Job Overview
Location
Remote (US)
Job Type
Full-time
Category
Data Science
Date Posted
March 31, 2026
Full Job Description
đź“‹ Description
- • Lead the development and execution of integrated companion diagnostic (CDx) strategies across clinical development programs, ensuring alignment with drug development objectives and timelines.
- • Engage early with Translational Discovery and Research teams to understand predictive hypotheses and biomarker strategies for pipeline programs.
- • Partner with internal research teams and external vendors to develop predictive assays when suitable assays are not already available.
- • Define and advance CDx strategies through internal governance bodies, securing timely alignment and endorsement.
- • Collaborate cross‑functionally to define Diagnostic Target Product Profiles and identify optimal diagnostic platforms and CDx partners.
- • Work closely with Regulatory Affairs to support the preparation and submission of regulatory documentation (e.g., IDEs, PMAs) and to interact with global health authorities as needed.
- • 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 related to IVDs and companion diagnostics.
🎯 Requirements
- • PhD with a minimum of 5 years of industry experience in clinical biomarker testing and companion diagnostics development, with a demonstrated 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 and to think at a portfolio level.
- • 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.
🏖️ Benefits
- • Competitive salary range: $176,600.00 - $236,600.00 annually
- • Comprehensive benefits package including Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness
- • Opportunity to own shares of BeOne Medicines Ltd. stock through discretionary equity awards and Employee Stock Purchase Plan
- • Equal opportunity employer committed to fair and equitable compensation practices
- • Commitment to diversity, inclusion, and reasonable accommodation for individuals protected by applicable law
Skills & Technologies
About BeiGene, Ltd.
BeiGene is a global biotechnology company discovering, developing, manufacturing and commercializing innovative oncology medicines. Its broad pipeline includes more than 50 clinical-stage molecules, spanning targeted therapy, immuno-oncology and combination regimens. Core products are BTK inhibitor BRUKINSA, PD-1 antibody tislelizumab and PARP inhibitor pamiparib, marketed worldwide through internal teams and strategic alliances. BeiGene operates integrated research campuses in Beijing and Cambridge, MA, a manufacturing facility in Suzhou and offices across North America, Europe and Asia-Pacific, serving patients in more than 45 countries.
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