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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. 

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

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 Promotional Materials to ensure the communication of accurate, consistent, and timely information regarding products and therapeutic areas. This includes leading the MRC medical review sub-team in providing solutions-oriented feedback and working collaboratively and efficiently with other cross-functional team members, such as Medical Affairs, Marketing, Legal, and Regulatory. Additionally, this role will serve as the lead for co-creation in material development with Marketing. The Associate Director, US Medical Review, will maintain ongoing communication across the Medical Review team and Medical Affairs Therapeutic Area functional leads to support informed decision making.

ROLES & RESPONSIBILITIES

  • Serve as Lead for a sub-team of Medical Reviewer(s) in US Materials Review Committee (MRC)
    • Ensure statements are scientifically valid and accurate, truthful and not misleading, and that promotional claims are adequately supported, including the appropriateness of references cited
    • Identifies and communicates complex materials and associated benefit-risk decisions to Medical Review Community Lead
  • Communicates and collaborates effectively with cross-functional groups to cultivate a positive relationship
  • Represent Medical Review function in Medical Affairs Matrix meetings for informed decision making
  • Identifies sub-team process efficiencies related to Medical Review
  • Maintain scientific knowledge including labeling, associated therapeutic areas, publication plans, treatment guidelines and competitor landscape, through ongoing internal and external data sources (e.g., training, conferences)

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 elevates complex topics to Medical Review Community Lead
  • Must be a strong team player/ demonstrates flexibility and a positive attitude
  • Working knowledge of FDA regulations related to role

REQUIREMENTS

  • Doctorate Degree (PharmD/MD/PhD)
  • Minimum of 5 years of experience in the pharmaceutical or biotechnology setting predominately within Medical Affairs or related roles
  • Direct promotional/medical review experience required (3 years)
  • Prior experience in 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.

Average salary estimate

$140000 / YEARLY (est.)
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$120000K
$160000K

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What You Should Know About Associate Director, US Medical Review, argenx

Join argenx as the Associate Director, US Medical Review, where you’ll play a pivotal role in shaping the future of immunology and helping autoimmune patients reclaim their lives. Based in the heart of Boston, MA, this position is an opportunity to become part of a pioneering biotech company that is revolutionizing treatment options with innovative solutions like VYVGART, our leading-edge neonatal Fc receptor blocker approved for treating gMG. As the Associate Director, you will oversee the Medical Review sub-team within the US Materials Review Committee, collaborating closely with cross-functional teams in Medical Affairs, Marketing, Legal, and Regulatory to ensure that all promotional materials communicate consistent, accurate, and timely information. This role emphasizes a solutions-oriented approach and requires strong leadership skills as you guide your sub-team in evaluating promotional claims and identifying process efficiencies. Staying up-to-date with FDA regulations and scientific advancements will be crucial, as you will also represent the Medical Review function in important Medical Affairs decisions. At argenx, we are driven by a commitment to innovation and inclusion, and we encourage you to bring your unique perspective to our team as we expand our reach to more patients with transformative therapies.

Frequently Asked Questions (FAQs) for Associate Director, US Medical Review Role at argenx
What responsibilities does the Associate Director, US Medical Review at argenx have?

The Associate Director, US Medical Review at argenx is responsible for overseeing the Medical Review of Promotional Materials within the US Materials Review Committee. This includes ensuring that promotional claims are scientifically valid and appropriately supported, leading a sub-team of Medical Reviewers, and fostering collaboration across various cross-functional teams to ensure effective communication and informed decision-making.

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What qualifications are required for the Associate Director, US Medical Review position at argenx?

Applicants for the Associate Director, US Medical Review position at argenx must hold a Doctorate Degree, such as PharmD, MD, or PhD. Additionally, a minimum of 5 years of experience in the pharmaceutical or biotechnology industry, particularly within Medical Affairs or related roles, is essential. Direct promotional or medical review experience of at least 3 years is also required, with a preference for candidates having a background in Neurology or Rare Disease.

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What skills are crucial for the Associate Director, US Medical Review at argenx?

Key skills for the Associate Director, US Medical Review position at argenx include the ability to critically evaluate literature and interpret complex data, strong written and verbal communication skills, and competence in negotiation with cross-functional teams. Additionally, being detail-oriented, adept in project management, and possessing knowledge of FDA regulations are crucial for success in this role.

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How does the Associate Director, US Medical Review at argenx work with other teams?

The Associate Director, US Medical Review at argenx collaborates closely with various departments, including Medical Affairs, Marketing, Legal, and Regulatory. This role requires effective communication to cultivate positive relationships and promote team synergy while ensuring the accurate dissemination of information within the scope of promotional materials.

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What is the culture like at argenx for someone in the Associate Director, US Medical Review role?

At argenx, the culture is inclusive and encourages innovation. As an Associate Director, US Medical Review, you will be part of a team that values collaboration and the integration of diverse ideas. The company strives to grow not only in its scientific endeavors but also in fostering an environment that inspires its people to achieve their best work for the benefit of patients.

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Common Interview Questions for Associate Director, US Medical Review
Can you describe your experience with promotional material review?

In responding to this question, emphasize specific examples from your previous roles where you ensured the scientific validity and accuracy of promotional materials. Talk about how you managed communication with cross-functional teams to align on compliance and creative strategies.

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How do you stay updated on industry regulations and product knowledge?

It’s vital to showcase your commitment to continuous learning. Share methods you use, like attending workshops, subscribing to industry journals, or participating in conferences to maintain your knowledge of FDA regulations and therapeutic areas relevant to the Associate Director position.

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What strategies do you employ to lead a team effectively?

In your response, mention practical strategies such as setting clear goals, encouraging open communication, and providing constructive feedback. Highlight your experience in fostering team collaboration and driving efficiency in processes to achieve collective objectives in a Medical Review setting.

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How do you approach the interpretation of complex scientific data?

Discuss your analytical skills and methodologies for breaking down complex data. Mention how you relate these findings to promotional claims and medical evidence, ensuring accuracy and relevance in all communications as the Associate Director, US Medical Review.

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Can you give an example of a challenging regulatory issue you faced?

Answer this question by sharing a specific challenge you encountered, your thought process in resolving it, and the outcome. Focus on your ability to communicate effectively with regulatory bodies and your actions to ensure compliance without compromising the integrity of promotional materials.

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What do you see as the most significant challenge in medical review?

Identify a relevant challenge, such as maintaining compliance amid rapidly changing regulations, and discuss how you would proactively address it through effective teamwork and continuous education within your role at argenx.

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Describe a time when you had to negotiate among conflicting opinions.

Use a specific example to highlight your negotiation skills. Talk about how you facilitated a balanced discussion and strategically steered outcomes that aligned with scientific integrity and corporate goals.

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What is your experience in working within multidisciplinary teams?

Illustrate your experience collaborating with professionals from diverse backgrounds, emphasizing the importance of various viewpoints in achieving successful promotional strategies while fulfilling the requirements of the Medical Review team.

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How do you handle tight deadlines in your work?

Showcase your time management skills by describing methods you use to prioritize tasks, delegate responsibilities when appropriate, and maintain quality standards under pressure in your role as Associate Director, US Medical Review.

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What motivates you to work in the medical review field?

Express your passion for the intersection of science and patient care. Emphasize your desire to contribute to accurate medical communication that ultimately benefits patients, which aligns well with the mission of argenx.

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EMPLOYMENT TYPE
Full-time, on-site
DATE POSTED
March 30, 2025

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