Associate Director, Clinical Sample Management in Bernards, NJ at DSI

Date Posted: 5/31/2018

Job Snapshot

Job Description

About Daiichi Sankyo Cancer Enterprise

The vision 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 Franchise, 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 be in Clinical Development Operations department. This position is responsible for vendor (sample) management, provide input regarding strategy and oversee clinical sample management collected for all Daiichi Sankyo clinical trials. This position will act as a central point of contact between the Biomarker group, clinical teams and CROs to operate a central sample management system.

Works closely with cross-functional study team to implement and operationalize clinical trials. Supports the creation of documentation related to clinical sample acquisition and management in clinical trials. Oversee master/country/site level informed consent languages related to the sample management and handle the clinical samples in accordance with the informed consent language and status. Build and maintain central clinical sample management system in collaboration with specialized vendor(s) to monitor sample tracking and inventory data of all Daiichi Sankyo clinical trials for maintaining compliant operation and data integrity. Support all aspects of sample management during the planning/startup and execution of a clinical trial protocol. Supports biomarker and translational research sample tracking, management and all related requirements. Manages and oversees central laboratory and specialty vendors and ensure smooth laboratory operations and timely transfer of clinical samples and data. Oversees clinical samples inventories, utilization and destruction at a single sample level. Participate with the biomarker/CDx/PGx sub-functions in the evaluation of new capabilities aimed at collecting clinical biomarker samples from clinical trials.

Responsibilities:
  • Collaborates with cross-functional study teams and sub-teams.
  • Supports individual clinical study teams and biomarker sub-teams as required for all technical and operational sample-related matters.
  • Analyzes sample tracking/management-related issues and uses judgment to escalate issues to the appropriate team members.
  • Manages acquisition of clinical trial samples designated for biomarkers, precision medicine and/or exploratory research.
  • Reviews clinical sample-related clinical documents including clinical protocols, ICFs, CRFs and laboratory manuals for successful study start-up.
  • Acts as escalation point to address informed consent and Institutional Review Board/Ethical Committee questions related to clinical sample(s) for clinical trials.
  • Provides guidance to clinical study teams and clinical sites regarding collection and storage of clinical sample acquired in the course of clinical trials.
  • Manages relationships with central laboratory(ies) and specialty vendors including defining contracts and vendor oversight management, with the support of the appropriate study team members.
  • Participate in sample and data reconciliation activities.
  • Manage samples that are transferred to long term sample storage facilities post-clinical study (post-approval of clinical study report).
  • Works within a matrix environment, collaborating with internal and external customers as needed to improve existing processing and identify a need for development of new processes related to sample management.
  • Will be responsible for developing any DSI specific policies, SOPs/SOI or other guidance documents as required.
Required Skills:
  • Working knowledge of ICH/GCP and regulatory guidelines/directives.
  • Working knowledge of CLIA/CAP regulations and GLP guidelines.
  • A strong preference for a candidate having science background and broad technical experience of biological assays.
  • Understanding of bioethics of human bio specimen collection and research.
  • Ability to work independently as well as collaboratively in a matrixed team environment.
  • Excellent written and verbal communication and presentation skills in small and large group settings.
  • Ability to adjust priorities in a fast paced environment.
  • Strong organizational and networking skills.
Education and Experience:
  • Preferably the candidate must possess a B.S., M.S. or Ph.D in biological sciences or related field.
  • Must have at least 8 plus years or more industry experience in clinical sample management.
  • Experience overseeing the clinical sample management at CROs is highly preferred.
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.