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JOB SUMMARY

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.

ESSENTIAL JOB DUTIES & RESPONSIBILITIES

• Own clinical strategy and execution for the allergy and urticaria portfolio, ensuring development plans reflect the latest science, competitive landscape, and unmet patient needs.
• Lead the design, execution, and oversight of clinical development programs for allergy and urticaria assets, from IND-enabling studies through Phase 3 registration trials.
• Lead trial design across the portfolio, including study population, endpoints, comparators, and statistical approach, in partnership with Biometrics and the C-Suite
• Translate enterprise medical and evidence strategy into detailed clinical development plans, study designs, timelines, and risk/benefit tradeoffs.
• 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.
• 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.
• Provide medical monitoring oversight and clinical data interpretation across ongoing studies, ensuring subject safety and data integrity.
• 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.
• 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.
• 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.
• Partner with Medical Affairs and HEOR/RWE colleagues to ensure clinical development plans generate evidence that supports adoption, guideline inclusion, and payer/reimbursement narratives.
• Engage key opinion leaders (KOLs), investigators, and scientific advisory boards to inform trial design and endpoint selection (e.g., UAS7, CU-Q2oL, itch/hive severity scores).
• Represent clinical development in board meetings, investor updates, and partner/licensing discussions as needed.
• Build, lead, and mentor a growing clinical development team (medical directors, clinical scientists, medical monitors), fostering a culture of scientific rigor, compliance, and collaboration.

KNOWLEDGE, SKILLS, & ABILITIES:

• 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.

EDUCATION AND EXPERIENCE

• 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%).