CDx Strategy Lead for Precision Diagnostics

BeiGene, Ltd.; United States; Remote; USD 176,600 - 236,600; Full time

Benefits offered by this job

Equity awards

Annual bonus plan

Stock Purchase Plan

Medical, dental, vision

401(k)

Paid Time Off

Job summary

BeOne Medicines Ltd. seeks a Companion Diagnostics (CDx) Lead to define and execute end-to-end diagnostic strategies aligned with clinical programs. You will partner with research, regulatory, and commercial teams and external IVD collaborators to enable precision medicine and successful regulatory approvals.

You will lead integrated CDx strategies, engage translational teams, and oversee development activities to ensure on-time delivery of diagnostic kits for registration and launch.

Qualifications

• PhD with 5+ years of industry experience in clinical biomarker testing and companion diagnostics development.
• Strong scientific/technical expertise in clinical development and regulatory requirements for IVD/CDx.
• Hands-on knowledge of diagnostic platforms such as NGS, IHC, FISH.
• Ability to lead complex cross-functional programs to completion on time and within budget.
• Excellent communication skills for technical and non-technical audiences.

Responsibilities

• Lead end-to-end CDx strategies aligned with clinical development timelines.
• Engage translational discovery teams to understand biomarker strategies.
• Partner with researchers and vendors to develop predictive assays.
• Advance CDx strategies through governance and alignment.
• Collaborate to define Diagnostic Target Product Profiles and CDx platforms.
• Support regulatory submissions and interact with health authorities.
• Oversee CDx development to ensure timely delivery of diagnostic kits.

Skills

Biomarker strategies

Regulatory requirements

NGS

IHC

FISH

Cross-functional leadership

Data-driven decisions

Clear communication

Education

PhD

Tools

NGS platform

IHC

FISH

Job description

BeOne Medicines Ltd. seeks a Companion Diagnostics (CDx) Lead to define and execute end-to-end diagnostic strategies aligned with clinical programs. You will partner with research, regulatory, and commercial teams and external IVD collaborators to enable precision medicine and successful regulatory approvals.

You will lead integrated CDx strategies, engage translational teams, and oversee development activities to ensure on-time delivery of diagnostic kits for registration and launch.