[Hiring] Director CDx Development @BeiGene

Role Description

The Companion Diagnostics (CDx) Lead will be responsible for defining and executing end‑to‑end diagnostic strategies that are fully aligned with clinical development programs and timelines. This role partners closely with research, clinical, regulatory, and commercial teams, as well as external IVD collaborators, to ensure the successful development, regulatory approval, and launch of companion diagnostics that enable precision medicine.

• Lead the development and execution of integrated CDx strategies across clinical development programs, ensuring alignment with overall 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.

Qualifications

• 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.

Requirements

• Travel: Not required

Benefits

• Salary Range: $176,600.00 - $236,600.00 annually
• Participation in the annual bonus plan for Non-Commercial roles and incentive compensation plan for Commercial roles.
• Opportunity to own shares of BeOne Medicines Ltd. stock through discretionary equity awards and Employee Stock Purchase Plan.
• Comprehensive benefits package including Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

Company Description

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor.

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.

In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact [email protected].