Medical Director, TA - Diabetes & Renal

Medical Director, TA - Diabetes & Renal

Facility: Medical Affairs Location: Plainsboro, NJ, US

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 healthcare provider interactions and developing and implementing regulatory strategies with the 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, Obesity, Cardiovascular, Renal, Liver Health, Rare Blood Disorders, and Rare Endocrine Diseases). This role will interface with key stakeholders across 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 Medical Director Lead in the development and execution of strategic priorities within a therapeutic area, including developing the therapeutic area medical and evidence generation plans based on insights from the marketplace. This role may also lead the Core Medical Team, Extended Medical Team, and National Advisory Board meetings for a Therapeutic Area in certain instances, at the discretion of the Medical Director Lead. Assists the Medical Director Lead in developing agenda for and executing national advisory boards, assists with defining strategies to support medical education programs and reviews IME grant proposals, publication planning and execution, 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, FMA, 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 Medical Director Lead, Medical Affairs and will assist the Medical Director Lead 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 Development Strategy Directors, HEOR Directors, Global Medical Directors, Marketing, and Market Access. External relationships include expert advisory board members, investigators, other consultants, and key customer groups.

Essential Functions

• Evidence Generation
• Provide input to Product Development Plan (PDP) and Evidence Generation Plan (EGP), in collaboration with Medical Director Lead
• Review and provide insights and comments to clinical trial programs for Novo Nordisk-sponsored clinical trials
• Review proposals for investigator-sponsored studies (ISS) and provide comments to RGC 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 Development Strategy Director and Clinical Operations lead
• Support KOL engagement
• KOL and Association Engagement
• Lead planning and execution of National Advisory Board meetings
• 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 Medical Affairs Professional Association Strategy Director
• 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 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
• Serve on Core and/or Extended Medical Team as requested, and assist with development of Therapeutic Area Medical Plan (medical strategies and tactics). In certain situations, may serve as chair of Core Medical Team and/or Extended Medical Team, at the discretion of the Medical Director Lead
• Represent NNI Medical Affairs on Global Medical For a at the discretion of the Medical Director Lead
• 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. Position is Home Office Based in Princeton, NJ; Candidate should live within commuting distance to the home office or be willing to relocate to such distance.

Qualifications

• MD, DO, PhD, or PharmD required
• A minimum of 5 years of combined clinical, research or Pharma experience required
• Clinical experience managing patients with diabetes strongly preferred
• MD or DO degree is preferred
• Strong strategic mindset, understanding of market needs, resource allocation excellent communication and presentation skills, experience working in complex matrix environment and strong stakeholder management skills, 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 endocrinology and diabetes preferred

The base compensation range for this position is $250K to $315K. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance. Novo Nordisk offers long-term incentive compensation and or company vehicles depending on the position's level or other company factors. Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy.

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 View phone number on click.appcast.io. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.