Companion Diagnostics Strategy Lead

BeiGene, Ltd.; United States; Remote; USD 177,000 - 237,000; Full time

Job summary

BeOne Medicines Ltd. is seeking a Companion Diagnostics (CDx) Lead to define and execute end-to-end diagnostic strategies aligned with clinical development programs.

You will partner with research, regulatory, and commercial teams to ensure the successful development, regulatory approval, and launch of CDx solutions. The role requires leadership of cross-functional CDx programs, hands-on expertise in platforms like NGS, IHC, and FISH, and a track record of regulatory success in biomarker

Qualifications

• PhD with 5+ years in clinical biomarker testing and companion diagnostics development.
• Strong scientific and technical expertise in clinical development and regulatory requirements for IVD/CDx products.
• Hands-on knowledge of diagnostic platforms such as NGS, IHC, FISH.
• Proven ability to lead complex cross-functional programs to completion on time and within budget.
• Excellent communication skills, with the ability to convey complex scientific concepts clearly.
• Experience working in a matrixed environment and leading cross-functional teams.

Responsibilities

• Lead the development and execution of integrated CDx strategies across clinical development programs, ensuring alignment with timelines.
• Engage early with Translational Discovery and Research teams to understand predictive hypotheses and biomarker strategies.
• Partner with internal research teams and external vendors to develop predictive assays.
• Define and advance CDx strategies through internal governance and secure alignment.
• Collaborate cross-functionally to define Diagnostic Target Product Profiles and identify CDx partners.
• Work with Regulatory Affairs to support regulatory documentation and interactions with authorities.
• Oversee CDx development activities to ensure on-time delivery of diagnostic kits.
• Provide clear communication to stakeholders on program progress, risks, and mitigation.
• Monitor emerging industry trends and regulatory requirements related to IVDs/CDx.

Skills

CDx strategy leadership

Cross-functional leadership

Analytical thinking

Regulatory awareness

Communication skills

Education

PhD with 5+ years in biomarker testing and CDx development

Tools

NGS

IHC

FISH

Job description

BeOne Medicines Ltd. is seeking a Companion Diagnostics (CDx) Lead to define and execute end-to-end diagnostic strategies aligned with clinical development programs.

You will partner with research, regulatory, and commercial teams to ensure the successful development, regulatory approval, and launch of CDx solutions. The role requires leadership of cross-functional CDx programs, hands-on expertise in platforms like NGS, IHC, and FISH, and a track record of regulatory success in biomarker