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Associate Director, Companion Diagnostics Lead

2 months ago

Basking Ridge, United States Daiichi Sankyo Full time

Join a Legacy of Innovation 110 Years and Counting

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

Job Summary

The primary responsibilities of this position are to guide the strategy and to lead the implementation of companion diagnostics (CDx) in support of projects within Daiichi Sankyo’s Early and Late-Stage Development Portfolio. The individual will play a key role in making Precision Medicine a reality for patients who are likely to benefit from our therapeutics.

  • 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. May act as CDx representative to GPT for early-stage programs.
  • Contributes to CDx Partner evaluation and selection activities and manages multiple Companion Diagnostics Partnerships with Diagnostic Partner
  • Provides 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
  • 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

    Domestic and international travel may be required: 15%

    Qualifications: (What are the minimum requirements for the position?)

    Education:

    • PhD in Life Sciences or in related discipline preferred.
    • MS degree in Life Sciences or in related discipline required.

      Experience:

      • 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

              Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.