Associate Director, Clinical Biomarker

BeOne Medicines Ltd.; San Mateo (CA); On-site; USD 180,000 - 260,000; Full time

Job summary

BeOne Medicines Ltd. in California seeks an Associate Director of Clinical Biomarker & Translational Medicine for Oncology (Solid Tumor Portfolio, GI franchise) to provide strategic leadership across clinical biomarker initiatives, accelerating trials and pipeline progression.

The role requires PhD or MD/PhD with 5+ years in biotech/pharma biomarker science, expertise in assay development and validation, cross-functional leadership, and a proven track record in translational medicine, regulatory

Qualifications

• PhD or MD/PhD in a relevant discipline.
• 5+ years in pharma/biotech biomarker science in oncology.
• Proven leadership in translational medicine with regulatory submissions.
• Experience managing cross-functional and cross-institutional teams.
• Mandarin language proficiency is required.

Responsibilities

• Lead global clinical biomarker strategy for solid tumor oncology with cross-functional teams.
• Oversee biomarker assay development and validation for regulatory readiness.
• Analyze biomarker data to inform go/no-go decisions and trial advancement.
• Communicate biomarker insights and strategy recommendations to stakeholders.
• Mentor junior scientists and project teams; drive external partnerships.

Skills

Biomarker science

Oncology translational medicine

Cross-functional leadership

Regulatory submissions

Education

PhD or MD/PhD in relevant field

Job description

General Description:

We are seeking an Associate Director of Clinical Biomarker & Translational Medicine for Oncology (Solid Tumor Portfolio, GI franchise) to provide strategic, scientific, and operational leadership across our clinical biomarker initiatives for solid tumor oncology programs. This role is pivotal in driving the development and execution of innovative biomarker strategies that accelerate our clinical trials and pipeline advancement.

Essential Functions of the Job:

• Lead global clinical biomarker strategy for solid tumor oncology, in partnership with cross-functional teams, ensuring effective design and implementation of biomarker and companion diagnostic initiatives throughout the drug development continuum.
• Oversee biomarker assay development and validation, including scientific input on assay design, proficiency testing, and analytical/clinical validation, ensuring readiness for regulatory and clinical decision points.
• Direct the comprehensive analysis and interpretation of biomarker data to inform go/no-go decisions and trial advancement.
• Effectively communicate with internal and external stakeholders, translating biomarker data into tangible insights and strategy recommendations.
• Serve as scientific leader and subject matter expert, actively contributing to scientific discussions, program strategy, and the advancement of clinical stage projects.
• Drive and manage external partnerships with academic institutions, CROs, and industry partners to enhance biomarker discovery and development efforts.
• Contribute to regulatory submissions related to biomarker strategies and companion diagnostics.
• Champion biomarker-related publications, driving thought leadership and innovation in oncology drug development.

Supervisory Responsibilities:

• Not required

Requirements:

• PhD or MD/PhD in a relevant scientific discipline, with 5+ years’ experience in pharmaceutical or biotechnology settings, focusing on biomarker science in oncology.
• Deep expertise in biomarker discovery, clinical assay development, and validation (including proficiency in designing and analyzing biomarker-driven clinical trials). Strong experience in pe-clinical oncology research and drug discovery.
• Demonstrated leadership in translational medicine, with a track record of successful biomarker strategies leading to regulatory submissions, approvals, or high-impact publications.
• Experience managing cross-functional and cross-institutional teams.
• Excellent communication, reporting, and presentation skills.
• Proven ability to thrive in dynamic, fast-paced environments and to mentor junior scientists and project teams.
• Strong publication record and/or regulatory contributions in oncology clinical development.
• Mandarin language proficiency is required.

Travel:

• Not required

Education Required:

PhD or MD/PhD in a relevant scientific discipline.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.