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ARS Pharmaceuticals Operations, Inc.

Vice President, Head of Clinical Development – Allergy & Urticaria

Who can apply: US-based role. The employer has not said which states are eligible — confirm before applying.
Location as listed by the employer: “US - Remote”
Apply on ARS Pharmaceuticals Operations, Inc.'s site ↗

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About this role

ARS Pharmaceuticals Operations, Inc. is hiring for a Vice President, Head of Clinical Development – Allergy & Urticaria role. See the official posting for full details.

Requirements

  • 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.
  • 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…

Summarized from the employer's posting — check the full posting for every requirement.