Senior CDx Development Lead for Precision Medicine

BeOne Medicines; United States; On-site; USD 176,600 - 236,600; Full time

Benefits offered by this job

Medical, Dental, Vision

401(k)

Equity awards

Employee Stock Purchase Plan

Job summary

BeOne Medicines is seeking a Companion Diagnostics (CDx) Lead to define and execute end-to-end diagnostic strategies aligned with clinical development programs and timelines. You will partner with research, regulatory, and commercial teams, as well as external IVD collaborators, to drive CDx development, regulatory approval, and launch for precision medicine.

You will lead cross-functional CDx programs, define Target Product Profiles, and oversee regulatory documentation while ensuring on-time

Qualifications

• PhD with 5+ years of industry experience in clinical biomarker testing and companion diagnostics development.
• Strong scientific and regulatory knowledge for IVD and CDx products.
• Hands-on experience with diagnostic platforms (NGS, IHC, FISH).
• Ability to lead cross-functional programs and influence stakeholders.

Responsibilities

• Lead end-to-end CDx strategies across clinical development programs.
• Collaborate with Translational Discovery, Research, Regulatory, and Commercial teams.
• Define Target Product Profiles and identify diagnostic platforms and partners.
• Support regulatory submissions and interactions with health authorities.
• Oversee CDx development activities to ensure on-time delivery.
• Communicate program progress, risks, and mitigation plans to stakeholders.
• Monitor industry trends and evolving regulatory requirements for IVDs.

Job description

BeOne Medicines is seeking a Companion Diagnostics (CDx) Lead to define and execute end-to-end diagnostic strategies aligned with clinical development programs and timelines. You will partner with research, regulatory, and commercial teams, as well as external IVD collaborators, to drive CDx development, regulatory approval, and launch for precision medicine.

You will lead cross-functional CDx programs, define Target Product Profiles, and oversee regulatory documentation while ensuring on-time