Global Medical Affairs CDx Lead – Strategy & Launch

BeOne Medicines; United States; Presencial; USD 297.000 - 377.000; Jornada completa

Descripción de la vacante

BeOne Medicines seeks an Executive Companion Diagnostic Lead to drive a global CDx medical affairs strategy and align with commercial CDx and Clinical Development. This role involves cross-functional leadership, budget awareness, and rigorous data generation to support CDx launch programs.

The incumbent will collaborate with global colleagues, engage KOLs, oversee LDT-based studies, and help ensure compliant business practices while enabling successful market access and scientific publication.

Formación

• Advanced degree (MD, PharmD, PhD) with oncology subspecialty.
• 8+ years in pharma/biotech with solid tumors experience.
• CDx medical affairs experience; CDx in Medical Affairs preferred.
• Deep understanding of biomarker incorporation and CDx in global studies.
• Strong written and verbal communication and cross-functional collaboration.

Responsabilidades

• Develop a Global CDx medical affairs strategy.
• Support cross-functional plan for successful CDx launch programs.
• Generate clinical and real-world evidence (IITs, testing utilization, diagnostic accuracy, clinical utility).
• Work with GMA disease lead to integrate CDx with overall Medical Strategy.
• Lead data generation using LDTs aligned with global CDx strategy.
• Provide global insights into pipeline programs requiring CDx.
• Engage KOLs in pathology and oncology to ensure CDx launch success.
• Cross-functional support of market launch readiness with commercial CDx activities.
• Provide medical review of diagnostic materials (PRC, MRC).
• Develop, track, execute and report on goals and objectives.

Conocimientos

Global Medical Affairs

Cross-functional leadership

CDx strategy

KOL engagement

Regulatory knowledge

Scientific communication

Educación

MD/PhD/PharmD with oncology

Herramientas

GCP knowledge

ICH Guidelines

Descripción del empleo

BeOne Medicines seeks an Executive Companion Diagnostic Lead to drive a global CDx medical affairs strategy and align with commercial CDx and Clinical Development. This role involves cross-functional leadership, budget awareness, and rigorous data generation to support CDx launch programs.

The incumbent will collaborate with global colleagues, engage KOLs, oversee LDT-based studies, and help ensure compliant business practices while enabling successful market access and scientific publication.