Director, Clinical 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 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. 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 is within the Clinical Biomarker Analysis group that resides in the Department of Translational Sciences. This position requires significant knowledge in cancer biology and signaling pathways, oncology clinical development, broad technical expertise, and direct experience in biomarker assay development, validation, and data quality at external specialty labs and contract research organizations. The primary responsibilities of this position are to oversee biomarker assay development, validation, sample and data analysis conducted in laboratories internal and external to Daiichi Sankyo for all stages of drug development. 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 with biomarker scientists (Japan), translational science leads (US) and clinical development staff (US and Japan) in the timely deployment of high quality biomarkers tests on clinical samples.

Responsibilities:

Independent contributor in the development and preparation of biomarker assays for clinical development including: 1) identify appropriate biomarker tests, technology solutions, sample processing, and CRO and specialty labs for Cancer Enterprise clinical trials and programs; 2) provide input on biomarker related sections of clinical study protocols including the necessary sample collection, processing and shipping requirements; and 3) evaluate, interpret and present complex scientific data in support of global biomarker driven oncology clinical trials at all stages of drug development.

Collaborate with Translational Science leads in the US and Biomarker Science leads in Japan in the evaluation and development of clinical biomarker assays and testing sites for early and late stage Cancer Enterprise projects. Effectively identify, manage and communicate risks to stakeholders in a clear and timely fashion.

Collaborate with Biomarker Leads, Companion Diagnostic Leads and Clinical Operations and Development Leads in the review of laboratory instructions, delivery of samples, analysis and archiving of biomarker test results for Cancer Enterprise clinical development.

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

Education/Experience:

• 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.
• Must have at least 6 years' experience in fit-for-purpose clinical biomarker assay development, validation and implementation in support of multisite 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.
• A strong preference for a candidate with broad technical knowledge and experience analyzing complex data.
• Ability to work independently as well as collaboratively in a matrixed team environment.
• Strong oral/written and interpersonal skills required.
• Ability to adjust priorities in a fast-paced environment.
• Strong organizational and networking skills.

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.

Job Title
Director, Clinical Biomarkers

City
Basking Ridge

Functional Area
Global Oncology R&D

State
New Jersey