Senior / Executive Director, Medical Affairs - Regional Head

Posted:
10/3/2024, 9:01:08 AM

Location(s):
Waltham, Massachusetts, United States ⋅ New York, New York, United States ⋅ Massachusetts, United States ⋅ New York, United States

Experience Level(s):
Expert or higher ⋅ Senior

Field(s):
Medical, Clinical & Veterinary

Workplace Type:
Remote

About Us

Dianthus Therapeutics is a publicly traded, clinical-stage biotechnology company dedicated to designing and delivering novel, best-in-class monoclonal antibodies with improved selectivity and potency. Based in New York City and Waltham, Mass., Dianthus is comprised of an experienced team of biotech and pharma executives who are leading the development of next-generation antibody complement therapeutics, aiming to deliver transformative medicines for people living with severe autoimmune and inflammatory diseases. To learn more, please visit www.dianthustx.com and follow us on LinkedIn.

About the Role

The Regional Head of Medical and Clinical Affairs will lead and oversee the company’s medical affairs strategy and activities across the EU region including EMEA.

Reporting to the Global Head of Medical Affairs, you will be responsible for driving medical excellence, supporting clinical development, ensuring scientific communication, and fostering relationships with key opinion leaders (KOLs), healthcare professionals (HCPs), and patient advocacy groups. You will play a crucial role in shaping the company's growth in the European market and ensuring alignment with regulatory and healthcare organizations Experience in clinical development and medical affairs is ideal to support Phase II/III programs through commercialization.

This is a unique opportunity, to join an effort to bring a best in class complement inhibitor to patients in need, and to build Dianthus presence and capabilities in the region. We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives. We are open to you working remotely, however you must be located within the Region you are leading.

Key Responsibilities

Medical Strategy Development & Execution:

  • Lead the development and execution of the European medical affairs strategy in alignment with global objectives.
  • Provide medical insights to support business and regulatory decisions
  • Collaborate with cross-functional teams (clinical development, clinical operations, regulatory affairs, commercial, and market access) to ensure scientific alignment and strategic focus.

Scientific & Medical Communication:

  • Ensure the dissemination of accurate, balanced, and scientifically sound medical information.
  • Lead the development and approval of scientific publications, presentations, and other communication materials.
  • Represent the company at key scientific and medical conferences and engage with external stakeholders.

KOL & Stakeholder Engagement:

  • Develop and maintain relationships with top regional KOLs, HCPs, and patient advocacy groups across Europe.
  • Engage in meaningful dialogue with external experts to gather insights, and feedback, and strengthen partnerships.
  • Act as the primary point of contact for key stakeholders in the region.

Clinical Development & Support:

  • Provide medical expertise to support ongoing clinical trials.
  • Collaborate closely with clinical development teams to ensure successful trial execution and compliance.
  • Provide Medical Monitoring support for all clinical programs
  • Drive investigator-initiated studies and foster collaboration with academic institutions.

Compliance & Regulatory Support:

  • Ensure that all medical affairs activities are conducted in compliance with regional regulatory requirements, ethical guidelines, and company policies.
  • Support regulatory submissions, product launches, and post-marketing surveillance activities.

Team Leadership & Development:

  • Lead and mentor a team of medical affairs professionals across the region (future).
  • Foster a culture of continuous learning and development within the medical affairs team.

Experience

  • MD required.
  • Minimum total of 10 years of experience in medical affairs and/or clinical development.
  • Extensive experience in the biotech or pharmaceutical industry, particularly in rare autoimmune diseases, Neurology or other rare diseases.
  • Excellent communication, presentation, and relationship-building skills.
  • Proven track record of successfully leading medical affairs strategies and teams and or clinical development programs at a regional level.
  • Strong knowledge of the European healthcare landscape, regulatory environment, and market access challenges.
  • Fluency in English; proficiency in additional European languages is an asset.
  • Ability to travel across Europe as needed.