Manager, CDx Diagnostics Scientist

Join a Legacy of Innovation 125 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 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, 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:

This position resides within the Functional Excellence and Clinical Biomarker Oncology department of the Global Precision Medicine function. The Manager, CDx Diagnostics Scientist's primary responsibilities are:

• Assists in defining the biomarker assessment and implementation plan for clinical trials.

• Executes biomarker testing and data capture at central and analytical labs for clinical trials. Supports the development and implementation of standardized template requisition forms, scoring forms, and Data Transfer documents.

• Supports technical and strategic assessment of new innovative biomarker technology platforms.

• Supports the oversight of the end-to-end lifecycle of biomarker biosamples in clinical trials from study start-up to close-out, ensuring that samples are collected, used, stored or disposed of appropriately per the associated study Informed Consent Forms

• Performs data monitoring and supports data review procedures to help identification of issues and discrepancies and supports creation of mitigation strategies, preventive actions. The candidate must have effective project management skills and communicate progress and risks toward the timely testing of biomarkers in clinical development programs. The role is expected to work in close collaboration with several cross-functional internal and external stakeholders including but not limited to Translational Science, Companion Diagnostics, Biosample Management, Clinical Study Teams, Central & Analytical Laboratories and Clinical CROs for the timely deployment of high-quality biomarkers analysis on clinical samples.

Responsibilities:

• Supports the development and implementation plan of clinical biomarker assays at analytical labs including identification of appropriate biomarker tests and technology solutions in DS internal labs and external analytical labs for clinical trials.

• Collaborate with CDx Leads, Translational Science Leads, Biomarker Leads and other stakeholders globally in the evaluation and development of clinical biomarker assays and vendor selection for Daiichi Sankyo projects. Effectively identify, manage, and communicate risks to stakeholders in a clear and timely fashion.

• Executes the prospective and exploratory biomarker testing and data capture for clinical trials.

• Supports the development and implementation of standardized template requisition forms, scoring forms, and Data Transfer documents.

• Review of clinical protocols, laboratory instructions, investigator training, clinical sample analysis, archiving of biomarker test results, and regulatory submission activities for Daiichi Sankyo clinical development.

• Contributes on biomarker related sections of clinical study protocols and ensure instructions on sample collection, processing and shipping requirements are translated into SOWs and lab manuals; and operationalize biomarker tests and ensure results are delivered and archived per clinical development needs.

• Supports the planning and coordination of activities required to manage the lifecycle of biosamples (e.g., collection, shipping, tracking, processing, analysis, data delivery and cleaning, and final sample disposition).

• Review the Clinical CRO Sample Management Plan, to document cross-functional agreements on the tracking, lifecycle and reconciliation plan for each sample type. Support resolution of biosample-related sample/data reconciliation and sample related risks/issues at sites, Central labs or analysis labs in collaboration with relevant stakeholders.

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

Education:

• PharmD or PhD in biological sciences or related field with 2 or more years of industry experience post degree required.

Experience:

• 1+ years of experience in fit-for-purpose clinical biomarker assay development, validation, or implementation in support of multi-site clinical trials required

• Experience in oncology drug development preferred

• Experience overseeing the Clinical trial study conduct of biomarker assays at CROs in a GLP, GLP-like or CLIA environment preferred

• Basic knowledge of clinical trial design; understanding of the overall drug development process preferred

• Experience with tracking of prospective biomarkers sample during study conduct preferred

• Technical knowledge and experience analyzing complex data preferred

• Excellent organizational and communication skills

• Ability to work independently as well as collaboratively in an international matrixed team environment.

• Proven networking skills and ability to share knowledge and experience amongst colleagues.

• Ability to manage multiple competing priorities and meet timelines in a fast-paced environment required

Travel:

• Ability to travel up to 10%

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.