Vice President, Head of Clinical Development – Allergy & Urticaria

The role

The Vice President, Head of Clinical Development manages clinical strategy and execution for the allergy and urticaria portfolio. This role leads clinical trial design and program execution from early-phase proof-of-concept through global registration.

What you will do

• Own clinical strategy and execution for the allergy and urticaria portfolio
• Lead design, execution, and oversight of clinical development programs from IND-enabling studies through Phase 3 registration trials
• Lead trial design including study population, endpoints, comparators, and statistical approach
• Translate enterprise medical and evidence strategy into clinical development plans
• Author and oversee clinical protocols, investigator brochures, statistical analysis plans, and clinical study reports
• Serve as senior clinical development representative in interactions with FDA, EMA, and other health authorities
• Provide medical monitoring oversight and clinical data interpretation
• Partner with Clinical Operations and CRO partners to ensure trials are executed on time and to GCP/ICH standards
• Chair or co-chair internal safety review committees
• Build, lead, and mentor a growing clinical development team

Required qualifications

• MD, MD/PhD, or PharmD
• 12+ years of progressive clinical development leadership in the biotechnology or pharmaceutical industry
• Significant hands-on clinical development experience in allergy, urticaria, or related immunology-mediated therapeutic areas
• Demonstrated success leading clinical programs from IND through registration (BLA/NDA)
• Experience presenting clinical data and development strategy to regulatory agencies, scientific advisory boards, and KOL audiences
• Experience advising the executive leadership team on clinical development strategy, trial design, and risk/benefit tradeoffs
• In-depth knowledge of the allergy and urticaria therapeutic area
• Current knowledge of the FDA, EMA, and global regulatory landscape for allergy and urticaria
• Demonstrated expertise in clinical trial design
• Experience managing global, multi-site clinical trials, including work with CROs and central labs
• Ability to operate in a hands-on, fast-paced environment with limited infrastructure
• U.S.-based

Nice to have

• MD preferred
• Board Certification in Allergy/Immunology, Dermatology, or a related specialty

Benefits

• Performance-based incentive compensation
• Equity
• 401k matching
• 100% employer paid Medical, Dental & Vision

About the company

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.