Bristol-Myers Squibb Company

Biomarker Operations Lead

Princeton, NJ, US
Oct 01, 2018
Required Education
Bachelors Degree
Position Type
Full time
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Primary Responsibilities
  • Collaborate closely with biomarker scientists to develop and document the program/protocol Lab Testing Plan (LTP) and provide guidance for operationalization.
  • Drive the Strategic Sample Planning and Optimization process (S2PO) for assets within his/her Book of Work, ensuring that all required testing is well-defined and documented within supporting systems to facilitate the effective application of Biomarker strategy to our development portfolio. Facilitate necessary conversations with medical, technical and operational leaders to ensure alignment and feasibility. Facilitate external engagement to ensure success for any outsourced elements of the strategy. Interacts with key scientific and operational leaders in single or multiple therapeutic areas.
  • Develop and manage project plans for data delivery to ensure timeliness of data for exploratory analyses and clinical results; from specimen selection, routing, testing, return of data, and analysis of results.
  • Initiate contracting for biomarker work, ensuring alignment between internal technology leads and vendors, review SOW, identify and request samples shipments.
  • Ensure that sample collections, movement, analysis and data sharing are in accordance with protocol and informed consent.
  • Track, resolve and appropriately escalate issues related to sample and/or data quality (overseeing consistency, integrity, and completeness of biomarker data generation following review of results).
  • Support efforts to curate and integrate datasets (biomarker results, sample characteristics, clinical outcome) to facilitate exploratory analysis, e.g. via Spot Fire or other data visualization.
  • Engage effectively with central labs, external vendors and internal labs to ensure timely and consistent execution of biomarker processing, analysis and data delivery.
  • Manage results provided by third-party vendors (e.g., defines data handling conventions, edit checks, quality acceptance; reconciles external data against the clinical data; resolves data discrepancies between the external data and the clinical data).
  • Identify and implement solutions for study results management issues and concerns, including proactive prevention strategies based on metrics and forecasts.
  • Foster teamwork between functional areas; creating a team environment based on mutual trust and respect. Encourage teams to share knowledge, experiences, best practices, and information on an ongoing basis.

Experiences Desired
  • Bachelor's degree and 7+ years' experience in clinical drug development/clinical trial execution, OR Master's degree and 2 +years' experience.
  • Exposure to biomarkers, Pharmacokinetics or immunogenicity sample activities required, including collections and logistics considerations. Thorough understanding of clinical data management required.
  • Firsthand knowledge of laboratory operations highly desired.
  • Demonstrated experience managing multiple projects of significant complexity/global scope, in a highly virtualized team environment.
  • Demonstrated ability to analyze and interpret complex problems/data from a variety of sources, and through effective decision-making and planning, deliver superior business results.
  • Experience in leading organizational/cultural change and managing expectations and risks.

Knowledge Desired
  • Thorough understanding of organizational structure, operating culture, effective work styles and achieving results in a changing environment.
  • Ability to influence in the matrix and across organizational/company boundaries.
  • Experience with bioinformatics and analytical software tools a plus (i.e. JMP, Spotfire).
  • Experience and high degree of fluency with MS Office tools (esp. MS Excel and MS Project).
  • Highly effective organizational and time management skills.