Daiichi Sankyo Inc. Director Clinical Biomarkers in Basking Ridge, New Jersey
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About Daiichi Sankyo Cancer Enterprise
The mission of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by three pillars including our investigational Antibody Drug Conjugate Franchise, Acute Myeloid Leukemia Franchise and Breakthrough Science, we aim to deliver seven distinct new molecular entities over eight years during 2018 to 2025. Our powerful research engines include two laboratories for biologic/immuno-oncology and small molecules in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA.
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.
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: (What are the minimum requirements for the position?)
Education and 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.
Director Clinical Biomarkers
R&D Global Oncology R&D