Director CDx Development
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Job Description
Director of Companion Diagnostics at BeOne developing integrated diagnostic strategies for clinical programs. Collaborating with research and regulatory teams to ensure successful diagnostics development.
Responsibilities:
- 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.
Requirements:
- PhD with a minimum of 5+ years of industry experience in clinical biomarker testing and companion diagnostics development
- 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:
- Medical
- Dental
- Vision
- 401(k)
- FSA/HSA
- Life Insurance
- Paid Time Off
- Wellness
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