US-NJ, Director- Clinical Development & Research (Multiple positions) Job 444488400A1-MZ
|Requisition ID 51802BR|
Title Director- Clinical Development & Research (Multiple positions)
Job Category Clinical Development
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.
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 (2)
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!
Novo Nordisk is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.
Please visit our website at www.novonordisk.com