Vice President, Head of Clinical Development – Allergy & Urticaria

US - Remote💼 Full-time💰 $325,000–$325,000🗓 2026-09-14 → 2026-09-27

Core

Lead clinical strategy and execution for ARS Pharma's allergy and urticaria portfolio, including chronic spontaneous urticaria (CSU) and related immunology-mediated conditions, from early-phase proof-of-concept through global registration.

Role type

Vice President, Head of Clinical Development (Allergy & Urticaria)

Builds

Global clinical development programs and evidence generation for needle-free epinephrine and related biologics/immunology assets.

Domain

Biotechnology / Pharmaceutical / Allergy & Immunology

Deliverable

Required skills

Clinical trial design (IND through Phase 3), regulatory strategy (FDA/EMA), team leadership (medical directors/scientists), KOL engagement, protocol authorship, risk/benefit analysis, CRO management, statistical approach definition, endpoint selection.

Preferred skills

Board Certification in Allergy/Immunology or Dermatology, MD/PhD, experience in biologics/immunology programs.

Technologies

GCP/ICH standards, UAS7, CU-Q2oL, itch/hive severity scores, BLA/NDA

Responsibilities

Own clinical strategy and execution for the allergy and urticaria portfolio; Lead design and oversight of clinical development programs from IND-enabling studies through Phase 3 registration trials; Translate enterprise medical strategy into actionable clinical development plans; Author and oversee clinical protocols, investigator brochures, and statistical analysis plans; Serve as senior 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; Build, lead, and mentor a growing clinical development team.

Seniority

Executive (VP), hands-on strategic leadership

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