Associate Director, Companion Diagnostics Lead

4 weeks ago

Basking Ridge, New Jersey, United States BioSpace, Inc. Full time
Job Summary

The Associate Director, Companion Diagnostics Lead will play a key role in guiding the strategy and leading the implementation of companion diagnostics (CDx) in support of projects within Daiichi Sankyo's Early and Late-Stage Development Portfolio.

This position will 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.

The individual will collaborate closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations, Clinical Leads, and Regulatory Liaisons to ensure successful implementation of CDx and data collection.

Responsibilities include contributing to CDx Partner evaluation and selection activities, managing multiple Companion Diagnostics Partnerships with Diagnostic Partners, and providing scientific and technical expertise.

The Associate Director, Companion Diagnostics Lead will also support Regulatory affairs in providing content and reviewing documents supporting CDx submissions to the FDA and other health authorities globally.

For late-stage programs, the individual will 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.

Qualifications:

  • PhD in Life Sciences or in related discipline preferred.
  • MS degree in Life Sciences or in related discipline required.
  • 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.
  • 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.
  • Knowledge of drug development process and an understanding of how diagnostic development can shape drug development and commercialization is strongly preferred.

Competencies:

  • Ability to work in a highly collaborative environment globally with stakeholders from multiple functional areas.
  • Strategic and analytical skills with a proven ability to define, prioritize, and balance responsibilities in accordance with business and team needs.
  • 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.

Domestic and international travel may be required: 15%

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