Beigene

Director CDx Development

Remote (US) · Director

Sponsorship not specified$177k-$237kDetected 6 days ago

Data AnalysisFDA RegulatoryNGSResearchLeadershipCommunicationProblem SolvingRegulatory Affairs

About the role

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.
Packages may vary by location due to differences in the cost of labor.

Lead the development and execution of integrated CDx strategies across clinical development programs, ensuring alignment with overall drug development objectives and timelines.
Partner with internal research teams and external vendors to develop predictive assays when suitable assays are not already available.
Collaborate cross‑functionally to define Diagnostic Target Product Profiles and identify optimal diagnostic platforms and CDx partners.
Oversee CDx development activities to ensure on‑time delivery of diagnostic kits to support pharmaceutical registration and commercial launch.

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.
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.

$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.
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.

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.
The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
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.

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.

This listing is sourced directly from Beigene's careers page and normalized into a canonical job model.