Senior Director / Executive Director, Medical Affairs

ARS Pharmaceuticals Operations, Inc.

12d•$300,000 - $360,000•Onsite

About The Position

ARS Pharmaceuticals is a fast-growing, innovative company dedicated to transforming the treatment of severe allergic reactions with neffy®, the first and only FDA-approved needle-free epinephrine product. If you’re motivated to make a meaningful impact, this is your opportunity to join a collaborative, entrepreneurial, and inclusive culture. ARS Pharma is committed to improving patients’ lives and building healthier communities. We foster a culture of inclusivity, integrity, and creativity as we pursue solutions for patients and families affected by severe allergic reactions. Our product, neffy™, is a needle-free, low-dose intranasal epinephrine nasal spray rescue medication for people with Type 1 severe allergic reactions. Headquartered in San Diego, CA, ARS Pharma invites you to join our team and help make a meaningful difference for millions. The Opportunity In this role, you will inspire and lead the Medical Affairs function, guiding Medical Science Liaisons and broader teams while fostering trusted scientific relationships with Key Opinion Leaders, healthcare practitioners, medical societies, and other stakeholders. You will oversee medical information, medical education, HEOR, publication planning, lifecycle management, launch strategy, and the development and approval of promotional and non promotional medical materials. Working cross-functionally, you will be a partner with internal teams, serve on the Promotional Review Committee, and ensure Medical Affairs activities are conducted with scientific rigor, operational excellence, and compliance with applicable laws, regulations, and company policies.

Requirements

Proven ability to build a Medical Affairs function with strong strategic and operational capabilities, including experience overseeing product launches and lifecycle management activities.
Knowledge of Type 1 severe allergic reactions, including anaphylaxis, is a plus.
Broad understanding of product development, clinical trial design, regulatory requirements, payer landscape, pharmaceutical development, and healthcare environment.
Excellent strategic thinking skills, with the ability to develop plans, translate ideas into action, manage multiple priorities, identify resource needs, drive work to completion, prepare reports, and evaluate results.
Partner with Legal and Compliance to ensure Medical Affairs activities are conducted according to company policies and procedures, and in a manner compliant with all external laws and regulations.
Demonstrated ability to develop credible peer-to-peer relationships with medical experts, decision makers, and key customer stakeholders.
Excellent interpersonal, oral, and written communication skills, including the ability to communicate complex scientific concepts, deliver and tailor presentations to the audience, engage participants, and adapt to last-minute changes.
Experience with scientific presentations, medical writing, and biostatistics.
Self-directed, hands-on, and able to work independently with urgency in a fast-paced, entrepreneurial environment.
Will consider a MD, PhD, or PharmD, or other relevant advanced degree in life sciences, medicine, or a related field required; equivalent experience, including academia experience, may be considered in lieu of degree requirements.
At least 10 years of experience in medical affairs or clinical research.
At least 8 years of progressive experience leading a Medical Affairs function in biotechnology or pharmaceuticals with no less than 6 years directly managing teams and people.
Experience in the U.S. health care marketplace required.
Deep expertise in scientific communications, external expert engagement, medical strategy, and cross functional collaboration.
Strong understanding of Medical Affairs compliance and best practices.
Must be available outside normal business hours (8:00 a.m.–5:00 p.m.) during the workweek and occasionally on weekends.
Ability to maintain confidentiality and operate with the highest ethical standards and professionalism.

Nice To Haves

Knowledge of Type 1 severe allergic reactions, including anaphylaxis

Responsibilities

Develops systems and processes to support an integrated, compliant Medical Affairs function across investigational and marketed products.
Ensure compliance with corporate policies and procedures, as well as all related healthcare laws and regulations.
Builds and executes a cohesive medical education and information strategy, including HEOR models, to support corporate and brand objectives.
Hires, leads, coaches, and develops a high-performing Medical Affairs team that promotes excellence, collaboration, and accountability.
Assure that the highest quality, ethical & professional values are demonstrated in all aspects of the team’s work.
Builds trusted scientific partnerships with KOLs, medical societies, and other stakeholders through therapeutic insights and scientific education.
Provides strategic input into company-initiated and investigator-initiated studies, manages the medical education agency, coordinates publication strategy, and reviews manuscripts and abstracts as needed.
Partners with internal and external stakeholders to develop and approve medically accurate, appropriate educational materials for providers and patients.
Manages the Medical Affairs budget and ensures effective allocation of resources.