Since January 2011
Hold oversight for scientific studies and business development for strategic product. Formulate clinical development and medical strategies. Interface with regulatory authorities and prepare all necessary documentation. Responsible for abstracts for scientific meetings and congresses. Develop toxicology overview of clinical studies, perform due diligence, develop competitive overviews and provide interpretations of study data. Key achievements: Secure daily medical and safety oversight of clinical studies Secured breakthrough designation in the USA for Daratumumab Steered development of 2 protocols, received approvals, and implemented clinical studies. Developed 2 briefing packages for EMA and 2 for FDA. Orchestrated submission of one marketing application to EMA and one to FDA. Secured approvals for 7 oral and 2 poster abstracts for presentation at scientific meetings.
January 2009 --- January 2011
Medical resposible for Humira, a strategic product only available for prescription by inflammation disease specialists. Performed role of chair of the scientific advisory board, supervised all staff operations, administered budget, and oversaw medical liaisons. Developed medical strategy and managed strategic scientific development for Humira. Coordinated and managed KOL relationships. Selected sites and investigators for global studies in Denmark as well as development of local clinical studies. Orchestrated strategic medical marketing initiatives. Key achievements: Introduced a research forum for young physicians researching inflammatory diseases. Collaborated with Nordic colleagues and KOLs on preparation of a Nordic study protocol. Initiated concept of specialised medication self-treatments for remote patients and set up meetings with a KOL and groups of gastroenterologists to secure support the strategic concept. secured approval for 3 investigators initiated studies including financial support.
January 2008 --- January 2008
Within the area of oncology, responsible for clinical development and medical scientific content of the development plans for several stratigic products, phase II studies, data interpretation and clinical reports Businessplan development including preparing products for duediligence
International Scientific and Medical Advisor
January 2005 --- January 2008
Creation of medical strategy and managed all aspects of clinical development of surgical hemostasis product. Collaborated with the pre-clinical department, the patent department and an external engineering company to identify opportunities for new indications and development of a medical device for application in special endoscopic surgical situations. Authored documentation seeking marketing authorisation from the FDA in the USA. Authored an investigators brochure and developed scientific documentation for label enhancement in Europe (EMA). Key achievements: Secured marketing authorisation in the USA for strategic product. Orchestrated successful delivery of satellite symposia at international congresses and conducted hands-on training sessions for congress attendees at international congresses. Played key role in development and testing of the prototype device.
International Medical Advisor
January 2004 --- January 2005
Directed medical marketing activities related to surgery, hepatology and trauma indication for a strategic drug candidate. Performed data interpretation and developed scientific publications and congress material. Established scientific symposia’s at congresses, conducted negotiations with KOLs and speakers, and organised speaker training. Provided support to sales and marketing initiatives. Served on international and local advisory boards.Scientific responsible for data interpretation of clinical trials within haemostasis. Key achievements: Formulated medical marketing strategy for NovoSeven. Published 4 scientific articles in international peer reviewed journals and presented 3 abstracts at scientific congresses including the International Symposium on Intensive Care and Emergency Medicine and the International Society of Hemostasis and Thrombosis.
January 2001 --- January 2004
GCP and ISO certified lead auditor. Resposnible for development of protocols for clinical trials phase I-III with regards to ethics and GCP Performed audits of clinical trials phase I-III and internal systems
January 1991 --- January 2001
During my clinical education period I was trains in breast and colorectal surgery; and anaesthesia. During a research fellowship period I developed and implemented an "enhanced recovery program" in the department of colorectal surgery at Copenhagen University hospital. I have published several scietific papers in major surgical Scientific journals as well as I have presentes scientific data and have been invited speaker at major surgical congresses. I have defended my docthoral thesis at Copenhagen University: Multimodal rehabilitation after colonic resection . A clinical pathway to enhance recovery after colonic surgery.
CollaborationEfficiencyIndependenceOptimismProactivityProblem solvingResponsibilityStrategic thinkingTrust
Skills and Expertise
Develop clinical trial protocols Interact with physicians Interpret data Analyze data Assure medical qualityCommunicate with investigatorCommunicate effectively on different company levelsDesign clinical trialDesign post-marketing surveillance studyDesign protocolDevelop clinical strategyDevelop ICH/GCP compliant processesDevelop marketing strategiesGastrointestinal diseasesInteract with KOLManage budgetsMarket approvalOral presentationPrepare manuscriptPrepare investigator brochuresPresent at steering committeePresent clinical resultsPresent data at congress
MD in Medicin from Københavns Universitet in 0