Associate Director, US Medical Review

Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases.

We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients.

argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx is evaluating efgartigimod in multiple serious autoimmune diseases. argenx is also advancing several earlier stage experimental medicines within its therapeutic franchises. argenx has offices in Belgium, the United States, Canada, Japan, and Switzerland.

Position Summary

The Associate Director, US Medical Review will serve as a Medical Affairs member of the US Materials Review Committee (MRC) and the US Medical Materials Committee (MMRC).

This position will report to the Head of USMA Integrated Medical Capabilities and be part of the Medical Review and Insights Community.

The Associate Director, US Medical Review, will be responsible for the Medical Review of Medical Affairs and Promotional Materials to ensure the communication of accurate, consistent, and timely information regarding products and therapeutic areas. This includes providing solutions-oriented feedback and working collaboratively with other cross-functional team members, such as Medical Affairs, Marketing, Legal, and Regulatory. Additionally, this role will also support content development within the Medical Affairs Therapeutic area and Payer teams, and Commercial teams. The Associate Director, US Medical Review, will maintain ongoing communication across the Medical Review team and Therapeutic Area and Payer peers, for awareness and consistency with strategy.

Roles & Responsibilities

• Serve as the Medical Reviewer for scientific accuracy in the promotional US Materials Review Committee (MRC) and the US Medical Materials Committee (MMRC); support Global Medical Review as needed
• Provide medical review of US Promotional and Medical Affairs materials to ensure statements are scientifically valid and accurate, truthful and not misleading, and that promotional claims are adequately supported, including the appropriateness of references cited
• Anticipates risk and proactively elevates to manager
• Support content development in Concept and/or Draft phases within the Medical Affairs and Commercial and teams, including MSL Training, MSL Content, Medical Directors, Scientific Communications, Medical Information, and Medical Training; including Medical Affairs project submission in Veeva Vault as needed
• Maintain ongoing communication and collaboration within the Medical Review team and Therapeutic Area and Payer peers for awareness and consistency with strategy
• Communicates and collaborates effectively with cross-functional groups to cultivate a positive relationship
• Maintain scientific knowledge, including: labeling, associated therapeutic areas, relevant literature, treatment guidelines and competitor information, through ongoing internal and external data sources (e.g., training, conferences)
• Participate in internal meetings to remain current on relevant Brand and overall Company strategy
  
  

Skills And Competencies

• Ability to critically evaluate literature, interpret complex data, write effectively, articulate information to a variety of audiences, and effectively negotiate with counterparts from cross-functional areas
• Detail-oriented and ability to manage various projects, solve problems, deliver on commitments, work with multidisciplinary teams, and appropriately elevate risks to manager
• Must be a strong team player/ demonstrates flexibility and a positive attitude
• Working knowledge of FDA regulations related to scientific exchange, payer communication and drug promotion, with a focus on medical review
  
  
  

Requirements

• Doctorate Degree (PharmD/MD/PhD)
• Minimum of 4 years of experience in the pharmaceutical or biotechnology setting predominately within Medical Affairs or related roles
• Direct promotional/medical review experience required (2-3 years)
• Prior experience in Payer, Neurology or Rare Disease preferred
• Strong scientific/medical written and verbal communication skills required
  
  
  

At argenx, all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer.

If you require reasonable accommodation in completing your application, interviewing, or otherwise participating in the candidate selection process please contact us at hr.us@argenx.com. Only inquiries related to an accommodation request will receive a response.