CDx Strategy Leader (Associate Director)

Merck & Co.; Basking Ridge (NJ); On-site; USD 167,000 - 250,000; Full time

Job summary

Daiichi Sankyo, Inc. invites applications for a role focused on developing and implementing companion diagnostics (CDx) strategy within Global Project Teams.

You will collaborate across functions to support CDx assay development through regulatory submission and launch, helping to bring precision medicine to patients likely to benefit from our therapies. The position emphasizes cross-functional collaboration, regulatory support, and staying current with CDx regulatory updates while working with

Qualifications

• Minimum 4 years relevant work experience with PhD; minimum 7 years relevant work experience 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 of established and new assay technologies such as NGS, IHC, PCR etc.
• Understanding diagnostic development can shape drug development and commercialization is a plus.

Responsibilities

• Contributes to CDx project teams for the diagnostic, under the direction of the GPT CDx representative for the therapeutic or under the guidance of the CDx portfolio leader.
• Assists CDx GPT representative by collaborating cross-functionally to ensure successful implementation of the CDx and data collection.
• Oversees clinical trial sample testing activities and data capture to support CDx regulatory submission or related drug submissions.
• Contributes to CDx Partner evaluation and selection activities and manages multiple Companion Diagnostics Partnerships.
• Provides scientific and technical expertise by collaborating with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations, Clinical Leads and Regulatory Liaisons.

Skills

NGS

IHC

PCR

CDx development

Education

BS/BA

MS/PhD preferred

Job description

Daiichi Sankyo, Inc. invites applications for a role focused on developing and implementing companion diagnostics (CDx) strategy within Global Project Teams.

You will collaborate across functions to support CDx assay development through regulatory submission and launch, helping to bring precision medicine to patients likely to benefit from our therapies. The position emphasizes cross-functional collaboration, regulatory support, and staying current with CDx regulatory updates while working with