Global Companion Diagnostics Strategy Lead

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

Job summary

Daiichi Sankyo US is seeking an experienced professional to lead the development and implementation of companion diagnostics (CDx) strategy within the Early and Late-Stage Development Portfolio. This role drives precision medicine by enabling CDx-enabled patient selection for therapeutics, spanning assay development to regulatory submissions.

The position requires deep expertise in IVD/CDx development, strong cross-functional collaboration, and experience with regulatory interactions.

Qualifications

• BS/BA required; MS/PhD preferred.
• Minimum 4 years relevant work experience with PhD; minimum 7 years with MS; or minimum 11 years relevant work experience with BS/BA required.
• Demonstrated track record of success on multidisciplinary pharmaceutical/diagnostic development teams.
• Understanding of the IVD Development Process, with indirect or direct experience with Companion Diagnostics Development.
• Broad knowledge and understanding of established and new assay technologies such as NGS, IHC, PCR etc.

Responsibilities

• Contributes to CDx project teams for the diagnostic, under the direction of the Global Program Teams (GPT) CDx representative for the therapeutic or under the guidance of the CDx portfolio leader, covering all areas from CDx assay development through CDx approval and launch.
• Assists CDx GPT representative by collaborating cross-functionally to ensure successful implementation of the CDx and associated data collection.
• Oversees clinical trial sample testing activities and data capture to support CDx regulatory submission or associated drug regulatory submissions.
• Contributes to CDx Partner evaluation and selection activities and manages multiple Companion Diagnostics Partnerships to develop, implement and gain regulatory approvals for CDx assays.
• May function as the main point of contact to the Dx partner for CDx project contracts.
• Supports CDx analytical and clinical validation studies in collaboration with Dx-partner.
• Provides scientific and technical expertise by collaborating closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations, Clinical Leads and Regulatory Liaisons.
• Supports Regulatory affairs in providing content and providing review of documents supporting CDx submissions to the FDA and other health authorities globally.
• For late-stage programs, executes the Diagnostic development strategy for a project under the direction of the GPT CDx representative while keeping abreast of regulatory and policy updates in the external environment and by tracking and understanding the competitive landscape.

Skills

Cross-functional collaboration

Strategic thinking

Communication skills

Project management

Education

BS/BA required

MS or PhD preferred

Tools

NGS

IHC

PCR

Job description

Daiichi Sankyo US is seeking an experienced professional to lead the development and implementation of companion diagnostics (CDx) strategy within the Early and Late-Stage Development Portfolio. This role drives precision medicine by enabling CDx-enabled patient selection for therapeutics, spanning assay development to regulatory submissions.

The position requires deep expertise in IVD/CDx development, strong cross-functional collaboration, and experience with regulatory interactions.