Director, Safety Physician

🕒 Agosto 25

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $190.000 - $237.000 / ano

⏰ Tempo Integral

🔴 Especialista

👔 Diretor

👻 Score fantasma 15%

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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Summit Therapeutics, Inc.

SiteLinkedInTodas as Vagas

201 - 500 funcionários

Fundada em 2003

🏥 Saúde

💼 Consultoria

📣 Marketing

🔥 Investimento no último ano

💰 $500.000.000 Post-IPO Equity - Summit Therapeutics em 2025-10

Healthcare • Consulting • Marketing

A Summit Therapeutics, Inc. é uma empresa biofarmacêutica especializada em oncologia, focada na descoberta, desenvolvimento e comercialização de novas terapias medicinais para melhorar a qualidade e a duração de vida de pacientes com necessidades médicas não atendidas. A empresa está avançando com o ivonescimab (SMT112), um novo anticorpo biespecífico que tem como alvo PD-1 e VEGF, através de múltiplos ensaios clínicos de Fase 3 para o câncer de pulmão de não pequenas células e outros tumores sólidos sob licença da Akeso. A Summit enfatiza o desenvolvimento clínico, estratégias de registro regulatório e potencial comercialização em seus territórios licenciados enquanto promove opções de tratamento que beneficiam tanto pacientes quanto cuidadores.

Descrição

• Provide medical oversight of individual case safety reports (ICSRs) for investigational and marketed products. • Contribute strategically to adverse event monitoring and signal detection. • Support compliance with global pharmacovigilance regulatory requirements. • Lead medical review of ICSRs, including narratives, coding, expectedness, causality, and seriousness assessments. • Prepare Analyses of Similar Events (AOSEs) for IND safety reports. • Confirm criteria and content for expedited safety reporting and unblinding decisions, including SUSARs and urgent safety issues. • Prepare and present safety information for safety committees, monitoring committees, and stakeholders. • Review study protocols for safety content and overlapping toxicities. • Liaise with pharmacovigilance vendor medical reviewers and Medical Monitors. • Review individual and aggregate safety data to support signal detection. • Lead assigned product or therapeutic areas. • Identify ICSR quality issues and support quality assurance activities. • Implement case follow-up and query activities according to SOPs. • Develop medical coding conventions and process improvements. • Support reconciliation between Safety and Clinical databases. • Maintain and approve expected terms in Reference Safety Information. • Lead Medical Safety Review processes and support training and implementation. • Mentor and manage Safety Physicians and Medical Safety Reviewers as assigned. • Maintain inspection readiness and act as contact for health authority inspections and internal audits. • Provide expertise for process improvement, standards, SOPs, and medical safety metrics. • Author, review, or approve aggregate safety documents including DSURs, PBRERs, regulatory responses, and safety signal evaluations.

🎯 Requisitos

• MD, DO, or international equivalent with a minimum of 10 years of relevant experience as a safety physician. • Working knowledge of case management and medical review processes and procedures. • Clinical knowledge of oncology patient populations and relevant drug classes, including immunotherapy and chemotherapy; oncology experience is preferred. • Proficiency with safety database systems, strong computer skills including spreadsheet and signal detection programs. • Strong understanding of global safety reporting and pharmacovigilance requirements, aggregate reporting, and signal detection for clinical trial and post-marketing safety. • Experience analyzing safety data and writing study-related narratives, aggregate reports, and safety assessments. • Experience working effectively independently and in cross-functional team environments. • Experience with MedDRA coding and search strategies. • High level of attention to detail, accuracy, and confidentiality. • Clear, concise oral and written communication skills. • Excellent organizational, critical thinking, and problem-solving skills. • Ability to manage multiple priorities, including time-sensitive and highly confidential documents. • Ability to communicate complex ideas clearly and effectively to varied audiences. • Ability to prioritize competing demands. • Ability to work successfully in a fast-paced, demanding, and collaborative environment.