Vice President, Head of Clinical Development – Allergy, Urticaria

🕒 Setembro 14

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $325.000 - $400.000 / ano

⏰ Tempo Integral

🔴 Especialista

👔 Vice-presidente

👻 Score fantasma 0%

O que significa: quão provável esta vaga está aberta sem contratação ativa.Como ler: 60% ou mais significa que achamos que é uma vaga fantasma. Pontuações mais baixas preocupam menos.Como pontuamos: tempo em aberto, republicações, vagas abertas vs tamanho do time, rapidez para fechar vagas, e se o salário está divulgado.Observação: é uma estimativa de dados públicos, não um julgamento da empresa. Vagas reais podem ter pontuação alta, então use como uma dica, não como um fato.

Candidatar-se

Encontrar Vagas Remotas Similares

Configurar Alerta de Email para Novas Vagas

📊 Verifique sua pontuação de currículo para esta vaga

Melhore suas chances de conseguir uma entrevista verificando sua pontuação de currículo antes de se candidatar.

Enviar Currículo

ARS Pharmaceuticals, Inc.

SiteLinkedInTodas as Vagas

11 - 50 funcionários

Fundada em 2013

🏥 Saúde

💊 Farmacêutico

💰 $55.000.000 Series D em 2021-08

Healthcare • Pharmaceuticals

A ARS Pharmaceuticals, Inc. é uma empresa farmacêutica comprometida em desenvolver tratamentos amigáveis ​​ao paciente para abordar questões sérias relacionadas aos riscos associados a agulhas e à facilidade de uso de dispositivos. A empresa introduziu o 'neffy', o primeiro e único spray nasal de epinefrina aprovado pela FDA sem agulha, fornecendo um método alternativo de administração de epinefrina que é fácil de transportar e administrar. A ARS Pharma visa tornar esses tratamentos acessíveis e econômicos através de programas de economia e suporte. A empresa está focada em terapias inovadoras que empoderam pacientes e cuidadores, esforçando-se para oferecer opções práticas para a administração de epinefrina.

Descrição

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

• 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