Director, CDx Development

🕒 Julho 15

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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

• Lead the development and execution of integrated CDx strategies across clinical development programs, ensuring alignment with overall drug development objectives and timelines. • Engage early with Translational Discovery and Research teams to understand predictive hypotheses and biomarker strategies for pipeline programs. • Partner with internal research teams and external vendors to develop predictive assays when suitable assays are not already available. • Define and advance CDx strategies through internal governance bodies, securing timely alignment and endorsement. • Collaborate cross‑functionally to define Diagnostic Target Product Profiles and identify optimal diagnostic platforms and CDx partners. • Work closely with Regulatory Affairs to support the preparation and submission of regulatory documentation (e.g., IDEs, PMAs) and to interact with global health authorities as needed. • Oversee CDx development activities to ensure on‑time delivery of diagnostic kits to support pharmaceutical registration and commercial launch. • Provide clear, proactive communication to cross‑functional stakeholders on CDx program progress, risks, and mitigation strategies. • Monitor and interpret emerging industry trends, technology advancements, and evolving regulatory requirements related to IVDs and companion diagnostics.

🎯 Requisitos

• PhD with a minimum of 5+ years of industry experience in clinical biomarker testing and companion diagnostics development • Strong scientific and technical expertise in clinical development, biomarker strategies, and regulatory requirements for IVD and CDx products • Hands-on knowledge of diagnostic platforms such as NGS, IHC, FISH, and related technologies • Proven ability to lead complex, cross-functional programs to completion on time and within budget • Strong analytical and strategic thinking skills, with the ability to make data-driven decisions in ambiguous or complex situations and to think at a portfolio level • Demonstrated ability to influence and align stakeholders across development and commercial organizations without direct authority • Excellent communication skills, with the ability to convey complex scientific and strategic concepts clearly to both technical and non-technical audiences • Experience working effectively in a matrixed environment and leading cross-functional teams.

🏖️ Benefícios

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