CDx Strategy Lead | Companion Diagnostics Director

Daiichi Sankyo; Basking Ridge (NJ); On-site; USD 167,000 - 250,000; Full time

Job summary

Daiichi Sankyo is seeking an Associate Director, Companion Diagnostics Leader to help develop and implement CDx strategy within Early and Late-Stage Development. The role focuses on enabling precision medicine by driving diagnostic programs aligned with therapeutic projects.

The role requires strong collaboration across Global Project Teams, Translational Science, Clinical Biomarker and Regulatory teams, with extensive regulatory and data-collection responsibilities for CDx submissions.

Qualifications

• BS/BA required; MS/PhD preferred.
• Minimum years of experience: 4+ with PhD; 7+ with MS; 11+ with BS/BA.

Responsibilities

• Contributes to CDx project teams from assay development to approval and launch.
• Collaborates cross-functionally to ensure data collection and regulatory submissions.
• Oversees clinical sample testing activities and data capture for regulatory submissions.
• Provides scientific and technical expertise with Translational Science Leads and Regulatory Liaisons.
• Supports Regulatory affairs content review for CDx submissions to FDA and other authorities.

Skills

Collaboration

Strategic thinking

Communication

Project management

Education

BS/BA

MS or PhD preferred

Tools

NGS

IHC

PCR

Job description

Daiichi Sankyo is seeking an Associate Director, Companion Diagnostics Leader to help develop and implement CDx strategy within Early and Late-Stage Development. The role focuses on enabling precision medicine by driving diagnostic programs aligned with therapeutic projects.

The role requires strong collaboration across Global Project Teams, Translational Science, Clinical Biomarker and Regulatory teams, with extensive regulatory and data-collection responsibilities for CDx submissions.