Director, Global Companion Diagnostics Leader in Basking Ridge, NJ at DSI

Date Posted: 3/26/2020

Job Snapshot

Job Description

Join a Legacy of Innovation 110 Years & Counting!

With over 100 years of scientific expertise & a presence in more than 20 countries, Daiichi Sankyo & its 15,000 employees around the world draw upon a rich legacy of innovation & a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension & thrombotic disorders, under the Group’s 2025 Vision to become a “Global Pharma Innovator with a Competitive Advantage in Oncology,” Daiichi Sankyo research & development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart & kidney diseases, & other rare diseases.

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.

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, manages CDx development activities and deliverables in collaboration 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 landscape

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/Experience:
  • PhD in Life Sciences or MD PhD in relevant discipline preferred, or MS degree
  • Minimum of 6 years relevant work experience with PhD/MD PhD
  • MS with at least 8-10 years of relevant experience will also be considered
  • Demonstrated track record of success working on multidisciplinary pharmaceutical /diagnostic development teams
  • Understanding of the IVD Development Process, with direct experience with Companion Diagnostics Development
  • Broad knowledge and understanding of established and new assay technologies such as NGS, IHC, PCR
  • Experience with CDx regulatory submissions to the FDA and other health authorities globally
  • Knowledge of drug development process and a strong understanding of how diagnostic development can shape drug development and commercialization, especially in oncology, is strongly preferred
  • Ability to work in a highly collaborative environment globally with stakeholders from multiple functional areas
  • Strong strategic and analytical skills with a proven ability to define, prioritize and balance responsibilities in accordance with business and team needs
  • Experience defining and maintaining strategic direction while ensuring successful execution of project details
  • Solid interpersonal and verbal and written communication skills with the ability to effectively communicate with individuals at all levels in 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.