stillingsbetegnelse:
International Medical Director/International Medical Manager

jobbeskrivelse:
- Medical Doctor - Denmark - Søborg Trusted to make a difference We are looking to employ a Medical Doctor with a passion to pursue a career in clinical research within Haemophilia. Join us and you’ll be working with highly talented colleagues, every one of whom strives passionately to create better treatments and care. We offer flexibility for personal development within a highly inspiring environment. In return, we trust you do your utmost to improve our patient’ lives. In Global Development, we are responsible for managing clinical drug development worldwide from early development phases to product introduction. We ensure medical and scientific documentation for clinical submissions and authorities while ensuring that the process lives up to uniform global standards, regulations and business ethics. We work in global project teams with focus on delivering viable products that make a difference to patients and ultimately benefit society. About the department Medical & Science is part of the Global Development Haemophilia organisation situated in Soeborg, Denmark. Our responsibilities include clinical development, design of clinical studies and collaboration with clinical operational staff, investigators and other scientific experts. Our tasks encompass interpreting and concluding on data obtained in our clinical trials, and supporting communication of data at scientific meetings or to regulatory authorities. We have a project-centric organisation and you will work in cross-functional teams. The job As International Medical Director/International Medical Manager you will take on the role as the medical expert within the assigned project. Your primary responsibilities will be to lead the development of the clinical strategy for a drug candidate. This will include planning the trials and having the overall medical responsibility during the execution of the clinical development program. You will be responsible for securing the medical content of the individual study reports and publications based on results from the clinical development program as well as having the overall responsibility for the content and quality of the clinical part of a submission dossier. You will be presenting medical aspects of the clinical development program at internal and external meetings (including regulatory agencies, congresses, investigator meetings etc.). Your main deliverables will be to provide input and advice on the scientific medical literature, establish and chair internal scientific boards to support the given project and to provide input and update the Project Development Plan(s). Furthermore you will establish and maintain an external support network including investigators, key opinion leaders and outstanding research scientists and establish relevant external advisory boards in cooperation with relevant stakeholders. You will be instrumental in the writing and updates of the Investigator’s Brochure, present aspects of the Project Development Program of a given project at in- and external meetings, write publications when appropriate and provide scientific support to congresses, exhibitions and symposia. The job will require some travel activity. Qualifications You hold a university degree in medicine and clinical experience preferably within the area, and most likely a scientific degree like PhD, doctoral thesis or similar experience. Candidates with clinical and/or scientific knowledge within haemophilia will be preferred however it is not a prerequisite that you have coagulation experience. You must be willing to work in a project oriented, international matrix organisation. You are flexible and able to quickly adjust to new situations in a continuously developing environment and you are fluent in written and spoken English. Good oral and written communication skills are a must. At Novo Nordisk, your skills, dedication and ambition help us change lives for the better. In exchange, we offer you an opportunity to wor

Arbejdsgiver Navn: Novo Nordisk A/S

Arbejdsgiver telefonnummer: 44448888

Arbejdsgiver faxnummer: 44442314

Job kort beskrivelse: Alment lægearbejde

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark