Executive Director, Global Medical Affairs – Companion Diagnostic Lead

🕒 Julho 8

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

BeOne Medicines

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 2010

🧬 Biotecnologia

🏥 Saúde

💊 Farmacêutico

Biotechnology • Healthcare • Pharmaceuticals

A BeOne Medicines é uma empresa global de oncologia, com sede na Suíça, que descobre e desenvolve tratamentos inovadores mais acessíveis e com maior disponibilidade para pacientes com câncer em todo o mundo. Com um portfólio que abrange hematologia e tumores sólidos, a BeOne está acelerando o desenvolvimento de seu diversificado pipeline de novas terapias por meio de capacidades internas e colaborações. Com uma equipe global em crescimento, formada por mais de 11.000 colaboradores presentes em seis continentes, a empresa está comprometida em melhorar radicalmente o acesso a medicamentos para muito mais pacientes que deles precisam.

Descrição

• Develop a Global CDx medical Affairs Strategy • Support and implement cross-functional plan for successful CDx launch programs • Generate clinical and real-world evidence (eg IITs, testing utilization studies, diagnostic accuracy studies, clinical utility studies) • Work closely with GMA disease lead to integrate the CDx strategy with the overall Medical Strategy. • Lead and oversee any data generation efforts utilizing LDTs of follow-on CDx testing, aligning with overall global CDx strategy. • Provide global (inclusive of regional) insights into pipeline programs requiring CDx • Engage key opinion leaders (KOLs) in pathology and oncology to ensure successful launch of CDx • Cross-functional support of market launch readiness, aligning with commercial CDx activities. • Engage in feedback and advice from KOLs (oncologists and pathologists) on minimizing barriers and optimizing utilization of CDx, as well as validate future data generation needs. • Internal training of medical teams and field teams, with right-size training on CDx. • Support scientific publications • Provide medical review of diagnostic materials (PRC, MRC etc) • When appropriate be the GMA representative at Alliance partnerships • Develop, track, execute and report on goals and objectives. • Support budget planning and management. • Be accountable for compliant business practices.

🎯 Requisitos

• Advanced degree (MD, PharmD, PhD, or MD equivalent) with subspecialty training in oncology. • Extensive experience in pharma/biotech in solid tumors is required. • 8 plus years of experience within other biotech/pharmaceutical company. • Clinical solid tumor oncology experience and former CDx medical experience is mandatory for this role. • Previous experience in Medical Affairs in a CDx role is strongly preferred. • Expert understanding of incorporation of biomarker and development of CDx in a global clinical study. • Deep understanding of LDTs and extent of data generation to support launch of CDx and utilization of companion-drug. • High level of communication (written and verbal), interpersonal, organizational, and cross functional collaboration skills. • Knowledge of GCP and ICH Guidelines. • Flexibility to work with colleagues in a global setting. • Able to engage in work-related travel approximately 25%. • Strategic leader with demonstrated success building, managing and developing individuals and teams is preferred. • Experience with the development and support of related SOPs and policies is expected. • Knowledge of industry standard Clinical Development IT solutions expected.

🏖️ Benefícios

• Medical • Dental • Vision • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness