Vice President, Head of Clinical Development – Allergy, Urticaria

🔥 16 hours ago

🇺🇸 United States – Remote

💵 $325k - $400k / year

⏰ Full Time

🔴 Lead

👔 Vice President

👻 Ghost score 0%

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ARS Pharmaceuticals, Inc.

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2013

🏥 Healthcare

💊 Pharmaceuticals

💰 $55M Series D on 2021-08

Healthcare • Pharmaceuticals

ARS Pharmaceuticals, Inc. is a pharmaceutical company committed to developing patient-friendly treatments to address serious issues related to needle-related risks and device ease of use. The company has introduced 'neffy,' the first and only FDA-approved needle-free epinephrine nasal spray, providing an alternative delivery method for epinephrine that is easy to carry and administer. ARS Pharma aims to make these treatments accessible and affordable through savings and support programs. The company is focused on innovative therapies that empower patients and caregivers, striving to offer practical options for epinephrine delivery.

📋 Description

• Own clinical strategy and execution for ARS Pharma’s allergy and urticaria portfolio • Lead clinical development programs from IND-enabling studies through Phase 3 registration trials • Lead trial design across study populations, endpoints, comparators, and statistical approaches • Translate medical and evidence strategy into 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 • Represent clinical development in interactions with FDA, EMA, and other health authorities • Provide medical monitoring oversight and clinical data interpretation • Partner with Clinical Operations and CROs to execute trials 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 • Contribute clinical development expertise to pipeline expansion and business development opportunities • Partner with Medical Affairs and HEOR/RWE colleagues to generate evidence supporting adoption, guideline inclusion, and payer/reimbursement narratives • Engage key opinion leaders, investigators, and scientific advisory boards to inform trial design and endpoint selection • Represent clinical development in board meetings, investor updates, and partner/licensing discussions • Build, lead, and mentor a growing clinical development team

🎯 Requirements

• MD, MD/PhD, or PharmD required • 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%) • Experience presenting clinical data and development strategy to regulatory agencies, scientific advisory boards, and investigator/KOL audiences • Experience advising executive leadership on clinical development strategy, trial design, and risk/benefit tradeoffs • In-depth knowledge of allergy and urticaria therapeutic areas • Current knowledge of FDA, EMA, and global regulatory landscapes • Expertise in clinical trial design, including study populations, endpoint selection, comparator strategy, and adaptive/innovative trial methodologies • Experience managing global, multi-site clinical trials, including work with CROs and central labs • Ability to operate effectively in a hands-on, fast-paced environment with limited infrastructure and evolving organizational needs

🏖️ Benefits

• Performance-based incentive compensation eligibility • Equity • 401k matching • 100% employer-paid medical insurance for employees • 100% employer-paid dental insurance for employees • 100% employer-paid vision insurance for employees • Reasonable accommodation for qualified individuals with disabilities