Daiichi Sankyo Inc. Exec Dir Translation Science, Biomarker & Personalized Medicine 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.
Job Summary : This position will lead the incorporation of biomarker assays and companion diagnostics into clinical development and clinical testing. The role will require a strong understanding science and the ability to develop strategies for the personalization of candidate medicines. This is a highly visible position with ability to influence strategy, not only for particular products but also therapeutic areas.
Lead or assume a leadership role on multi-function and cross-regional teams charged with various aspects of personalized medicine and, specifically, a group responsible for biomarker development. Oversee planning for aspects of global trials involving biomarkers and biomarker analysis. Ensure that biomarker assays are compatible with clinical testing and emerging platform testing when appropriate. Interact with basic researchers (in Japan), charged with biomarker discovery, and provide leadership through influence and proven successful track record.
Oversee development of companion diagnostics, and ensure pathways for research/clinical trial assays to become companion diagnostic tests, as needed. Serve as in-house resource on the emerging companion diagnostics field. Ensure internal companion diagnostics are compatible with, and feasible for, incorporation in to normal clinical practice (and be consistent with commercial needs).
Oversee or lead interactions with clinical teams related to development of personalization and biomarker strategies - ensure adequate support (provide staffing and resource estimates, guidance, etc.) for implementing necessary work and support – especially in the area of oncology, but also in other therapeutic areas such as cardiometabolics.
Provide oversight and direction for wet-lab in Tokyo Translational Medicine & Clinical Pharmacology Department.
Provides leadership and expertise in devising analytic plans.
Serve as in-house expert on state of the art methodologies/technologies.
Establishes preferred laboratory providers; oversee or play key role in ensuring success of partnerships and collaborations with outside vendors.
Review and opine on regulatory strategies, documents and communications pertaining to lab-test and companion diagnostics.
Makes decisions on the adequacy of guidelines for assay validation and QC
Provides strategic contributions to portfolio; support assessment of business-development opportunities as necessary.
Education: PhD, MD/VMD (for pathology)
Experience: 10+ years industry experience with a focus on Biomarkers & Companion Diagnostics
Daiichi Sankyo, Inc., is an equal opportunity/affirmative action employer. All 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.
Exec Dir Translation Science, Biomarker & Personalized Medicine
R&D Global Oncology R&D