US-NJ, Director Clinical Development & Medical Affairs - Hemostasis Job 448897500A0-MZ
|Requisition ID 52874BR|
Title Director Clinical Development & Medical Affairs - Hemostasis
Job Category Clinical Development
Job Description Purpose
Within Biopharm Medical, this Director functions as a clinical/medical advisor for Novo Nordisk Inc (NNI) and key external customers to further scientific exchange. Incumbent provides product and field scientific support to Clinical, Medical and Marketing by using academic credentials and scientific expertise to communicate with health care providers and organizations. The Director will also provide leadership and direction for the conduct and reporting of ongoing local Phase I-IV clinical trials. The Director will provide support to Medical Information, Marketing and Regulatory Departments as needed and will be responsible for overseeing the publication of data and review articles in the hemostasis therapeutic area. The Director will also play a major role in the establishment and function of expert advisory panels in the areas of hemostasis and hemophilia. In addition, the Director will work with and influence medical and scientific aspects of global clinical development projects.
Position reports to the Senior Director, Medical Affairs-Hemophilia. The Director will work closely with Headquarters, the Clinical Trial Management organization, Medical Writing department, the Regulatory Affairs department and Medical Affairs and Marketing organizations. Additional key internal relationships are with the regional medical liaisons and directors, research clinicians and clinical project managers, marketing, and Sales personnel. External relationships include key opinion leaders (KOL’s), academic institutions, managed care organizations, physicians, nurse practitioners, and pharmacists.
Administrative Duties: Provide monthly (or more frequent, when required) report on all activities to Executive Director.
Advocacy Development: Identify, contact, develop and maintain relations with health care providers to establish and/or support the use of NNI products; when necessary, assist in resolving issues pertaining to that use. Responsible for establishing and coordinating the scientific activities of consultant and advisory boards.
Clinical Support: Maintain a thorough working knowledge of NNI, its products, current scientific research and publications associated with same. Provide medical review for hemophilia related promotional materials. Provides leadership for scientific support activities and supports Clinical Trial Organization (CTO) personnel as needed. Provides support to Medical Affairs, conduct needs assessment for therapeutics in healthcare, the risks of intervention and the potential market for intervention. Scientific support for marketed products and development projects focusing on NovoSeven® in the hemophilia/congenital bleeding disorder area. Support the drug information unit, by providing timely review of materials developed for communication with customers, as well as responding to inquiries where specific professional expertise in hemostasis/hemophilia clinical science is required. Works with the Executive Director, Hemostasis, the Director, Marketing and the Project Manager(s) to identify scientific needs and research opportunities and implements tactics to support scientific and business needs in the U.S.
Conduct of Clinical Trials: Assist in the development of timelines, and budgets, relevant to the management of ongoing local trials and registries. Ensure timely publication of clinical trial results. Helps to support and analyze clinical trial and registry data relating to Phase I-IV studies. Identify academic centers and investigators to initiate and/or participate in clinical trials and identify key areas of future research. Obtain expert medical community input as required to design high quality studies. Provide regional medical input on the global clinical development plans related to hemophilia. Serve as an advisor to clinical research teams for projects in early stage development. Write, review, and/or approve and ensure quality Phase I-IV clinical trial protocols.
Coordination of Educational Programs: Assist with training of field personnel on product knowledge and use of technical information in selling situations.
Insurance Reimbursement & Coverage Projects: Design, develop, and deliver scientific presentations to individuals and groups of strategic importance to NNI.
20-30% overnight travel required.
* A M.D. degree with completed residency program required, preferably in hematology, critical care or related field
* A minimum of 5 years’ experience in pharmaceutical industry; hemostasis, hemophilia, bleeding and clotting disorders experience may be substituted for industry experience
* Clinical trial experience desirable
* Strong strategic mindset, understanding of market needs, resource allocation, etc.
* Strong tactical familiarity with the design, overseeing and assessment of clinical trials and with other MA tools
Novo Nordisk is an Equal Opportunity Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity.
If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
Department CMR - CLIN DEV & OUTCOMES RESEARCH (1)
Position Location US - Plainsboro, NJ
State/Provinces US - NJ
Job/Position Country US
At Novo Nordisk, we know that driving change on a global level and improving treatment outcomes for people with diabetes and other chronic diseases begins here at home. That's why we make an unmatched commitment to our employees, our families and our communities. That means outstanding rewards, industry-leading training programs, and an environment that supports you to achieve your goals at every level. It's all part of the Novo Nordisk Way. It includes our Vision and our commitment to the Triple Bottom Line principle – helping us find the right balance between compassion and competitiveness
With a career at Novo Nordisk, you’ll feel a difference right from the start. It’s a sense of inspiration and mobility that comes from a shared belief in driving positive change for people, families, and communities everywhere. Congratulations on taking your first step!
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