Director, Translational Biomarkers

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 120 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. 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 in Translational Biomarkers within the Translational Science and Biomarkers department of the Global Precision Medicine Function. The primary responsibilities of this position are to ensure the timely execution of biomarker tests on samples from clinical trials and to perform technical and strategic assessment of new and innovative biomarker platforms. This position requires knowledge in cancer biology, broad technical expertise, and direct experience in biomarker assay development/validation and oversight at external CROs and specialty labs and involves working in a global matrix of biomarker and translational scientists and clinical operations. The candidate must have effective project management skills and communicate progress and risks toward the timely testing of biomarkers in clinical development programs. The individual will be directly involved in collaborating globally (mainly US and Japan) with biomarker scientists, translational science leads and clinical development staff in the timely deployment of high-quality biomarkers analysis on clinical samples.

Responsibilities:           

• Independent contributor in the development, transfer and execution of biomarker assays for clinical development including: 1) identify  appropriate biomarker tests and technology solutions in DS wet labs, contract research organizations, and specialty labs  for DS clinical trials;  2) provide input 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 3) operationalize biomarker tests and ensure results are delivered and archived per clinical development needs.                                    

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

• Collaborate with Translational Scientists, Companion Diagnostic Scientists and Clinical Scientists and Operations Leads in the 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.                                   

• Contribute to propose, establish, and optimize more productive standardized working processes for clinical biomarker assay development and support.                                   

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

Education:

• PhD in biological sciences or related field with 10 or more years of industry experience post degree. Candidates must be experienced in oncology drug development.

Experience:

• Must have at least 5 years' experience in fit-for-purpose clinical biomarker assay development, validation, and implementation in support of multi-site clinical trials. Global implementation experience is highly desirable.

• Must have experience overseeing the establishment of biomarker assays at CROs in a GLP, GLP-like or CLIA environment.

• Experience and expertise in spatial platforms (e.g. mIHC, imaging mass cytometry, spatial transcriptomics) is desirable.

• A strong preference for a candidate with broad technical knowledge and experience analyzing complex data.

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

• Strong communication and presentation skills. Strong interpersonal skills and knowledge of intercultural differences.

• Ability to adjust priorities in a fast-paced environment.

• Strong organizational and networking skills.

Travel:

• Must be able to travel domestically and internationally 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.