BeOne is hiring a Director CDx Development

BeOne is hiring a Director CDx Development to define and execute end-to-end companion diagnostic strategies. You will drive these strategies in alignment with clinical development programs and timelines, partnering closely with internal teams and external IVD collaborators to enable precision medicine.

What You'll Do

• Lead the development and execution of integrated CDx strategies across clinical development programs.
• 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 when needed.
• Define and advance CDx strategies through internal governance bodies for alignment and endorsement.
• Collaborate cross-functionally to define Diagnostic Target Product Profiles and identify optimal diagnostic platforms and partners.
• Work closely with Regulatory Affairs to support the preparation and submission of regulatory documentation and interact with global health authorities.
• 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.
• Contribute to broader training, leadership, and management activities as required.

What We're Looking For

• PhD with a minimum of 5+ years of industry experience in clinical biomarker testing and companion diagnostics development, with a record of successful drug and/or IVD approvals.
• 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.
• 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.

Technical Stack

• NGS
• IHC
• FISH

Benefits & Compensation

• Compensation: $176,600.00 - $236,600.00 annually + equity: Eligible for discretionary equity awards
• Medical, Dental, Vision insurance
• 401(k)
• FSA/HSA
• Life Insurance
• Paid Time Off
• Wellness programs
• Eligibility for Employee Stock Purchase Plan

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.