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Novo Nordisk Medical Director - Diabetes Cardio Renal in Plainsboro, New Jersey

About the Department

The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the Food & Drug Administration (FDA) to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to the same beat is our patient-centered focus. At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We’re changing lives for a living. Are you ready to make a difference?

The Position

The Medical Director serves as the subject matter expert for our products and related data within a Therapeutic Area (Diabetes-GLP-1, Diabetes-Insulins, Cardiorenal Diseases, Obesity, NASH, Rare Blood Disorders, Rare Endocrine Diseases, and Neurodegenerative Diseases). This role will interface with key stakeholders across Clinical Medical Regulatory (CMR), Marketing, and the Global organization to drive scientific exchange and communication with external Key Opinion Leaders (KOLs), Healthcare Professionals (HCPs), and other stakeholders. The Medical Director will also assist the Senior Medical Director in the development and execution of strategic priorities within a therapeutic area, including developing the medical product and evidence generation plans based on insights from the marketplace. This role may also lead the Core Medical Team, Project Team (co-chair), and National Advisory Board meetings for a Therapeutic Area in certain instances, at the discretion of Executive Director of Medical Affairs. Assists the Senior Medical Director in developing agenda for and executing national advisory boards, assists with defining strategies to support medical education programs and reviews Independent Medical Education (IME) grant proposals, represents Medical Affairs in Promotional Review Board (PRB) activities including reviewing medical and scientific content of promotional materials, maintains KOL relationships and serves as a consultant for Marketing, Field Medical Affairs (FMA), Scientific Center of Excellence (SCOE), Market Access, Public Affairs, and Sales. Assist with the development of strategies to appropriately position the Brand as part of the Novo Nordisk portfolio.

Relationships

This position reports directly to the Executive Director, Medical Affairs and will assist the Executive Director and Senior Director (where applicable) in managing multiple internal relationships within Novo Nordisk Inc. and Global HQ. Key internal relationships include Field Medical Affairs, Medical Strategy & Operations, Medical Information, Publications, Clinical Directors, Health Economics & Outcomes Research (HEOR) Directors, Global Medical Directors, Marketing, and Market Access. External relationships include expert advisory board members, investigators, other consultants, and key customer groups. Contribute to Product Planning Group (PPG) and Brands Extended Brand Team (EBT).

Essential Functions

  • Evidence Generation

  • Provide input to Product Development Plan (PDP) and Evidence Generation Plan (EGP), in collaboration with Senior Medical Director

  • Serve as Novo Nordisk Inc (NNI) Medical Affairs representative on Medical & Science Team

  • Review and provide comments to trial outlines/protocols for Novo Nordisk-sponsored clinical trials

  • Review proposals for investigator-sponsored studies (ISS) and provide comments to Research Grant Committee (RCG) Chair

  • Attend Research Grants Committee meetings and participate in decisions for ISS proposals

  • Assist with identification and support of National Leaders/National Expert Panels for select clinical trials, in collaboration with Clinical Director and Clinical Operations lead

  • Support investigator meetings

  • Serve on Clinical Trial Strategy Team in collaboration with Clinical Operations point, Clinical Director, and Field Medical Affairs point to identify investigators/sites and risks to trial planning and execution

  • KOL and Association Engagement

  • Assist Senior Medical Director with planning and execution of National Advisory Board meetings (or lead planning and execution of National Advisory Board meetings, at the discretion of Executive Director)

  • Deliver clinical data and other presentations at National Advisory Board meetings and gain feedback from advisors

  • Support other advisory boards with clinical data and other medical presentations

  • Partner with professional associations and their leadership to identify shared goals and initiatives, in collaboration with Public Affairs/Alliance Development team

  • Publication Planning

  • Serve on Publication Planning Group, where relevant

  • Review and provide comments to abstracts, posters, and manuscripts, including primary, secondary and HEOR publications

  • Prepare and support presenting external authors

  • Develop local US publication plan (including encore abstracts, reviews, and supplements) in collaboration with Publications Manager

  • Independent Medical Education (IME)

  • Assist in developing medical education priorities and IME plan in collaboration with IME lead

  • Review and assist with selection of proposals for IME grant funding

  • Medical Guidance

  • Train Field Medical Affairs team on relevant disease state topics and clinical trial data. Review and approve resources for FMA

  • Train Sales Teams on clinical trial data and Prescribing Information

  • Train Market Access team on clinical trial data and Prescribing Information

  • Review and approve Medical Information letters, including standard and custom letters

  • Review and provide comments to Acadamy of Managed Care Pharmacy (AMCP) dossier

  • Support Speakers’ Bureau, including presentations at Speaker Training and Curriculum Development meetings

  • Provide medical review of all materials for PRB for launch products

  • Provide input and support to Medical Information lead for PRB for non-launch products

  • Provide medical guidance to Marketing, including for development of materials for PRB and serving on Extended Brand Team (EBT)

  • Serve on Extended Medical Team (EMT) and assist with development of Medical Product Plan (medical strategies and tactics). In certain situations, may serve as chair of Core Medical Team, at the discretion of the Executive Director

  • Represent NNI Medical Affairs on Global Core Medical Team (CMT)

  • Collaborate with HEOR to provide clinical input on HEOR projects and authorship on abstracts, posters, and manuscripts, when requested

  • Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs

Physical Requirements

20-30% overnight travel required.

Qualifications

  • MD/DO with 5 years of combined clinical, research or pharma experience

  • Experience in relevant therapeutic area strongly preferred

  • 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 (expertise in clinical trial methodology and conduct, GCP principles, medical product support activities, publications, ISS, med ed)

  • Subspecialty training in relevant therapeutic area preferred

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

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.

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