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Associate Director Clinical Biomarkers

Employer
Daiichi Sankyo
Location
Basking Ridge, New Jersey, United States
Start date
May 21, 2019

View more

Discipline
Clinical, Clinical Research
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Pharm Country

Job Details

Posting Title: Associate Director, Clinical Biomarkers

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:

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.

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 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.

Education/Experience:
  • 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

Company

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.

For more information, please visit: www.daiichisankyo.com.

Daiichi Sankyo, Inc., headquartered in Basking Ridge, New Jersey, is a member of the Daiichi Sankyo Group. To learn more about Daiichi Sankyo, Inc., please visit www.dsi.com.

STOCK EXCHANGE: Tokyo Stock Exchange

STOCK SYMBOL: 4568

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Company info
Website
Phone
(908) 992-6400
Location
211 Mt. Airy Road
Basking Ridge
New Jersey
07920
United States

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