The Position

The Medical Director - Rare Hemato-Renal Dirorders serves as the subject matter expert for our products and related data within the Rare Hemato-Renal Dirorders Therapeutic Area. 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 Sr. Director - Rare Hemato-Renal Dirorders in the development and execution of strategic priorities within the 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 Director in developing agenda for and executing national advisory boards, assists with defining strategies to support medical education programs and reviews 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, 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 Senior Director - Rare Hemato-Renal Dirorders Medical Affairs and will assist them in managing multiple internal relationships within Novo Nordisk Inc. and Global HQ. Key internal relationships include Field Medical Affairs, Medical Exellence, Medical Information, Publications, Clinical Directors, 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 PPG and Brands EBT.

Essential Functions

• Evidence Generation
  • Provide input to Product Development Plan (PDP) and Evidence Generation Plan (EGP), in collaboration with Sr. Medical Director
  • Serve as 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 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 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 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. 30% overnight travel required; Position is Home Office Based; Ideal candidate can be based remote anywhere in the United States, ideally on the East Coast and near a major airport, yet able to travel to Plainsboro, NJ regularly.

Qualifications

• MD, DO, PhD, or PharmD required
• A minimum of 5 years of combined clinical, research or Pharma experience required.
  • Back-Office medical affairs function preferred.
• Experience in Hemotology, Complement-mediated disorders 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