What are the responsibilities and job description for the Executive Director, Medical Affairs - NA Regional Head position at Windsor Troy Law, LLP?

Executive Director, Medical Affairs - NA Regional Head

Tbwa Chiat / Day Inc is looking for Executive Director, Medical Affairs - NA Regional Head in Waltham, MA.

This local job opportunity with ID 3073923287 is live since 2025-02-12 14 : 16 : 58.

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 Affairs will lead and oversee the company’s medical affairs strategy and activities across the North American Region.

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 North American market and ensuring alignment with regulatory and healthcare organizations. You must have established relationships with KOLs for neuromuscular diseases, ideally with Myasthenia Gravis (MG) specialists.

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.

Key Responsibilities

Medical Strategy Development & Execution :

Lead the development and execution of the North American 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 North America.

Engage in meaningful dialogue with external experts to gather insights, 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.

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.

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 5 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 or clinical development programs at a regional level.

Strong knowledge of the FDA and North American Healthcare landscape, regulatory environment, and market access challenges.

Fluency in English; proficiency in additional languages is an asset.

Ability to travel across North America as needed.

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