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ARS Pharmaceuticals is seeking a Vice President, Head of Clinical Development to lead clinical strategy and execution for the company's allergy and urticaria portfolio, including chronic spontaneous urticaria (CSU) and related immunology-mediated conditions. This is a VP-level role responsible for owning clinical trial design and program execution from early-phase proof-of-concept through global registration, serving as the organization's senior authority on the allergy/urticaria therapeutic area and regulatory landscape.
Key responsibilities include: developing and executing clinical strategy for the allergy and urticaria portfolio; leading design, execution, and oversight of clinical development programs from IND-enabling studies through Phase 3 registration trials; translating enterprise medical and evidence strategy into detailed clinical development plans; authoring and overseeing clinical protocols, investigator brochures, statistical analysis plans, and clinical study reports; serving as the senior clinical development representative in FDA, EMA, and other health authority interactions; providing medical monitoring oversight and clinical data interpretation; partnering with Clinical Operations and CRO partners to ensure trials meet timelines, budgets, and GCP/ICH standards; chairing or co-chairing internal safety review committees; contributing clinical expertise to early- and mid-stage protocol design for pipeline expansion; partnering with Medical Affairs and HEOR/RWE colleagues to generate evidence supporting adoption and reimbursement; engaging key opinion leaders and scientific advisory boards; representing clinical development in board meetings and investor updates; and building, leading, and mentoring a growing clinical development team.
Required qualifications include: extensive experience presenting clinical data and development strategy to regulatory agencies, scientific advisory boards, and investigator/KOL audiences; demonstrated ability to advise executive leadership on clinical development strategy, trial design, and risk/benefit tradeoffs; in-depth knowledge of allergy and urticaria therapeutic area including disease biology, standard of care, competitive pipeline, endpoints, biomarkers, and patient-reported outcome measures; current knowledge of FDA, EMA, and global regulatory landscape for allergy, urticaria, and biologics/immunology programs; demonstrated expertise in clinical trial design including study population, endpoint selection, comparator strategy, and adaptive/innovative methodologies; experience managing global, multi-site clinical trials with CROs and central labs; and ability to operate effectively in a fast-paced, hands-on environment with limited infrastructure.
