Senior Director, Companion Diagnostics Strategy Lead

3 weeks ago


Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full time
About the Role

We are seeking a highly skilled and experienced professional to lead our Companion Diagnostics efforts in support of our Early and Late-Stage Development Portfolio.

As a key member of our team, you will play a critical role in guiding the strategy and implementation of Companion Diagnostics, working closely with our Global Program Teams, Translational Science Leads, Clinical Biomarker Leads, Biosample Operations, Clinical Leads, and Regulatory Liaisons.

Key Responsibilities
  • Contribute 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.
  • Contribute to CDx Partner evaluation and selection activities and manage multiple Companion Diagnostics Partnerships with Diagnostic Partner.
  • Provide scientific and technical expertise by collaborating closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations, Clinical Leads, and Regulatory Liaisons to ensure successful implementation of CDx and data collection.
  • Support 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, execute 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.
Requirements
  • PhD in Life Sciences or in related discipline preferred.
  • Minimum 3 years relevant work experience with PhD or 5+ years relevant work experience with MS.
  • Demonstrated track record of success working on multidisciplinary pharmaceutical /diagnostic development teams.
  • Broad knowledge and understanding of established and new assay technologies such as NGS, IHC, PCR etc.
  • Experience maintaining strategic direction while ensuring successful execution of project details.
  • Solid interpersonal and verbal and written communication skills with the ability to effectively communicate within project teams and at managerial levels of the organization across various functions and locations.

Daiichi Sankyo, Inc. is an equal opportunity employer and welcomes applications from diverse candidates. We provide employees with the training, tools, and technology they need to excel in their roles and contribute to our mission of improving patient outcomes through innovative pharmaceutical therapies.



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