Job Information
BeOne Medicines Director CDx Development in Emeryville, California
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
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.