Vice President, Head of Clinical Development – Allergy, Urticaria

This is a fully remote position, open to applicants in United States.

📋 Description

• Take charge of the clinical strategy and execution for ARS Pharma’s allergy and urticaria portfolio.

• Lead clinical development initiatives from IND-enabling studies through Phase 3 registration trials.

• Oversee trial design across various study populations, endpoints, comparators, and statistical methodologies.

• Convert medical and evidence strategies into clinical development plans, study designs, timelines, and risk/benefit assessments.

• Write and supervise clinical protocols, investigator brochures, statistical analysis plans, clinical study reports, and other essential clinical documents.

• Represent clinical development in discussions with the FDA, EMA, and other health authorities.

• Provide oversight for medical monitoring and interpret clinical data.

• Collaborate with Clinical Operations and CROs to ensure trials are executed on schedule, within budget, and in compliance with GCP/ICH standards.

• Manage site selection, enrollment strategies, and vendor relationships.

• Chair or co-chair internal safety review committees, supporting benefit-risk evaluations and post-market clinical surveillance.

• Contribute clinical development expertise to expand the pipeline and explore business development opportunities.

• Work alongside Medical Affairs and HEOR/RWE teams to generate evidence that supports adoption, guideline integration, and payer/reimbursement strategies.

• Engage with key opinion leaders, investigators, and scientific advisory boards to guide trial design and endpoint selection.

• Represent clinical development in board meetings, investor updates, and partner/licensing discussions.

• Build, lead, and mentor an expanding clinical development team.

⛳️ Requirements

• MD, MD/PhD, or PharmD is required.

• A minimum of 12 years in progressive clinical development leadership within the biotechnology or pharmaceutical sector.

• Extensive hands-on clinical development experience in allergy, urticaria (including chronic spontaneous urticaria), or related immunology-mediated therapeutic areas.

• Proven track record of successfully leading clinical programs from IND through registration (BLA/NDA), including direct authorship of protocols and regulatory filings.

• Executive presence and capability to collaborate effectively with C-Suite executives and cross-functional leaders across Regulatory, Biometrics, Clinical Operations, Pharmacovigilance, and Commercial sectors in a publicly traded setting.

• Must be based in the U.S.

• Willingness to travel domestically and internationally for key internal and partner meetings (up to 20–30%).

• Experience presenting clinical data and development strategies to regulatory bodies, scientific advisory boards, and investigator/KOL audiences.

• Proven experience advising executive leadership on clinical development strategies, trial design, and risk/benefit considerations.

• In-depth understanding of allergy and urticaria therapeutic areas.

• Up-to-date knowledge of FDA, EMA, and global regulatory frameworks.

• Expertise in clinical trial design, including study populations, endpoint selection, comparator strategies, and adaptive/innovative trial methodologies.

• Experience managing global, multi-site clinical trials, including collaboration with CROs and central laboratories.

• Ability to function effectively in a hands-on, fast-paced environment with limited infrastructure and shifting organizational needs.

🏝️ Benefits

• Eligibility for performance-based incentive compensation.

• Equity options.

• 401k matching program.

• 100% employer-covered medical insurance for employees.

• 100% employer-covered dental insurance for employees.

• 100% employer-covered vision insurance for employees.

• Reasonable accommodations for qualified individuals with disabilities.