Clinical Development Lead, Pulmovant

🕒 Setembro 22

🇺🇸 Estados Unidos – Remoto (EUA)

⏰ Tempo Integral

🟠 Sênior

👻 Score fantasma 20%

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.

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Pulmovant

SiteLinkedInTodas as Vagas

11 - 50 funcionários

🏥 Saúde

💼 Consultoria

🍽️ Alimentos e Bebidas

Healthcare • Consulting • Food & Beverage

A Pulmovant é uma empresa comprometida em transformar a vida de pacientes com doenças pulmonares por meio do desenvolvimento de terapias inovadoras. Seu principal produto, o mosliciguat, tem como objetivo fornecer um tratamento inalável, de uso único diário, para hipertensão pulmonar, caracterizado por seu mecanismo inovador de ativação de sGC. Com um foco singular em atender às necessidades únicas de pacientes que sofrem de condições pulmonares, a Pulmovant está engajada em extensos ensaios clínicos para avançar suas opções de tratamento pioneiras.

Descrição

• Provide clinical and scientific input to study design, protocol concepts and development, statistical analysis plans, and reporting • Provide medical strategic oversight and accountability for study designs, protocol development, and regulatory documents with cross-functional teams • Lead execution and management of clinical studies, especially the Phase 3 trial, including study delivery, recruitment, site activation, data review and analysis, and reporting in compliance with GCP and regulatory standards • Monitor the therapeutic and regulatory landscape and provide guidance for program strategy • Collaborate with opinion leaders, Principal Investigators, internal clinicians, translational sciences, and clinical operations • Attend and present at investigator meetings and site initiation visits • Contribute to protocols, Clinical Study Reports, Annual Reports, safety reports, Health Authority pre-meeting packages, Investigator Brochures, and periodic clinical reports • Prepare abstracts, manuscripts, presentations, and clinical sections of regulatory documents • Maintain knowledge of ICH-GCP, external regulations, and procedures • Serve as primary medical accountability and oversight source, medical lead, liaison between investigators and internal study teams, and relationship manager for key opinion leaders and Health Authorities

🎯 Requisitos

• MD/DO degree or equivalent is required • Minimum of 5–7 years’ experience conducting clinical research trials in the biopharmaceutical industry • Hands-on experience in protocol development and clinical trial monitoring • Strong written and verbal communication skills • Willingness to engage with investigators, key opinion leaders, external advisors, and regulatory authorities • Ability to effectively give presentations at conferences, advisory meetings, and other public forums • Willingness to educate and mentor internal and external colleagues and collaborators • Strong ability to work within, lead, and motivate a cross-functional matrixed team • Scientific acumen and communication skills to influence and collaborate with scientific, regulatory, and business leaders • Sound strategic, clinical, technical, operational, and ethical judgment with uncompromising integrity • Ability to travel as needed • Board Certification or Board Eligibility in internal medicine with subspecialty training or experience in cardiopulmonary/respiratory medicine is highly desirable • Experience with late-phase clinical development is ideally desired • Experience with U.S. and European Health Authority interactions and submission of clinical regulatory documents is desirable