Director QCP Clinical Biomarkers in Bernards, NJ at DSI

Date Posted: 2/5/2018

Job Snapshot

Job Description

Join a Legacy of Innovation 110 Years and Counting!

Daiichi Sankyo, Inc. is the U.S. subsidiary of Daiichi Sankyo, Co., Ltd. The Company currently markets therapies in hypertension, dyslipidemia, diabetes, acute coronary syndrome, thrombotic disorders, stroke risk reduction, opioid-induced constipation, IV iron therapy and metastatic melanoma.

Job Summary

This position is within Bioanalytical, Biomarkers and Companion Diagnostics group that resides in the department of Quantitative Clinical Pharmacology and Translational Sciences. The primary responsibilities of this position are to act as a central point of contact between the Biomarker Analysis group, the clinical development teams and CROs. Will direct the outsourcing of clinical biomarker assay development and validation. Will provide biomarker and specialized diagnostic testing support for global clinical trials in all phases of development. This position requires a significant understanding of the biomarker discovery through CDx development process.

Responsibilities

1. Identify appropriate vendors and participate in vendor evaluation/selection for biomarker and CDx assay development, validation and sample analysis across diverse technology platforms. Develop and implement fit-for-purpose clinical biomarker assays at external CROs to support biomarker driven global clinical trials. Evaluate, interpret and present complex scientific data.
2. Provides technical expertise to project teams and CDx development teams on appropriateness of assay methodologies and assay troubleshooting
3. Provide input on biomarker related sections of clinical study protocols including the necessary sample collection, processing and shipping requirements. Collaborates with Clinical Operations to ensure appropriate informed consent language for biomarker-related sample collection and evaluation.
4. Collaborate with functional groups in the US and Japan to develop and implement clinical biomarker strategies supporting all therapeutic areas and stages of drug development.

Qualifications

Education and Experience
  • PhD in biological sciences or related field with 8 or more years of related experience post degree. Candidates experienced in oncology drug development highly preferred.
  • Must have at least 5 years industry experience in fit-for-purpose clinical 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.
  • Must have experience working in a GLP, GLP-like or CLIA environment.
  • A strong preference for a candidate with broad technical. Candidates with flow cytometry and molecular pathology (IHC, ISH) flow cytometry a plus.
  • 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. 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.