[Hiring] Vice President, Head of Clinical Development @ARS Pharmaceuticals

Role Description

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.

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.

Qualifications

• Experience presenting clinical data and development strategy to regulatory agencies, scientific advisory boards, and investigator/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 — disease biology, standard of care, competitive pipeline, endpoints, biomarkers, and patient-reported outcome measures.
• Current knowledge of the FDA, EMA, and global regulatory landscape for allergy and urticaria (and biologics/immunology programs generally), including relevant guidance documents and precedent approvals.
• Demonstrated expertise in clinical trial design, including study population, endpoint selection, comparator strategy, and adaptive/innovative trial methodologies.
• Experience managing global, multi-site clinical trials, including work with CROs and central labs.
• Demonstrated ability to operate effectively in a hands-on, fast-paced environment with limited infrastructure and evolving organizational needs.

Requirements

• MD, MD/PhD, or PharmD required (MD preferred); Board Certification in Allergy/Immunology, Dermatology, or a related specialty a plus, with 12+ years of progressive clinical development leadership in the biotechnology or pharmaceutical industry.
• Significant hands-on clinical development experience in allergy, urticaria (including chronic spontaneous urticaria), or related immunology-mediated therapeutic areas.
• Demonstrated success leading clinical programs from IND through registration (BLA/NDA), including direct authorship of protocols and regulatory submissions.
• Executive presence and ability to partner effectively with the C-Suite, and cross-functional leaders across Regulatory, Biometrics, Clinical Operations, Pharmacovigilance, and Commercial in a publicly traded environment.
• U.S.-based; ability to travel domestically and internationally for key internal and partner meetings (up to 20–30%).

Benefits

• Highly competitive compensation & benefits package.
• Base salary range for this position is $325,000 to $400,000 and may be eligible for performance-based incentive compensation.
• Eligible for Equity, 401k matching, and excellent benefits package including 100% employer paid Medical, Dental & Vision for employees.