Director CDx Development at BeiGene

, , United States -

Full Time

Start Date

Immediate

Expiry Date

01 Aug, 26

Salary

236600.0

Posted On

03 May, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Companion diagnostics, Clinical development, Biomarker strategy, Regulatory affairs, NGS, IHC, FISH, Strategic planning, Cross-functional leadership, Data-driven decision making, Regulatory submission, Project management, Stakeholder management, Oncology, Precision medicine

Industry

Biotechnology Research

Description

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. General 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. Essential Functions of the Job: 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. Supervisory Responsibilities: Contribute to broader training, leadership, and management activities as required. 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. Travel: Not required Global Competencies When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial Mindset Continuous Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial Excellence Communicates with Clarity Salary Range: $176,600.00 - $236,600.00 annually 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. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness. 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 accommodationsus@beonemed.com. BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 11,000 colleagues spans six continents. To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn, X (formerly known as Twitter), Facebook and Instagram. For more information, please visit the link to explore job opportunities in China Mainland. China Mainland Job Posting At BeOne, how we work is just as important as the work we do. Below are our Values that determine the decisions we make and how we do things. Patients First Driving Excellence Bold Ingenuity Collaborative Spirit

Responsibilities

The CDx Lead defines and executes end-to-end diagnostic strategies aligned with clinical development programs and regulatory requirements. This role collaborates with internal research, clinical, and commercial teams, as well as external partners, to ensure the successful development and launch of companion diagnostics.