Associate Director, Companion Diagnostics Lead

Company: Daiichi Sankyo
Location: Basking Ridge
Posted on: November 25, 2022

Job Description:

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 15,000 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.SummaryThe 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.Responsibilities

• Leads CDx project teams for the diagnostic, in full alignment with Global Program Teams (GPT) for the therapeutic, covering all areas from CDx assay development through CDx approval and launch
• Leads 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 Liasions 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
• Creates a forward-looking Diagnostic development strategy while keeping abreast of regulatory and policy updates in the external environment and by tracking and understanding the competitive landscapeQualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.Education Qualifications (from an accredited college or university)
  • Master's Degree in life sciences or
  • PhD in life sciencesExperience Qualifications
    • 4 or More Years relevant work experience w PhD
    • 4 or More Years w/MS preferred
    • Demonstrated track record of success working on multidisciplinary pharmaceutical /diagnostic development teams preferred
    • Understanding of the IVD Development Process, with direct experience with Companion Diagnostics Development preferred
    • Broad knowledge and understanding of established and new assay technologies such as NGS, IHC, PCR etc. preferred
    • Knowledge of drug development process and a strong understanding of how diagnostic development can shape drug development and commercialization preferredTravelAbility to travel up to 20% Domestic and international travel may be required 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.

Keywords: Daiichi Sankyo, Newark , Associate Director, Companion Diagnostics Lead, Executive , Basking Ridge, New Jersey