) and new technologies supporting development of new drugs as well as life cycle management of marketed products. The department is also responsible for treat-to-target in our clinical trials. We are a team of 9 experience and ambitious Medical Doctors, each medical doctor responsible for several development projects.
Our organisation is project-centric. Internally we work in cross-functional teams, often at the interface between drug development and device development. Our key external stakeholders are the scientific and medical community, medical experts and regulatory authorities.
As Medical Specialist, you will take on the role as the medical and scientific expert within the assigned medical device projects. Your tasks will include input to and medical review of key documents related to conceptualisation, design and development of medical devices. You will assess the need for clinical trials and establish clinical development programmes in a dynamic collaboration with Device Research & Development, Clinical Operations, Marketing, Regulatory Affairs and other internal functions. This entails being involved from the initial idea for a project throughout development, testing in patients, submissions to health authorities and bringing the product to the market during the life cycle management phase. Furthermore, you will together with a cross-functional team be responsible for the clinical evaluation of medical devices, where all data supporting safety, effectiveness and benefits is assessed using your clinical background to describe the context of the device and your scientific background to identify and understand several data sources.
You will be a driving factor in the cross-organisational implementation of clinical strategies and have the medical responsibility during execution of the Product Development Plan. In addition, you will be responsible for providing high quality input for new submissions to health authorities as well as feedback to questions posed by health authorities worldwide.
Finally, you will maintain and chair a cross-functional scientific board of internal and if required external research colleagues involved in the different phases of the product development. The job will require some travel.
You must have a university degree as Medical Doctor and preferably knowledge within diabetes, obesity, haemostasis, growth hormone deficiency and/or medical device development including scientific training at PhD level or similar. Equally it is an advantage but not a prerequisite, if you have documented experience within drug or medical device development or experience in strategy planning from previous work in the Pharmaceutical industry.
You are a reliable, open-minded and dedicated team player, who thrives in a global cross organisational environment of continuous development and focuses on completion, quality and results.
The job requires proficiency in English, high communication, coordination and planning capabilities, as well as flexibility and a keen sense of quality.
Working at Novo Nordisk
At Novo Nordisk, your skills, dedication and ambition help us improve our patient's lives. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development.
For additional information, please contact Thomas Sparre on +45 3075 9160.
15 August 2017.