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.
The Associate Director, Clinical Biomarkers resides in Clinical Biomarkers function of Translational Sciences. This position requires knowledge in cancer biology, broad technical expertise, and direct experience in biomarker assay development and oversight at external CROs and specialty labs. The primary responsibility of this position is to ensure the timely execution of biomarker tests on clinical samples working in a global matrix of biomarker and translational scientists and clinical operations team. 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, 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 Cancer Enterprise 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 in the US and Biomarker leads in Japan in the evaluation and development of clinical biomarker assays and vendor selection 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 Scientists and Operations Leads in the review of clinical protocols, laboratory instructions, investigator training, clinical sample 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.
Qualified candidates must have a Bachelor's degree from an accredited college or university; PhD in biological sciences or related field with 5 or more years of industry experience post degree. Candidates must be experienced in oncology drug development.
Must have at least 3 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.
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.
Ability to travel up to 20%
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 Associate Director Clinical Biomarkers
City Basking Ridge
Functional Area Global Oncology R&D
State New Jersey Associated topics: aseptic, biopharma, histologist, immunoassay, immunohematology, nephrology, pharmacology, pharmacometrics, transfection, vaccine
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.