Vice President, Head of Clinical Development – Allergy & Urticaria

<div class="content-intro"><p></p> <div> <p class="x_MsoNormal"><span data-olk-copy-source="MessageBody">ARS Pharmaceuticals is a fast-growing, innovative company dedicated to transforming the treatment of severe allergic reactions with <strong>neffy®</strong>, 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.</span></p> </div> <div></div></div><p><strong>JOB SUMMARY</strong></p> <p>The Vice President, Head of Clinical Development – Allergy & Urticaria is responsible for clinical strategy and execution across ARS Pharma’s allergy and urticaria portfolio, including chronic spontaneous urticaria (CSU) and related immunology-mediated conditions. This role owns clinical trial design and program execution from early-phase proof-of-concept through global registration and serves as the organization’s senior authority on the allergy/urticaria therapeutic area and its evolving regulatory landscape. The VP translates enterprise medical and evidence strategy into actionable, scientifically rigorous clinical development plans.</p> <p>The VP partners closely with Medical Affairs, Regulatory Affairs, Development, Technical Operations, Biometrics & Data Management, Clinical Operations, Pharmacovigilance/Safety, and Commercial/Market Access to build integrated development plans that support successful global registration and market adoption. The VP will play a critical role in building out ARS Pharma’s clinical development function and team as the allergy and urticaria portfolio scales.</p> <p><strong>ESSENTIAL JOB DUTIES & RESPONSIBILITIES</strong></p> <ul> <li>Own clinical strategy and execution for the allergy and urticaria portfolio, ensuring development plans reflect the latest science, competitive landscape, and unmet patient needs.</li> <li>Lead the design, execution, and oversight of clinical development programs for allergy and urticaria assets, from IND-enabling studies through Phase 3 registration trials.</li> <li>Lead trial design across the portfolio, including study population, endpoints, comparators, and statistical approach, in partnership with Biometrics and the C-Suite</li> <li>Translate enterprise medical and evidence strategy into detailed clinical development plans, study designs, timelines, and risk/benefit tradeoffs.</li> <li>Author and oversee clinical protocols, investigator brochures, statistical analysis plans, clinical study reports, and other core clinical documents in partnership with Biometrics and Medical Writing.</li> <li>Serve as the senior clinical development representative in interactions with FDA, EMA, and other health authorities, including IND/CTA submissions, End-of-Phase meetings, and Type B/C meetings.</li> <li>Provide medical monitoring oversight and clinical data interpretation across ongoing studies, ensuring subject safety and data integrity.</li> <li>Partner with Clinical Operations and CRO partners to ensure trials are executed on time, on budget, and to GCP/ICH standards; oversee site selection, enrollment strategy, and vendor management.</li> <li>Chair or co-chair internal safety review committees and support benefit-risk decisions and post-market clinical surveillance in partnership with Pharmacovigilance, Regulatory, and Quality.</li> <li>Contribute clinical development expertise to early- and mid-stage protocol design for pipeline expansion and business development opportunities in allergy, urticaria, and related immunology-mediated conditions.</li> <li>Partner with Medical Affairs and HEOR/RWE colleagues to ensure clinical devel