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ARS Pharmaceuticals, a fast-growing biopharma company, is seeking a Senior Director of Medical Affairs to lead and build out the Medical Affairs function. The company's flagship product, neffy®, is the first and only FDA-approved needle-free epinephrine nasal spray for severe allergic reactions (anaphylaxis).
In this role, you will serve as the executive leader of Medical Affairs, overseeing Medical Science Liaisons and broader teams while building trusted scientific relationships with Key Opinion Leaders, healthcare practitioners, medical societies, and other stakeholders. You will be responsible for the full spectrum of Medical Affairs activities: medical information, medical education, health economics and outcomes research (HEOR), publication planning, product lifecycle management, launch strategy, and development/approval of promotional and non-promotional medical materials.
Key responsibilities include:
- Developing systems and processes to support an integrated, compliant Medical Affairs function across investigational and marketed products
- Building and executing a cohesive medical education and information strategy, including HEOR models
- Hiring, leading, coaching, and developing a high-performing Medical Affairs team
- Building trusted scientific partnerships with external stakeholders through therapeutic insights
- Providing strategic input into company-initiated and investigator-initiated studies
- Managing publication strategy and coordinating with medical education agencies
- Partnering with internal and external stakeholders to develop medically accurate educational materials
- Managing the Medical Affairs budget and resource allocation
- Serving on the Promotional Review Committee and ensuring compliance with all applicable laws, regulations, and company policies
You will work cross-functionally with internal teams, Legal, and Compliance to ensure all Medical Affairs activities are conducted with scientific rigor, operational excellence, and full regulatory compliance.
Ideal candidates will have proven experience building and leading a Medical Affairs function with strong strategic and operational capabilities, including product launch and lifecycle management experience. Knowledge of severe allergic reactions and anaphylaxis is a plus. You should have a broad understanding of product development, clinical trial design, regulatory requirements, the payer landscape, and the healthcare environment. Excellent strategic thinking, relationship-building, communication, and scientific communication skills are essential.
