Director, Companion Diagnostics Operations Lead

Location
Basking Ridge, New Jersey
Posted
Jul 22, 2021
Ref
10967BR
Hotbed
Pharm Country
Required Education
Bachelors Degree
Position Type
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 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.

Summary

The Companion Diagnostics (CDx) Operations Lead will be responsible for establishing end to end process for Companion Diagnostics Operations implementation. The lead will ensure that sample testing and data generation activities are completed in alignment with the therapeutic and diagnostic team needs. The CDx Operations Lead will, in partnership with CDx, Clinical Operations and Biostatistics & Data Management, serve as the main facilitator of interactions between the external Diagnostics Partners, reference and specialty laboratories, and the internal Daiichi Sankyo collaborators and stakeholders. In addition, this position will have people management role and a leadership role in establishing the CDx Operations Lead team within CDx function.

Responsibilities
  • Develop strategy and implement processes for Companion Diagnostic Operations across the therapeutic portfolio
  • Create and oversee process for clinical trial sample testing activities and data capture to support CDx development regulatory submission
  • Partner with clinical biomarker lead for implementation of clinical trial assays at Diagnostics Partners, reference labs and specialty testing vendors
  • Develop and implement a quality assurance and QC monitoring program, ensure consistent data monitoring and output across the asset portfolio, and aligned CDx partners
    Implement procedures which will enable identification of issues and discrepancies, create mitigation strategies and preventive actions
  • Facilitate the development and implementation of standardized template requisition forms, scoring forms, and master DTS templates across all oncology clinical studies with CDx
  • Improve efficiencies in study setup and testing startup through standardization of sample management and data capture
  • Lead a small group of CDx Operations Managers

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

Education Qualifications (from an accredited college or university)

Bachelor's Degree The ideal candidate will have a degree in biological sciences or a related STEM discipline required or Master's Degree required PhD preferred or MBA MBA would be preferred as the individual will be responsible for process optimization of complex processes and relationships involving both internal and external business partners preferred
Experience Qualifications
  • 10 or More Years A BS or MS degree with 10+ years of relevant experience managing complex development projects required required or
  • 4 or More Years A PhD with 5+ years of work experience in pharmaceutical/diagnostics setting required and
  • Experience in Companion Diagnostics, Clinical Operations, Sample Management, Project Management preferred
  • Demonstrated track record of success working on a multidisciplinary pharma/diagnostic development team preferred

Travel
Ability to travel up to 20% Ability to travel up to 15%-20%

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.