Job Description Purpose
Use medical and clinical expertise in design, implementation and monitoring of clinical studies (from Phase 1 to 4) in a team setting. Provide medical and scientific support in other aspects of company activities in the assigned therapeutic area.
Reports to the Executive Director- Clinical Development & Research- Diabetes & Obesity. Internal relationships include working with Headquarters, North America (NA) Clinical Medical Regulatory (CMR) including Clinical Trial Management, Medical Affairs, Regulatory Affairs and other Novo Nordisk Inc. (NNI) skill areas. External relationships include expert advisory board members, investigators, regulators, academic and pharma associations and other consultants.
Clinical Study Management: Provide regional medical & scientific input into trial planning and project strategic documents, including NNI Evidence Generation Plans and Product Development Plans. Provide regional medical & scientific input to trial outlines and trial protocols. Manage all required local protocol amendments/deviations. Assist in the recruitment of investigators for clinical studies and provide medical support to investigator meetings. Provide protocol training, disease specific training and titration training. Assure timely initiation of studies; act as liaison with Regulatory, project teams, and investigators. Support recruitment & retention activities. Provide medical monitoring and follow-up and support Risk Based Monitoring activities. Obtain expert medical community input. Regulatory Liaison: Assist in providing medical representation at Regulatory meetings. Write and/or review clinical sections of clinical trial reports, statistical reports, investigator’s brochures, investigational new drug application (INDs), new drug application (NDA) and responses to Regulatory questions. Provide medical and scientific input to advisory committee hearings when requested. Provide medical and scientific input to labelling. Assist in the interpretation of regulatory guidelines and directives to judge risk and causality. Medical and Scientific Support for Health Economics & Outcomes Research (HEOR) & Market Access Activities: Provide medical and scientific input to HEOR studies, real-world evidence (RWE) studies and value dossiers for market access. Provide medical and scientific input to Marketing/Market Access departments as needed. Project Management Liaison: Assist in developing clinical program time lines, budgets, and strategies. Through the project development team, assure timely initiation and completion of studies of qualified patients. Other essentials: Must maintain necessary credentials and remain in good standing with the medical community and medical ethics boards. Stay abreast of regulatory requirements and guidelines and current trends and medical practice in the field of endocrinology, diabetes and obesity, including reports and intelligence on key and critical new technologies or treatment advances. Represent Novo Nordisk (NN) in regulatory interactions, investigators’ and expert advisory board meetings, external professional societies, pharma associations, seminars, and conventions. Collaborates with other skill areas in Clinical Development & Outcomes Research (CDOR), CMR and NNI in general to ensure seamless collaboration across skill areas.
· M.D. required with a PhD additionally desired.
· A minimum of 6 years relevant experience required; pharmaceutical experience preferred.
· Diabetes, Obesity and/or NASH experience desired.
· Prior clinical research or related experience (e.g. monitoring of clinical studies, knowledge of drug development phases, statistical research methodology experience).
· Leadership skills; project management skills; effective communication and presentation skills.
· Strong collaborative mindset required.
· Must maintain necessary credentials and remain in good standing within the medical community and medical ethics boards.
Requisition ID 51802BR
Job Description Purpose