Senior Director, Clinical Development

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🕒 Maio 7

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $230.000 - $270.000 / ano

⏰ Tempo Integral

🟠 Sênior

👔 Diretor

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Loyal

SiteLinkedInTodas as Vagas

51 - 200 funcionários

⚕️ Seguro de Saúde

🤖 Inteligência Artificial

☁️ SaaS

Healthcare Insurance • Artificial Intelligence • SaaS

A Loyal é uma plataforma digital de saúde líder de ponta a ponta, projetada para unificar os pontos de contato de atendimento para pacientes e provedores. Com foco em melhorar a experiência de saúde por meio da tecnologia, a plataforma integra aprendizado de máquina, processamento de linguagem natural e soluções de gestão de dados líderes do setor. A Loyal oferece ferramentas para gerenciamento de dados de provedores e localizações, engajamento digital, otimização de busca de atendimento, autoagendamento de pacientes, IA conversacional, campanhas de CRM, lembretes de consultas e gestão de reputação. Ela ajuda sistemas de saúde a transformarem suas operações, aumentarem o engajamento dos pacientes e melhorarem os resultados de saúde, garantindo acesso contínuo a informações e processos de atendimento.

Descrição

• Own the clinical development strategy for our portfolio of veterinary drug programs, including target product profiles, pivotal pathway planning, and key endpoints aligned with CVM expectations. • Build and manage detailed timelines for product development • Communicate strategy and development timelines across multiple teams within Loyal • Design companion animal clinical trials (pilot, field safety, and pivotal effectiveness studies) with appropriate statistical powering, endpoint justification, inclusion/exclusion parameters, and handling of operational constraints (e.g., heterogeneous populations, compliance variability). • Develop protocols, investigator brochures, SAP inputs, and essential documents tailored for investigators and staff in veterinary practice settings. • Work closely with statisticians on statistical design, randomization schemes, interim analyses, and data quality plans. • Partner with clinical operations to execute protocols with GCP compliance and serve as medical expert throughout in-life phase. • Provide medical and scientific oversight for all clinical studies, including: • Eligibility decisions • Case reviews and AE/SAE reporting • Protocol deviations and issue escalation • Interpretation of clinical data trends during trial execution • Support Clinical Operations with site engagement strategy, investigator training, and owner-facing communication frameworks. • Partner with Veterinary Affairs on real-world applicability, disease models, and clinician feedback loops. • Lead clinical components of regulatory interactions, including: • Pre-Submission meetings • Technical section responses • Study protocol reviews with regulators • Evidence summaries for FOI packages • Ensure that all clinical components meet VICH, GCP, and CVM guidance standards. • Work tightly with R&D to vet new drug targets and mechanisms and interpret pre-clinical data • Regulatory to align development plans with CVM requirements. • Veterinary Affairs to ensure clinic workflows and veterinary input shape study design. • Clinical Operations on execution strategy, site selection, and quality. • Commercial to ensure label-enabling claims are supported by data. • Lead clinical data review, analyses, and messaging strategy. • Develop authoritative veterinary medical clinical narratives for regulatory submissions, publications, and scientific communications. • Author study reports, abstracts and external presentations as needed. • Build and mentor a growing, high-functioning clinical development team with both veterinary medical and technical backgrounds. • Foster a culture of scientific excellence, operational pragmatism, and veterinary investigator-centered study design

🎯 Requisitos

• DVM or equivalent. • 10 -12+ years of experience in clinical development in animal health clinical development. • Demonstrated experience designing and leading clinical trials, including protocol authorship, data review, and cross-functional collaboration. • Prior oversight of safety evaluation, study conduct, and interpretation of clinical endpoints. • Strong understanding of evidence requirements for regulatory approval. • Ability to lead in a fast-paced, high-accountability biotech environment. • Direct experience with FDA-CVM VICH guidelines. • Experience in companion animal medicine, bonus if experience is in aging/longevity or quality-of-life endpoints. • Background working with veterinary clinics, practice networks, or decentralized trial models.

🏖️ Benefícios

• Full-coverage health insurance — medical, dental and vision — for you and your dependents • $1,000 home office equipment stipend • $1,200/year learning budget for books, courses, etc. • $250/month wellness budget for gym, cleaners, spa, food, etc. • All 3-day weekends are turned into 4-day weekends 🎉 • Unlimited vacation and paid holidays • Paw-ternity leave — adopt a dog and get a day off with your new family member 🐶 • Competitive salary • Company equity options grant for new hires