Research Associate II / Senior Research Associate Scientist, Chemistry
MANAGER, TRANSLATIONAL MEDICINE OPERATIONS

BRIS.207

The Manager, Translational Medicine Operations is responsible for providing strategic, tactical, and technology transfer project support for the biomarker programs within UNITY’s drug development programs. The role will directly support the VP, Translational Medicine and Science and operate collaboratively with the research and development leads to achieve the translational research goals of the clinical development plan.  The role is pivotal in ensuring that the biomarker programs are conducted in accordance with best practices, applicable rules and regulations, company policies, standard operating procedures, plans and developed guidelines, as well as ethical standards for medical research.  The role may include, but not be limited to, the following activities:

  • Provide leadership, guidance, and expertise on biomarker operations and sample management (including imaging, fluid, and tissue)
  • Manage/lead the collection of biomarker samples at clinical sites from clinical trials or collaborative research agreements, tracking their distribution, reconciliation, analysis, storage and disposition/destruction. Be accountable for chain of custody for clinical biomarker specimens: collection, management, and traceability; in collaboration with stakeholders in research and development
  • Manage/lead biomarker operations activities ensuring that clinical trial documents including protocols and informed consent forms are aligned with the biomarker plan. Create biomarker sample training materials for clinical sites including lab manuals and reference guides to ensure the collection of high quality samples
  • Manage/lead the vendor selection and qualification process. Facilitates the establishment of master service agreements and scopes of work for biomarker vendors. Tracks activity, budget and informs of any slippage. Produces forecasts and capacity projections for bioanalytical work
  • Provide functional project management for the biomarker sub-team: develop timelines, strategic plans, and budgets
  • Identify, recommend, and implement best practices for biomarker sample management

REQUIREMENTS:

Qualifications and Experience:

  • Bachelor’s or Master’s degree (BS/BA/BScN or higher) in a scientific field: life sciences or Medical/Healthcare related
  • 5+ years biopharmaceutical experience in clinical trials and biomarker operations
  • In depth understanding of biomarker sample operations, best practices, and standardization to ensure high quality sample collection. Understanding of ICH GCP aspects of biospecimen collection, use and storage in an industry setting
  • Knowledge of sample processing and bioanalytical techniques. Understanding of GCLP and the conduct of clinical trial assays
  • Demonstrated ability to manage multiple projects and priorities and complex sample logistics in multiple clinical studies. Experience working with sample repository, vendor, and clinical databases to track, manage and reconcile
  • 3+ years of experience in vendor management and outsourcing. Working knowledge of interacting with central laboratories
  • Knowledge of quality management and the quality cycle as it pertains to chain of custody and data integrity. Understanding of document management best practices
  • Sound computer skills: proficient in the use of Excel and Word and experienced in the use of relational databases and systems for tracking of biological specimens.
  • Ability to work with a high degree of initiative and independence while exercising appropriate judgement when direction is required

 

Skills:

  • Strong organizational, communication (oral and written English), and interpersonal skills
  • Ability to be agile in a fluid start up biotechnology environment

Please send resume and cover letter