Biomarker Scientist, Innovative Medicines

What is Innovative Medicines at Bristol-Myers Squibb?

Innovative Medicines at Bristol-Myers Squibb is a global development and commercial division focused on the Cardiovascular, Fibrosis and Immunoscience therapeutic areas.

We are committed to innovative approaches to help patients prevail against serious diseases.

From research to patient-centric activities, we foster a collaborative culture and invest in meaningful developmental opportunities for our people. We focus on the activities that increase the speed of the development and delivery of our innovative treatments to patients in need of novel therapies.

We are a unique organization where team members are encouraged to have broad roles and to contribute beyond their functional area, all in an effort to accelerate medicines to patients.

We are a fast, adaptable and agile enterprise. Through narrowed focus, nimble decision making, and cross-functional coordination, we are fueling the growth of our marketed medicines and accelerating the delivery of our most promising assets in the pipeline.

The Biomarker Scientist contributes to and is responsible for executing clinical translational strategies for the Innovative Medicines Development (IMD) pipeline. This scientist works on various projects across all stages of drug development and will act as a key interface with the IMD biomarker leads, Translational Sciences Technology functions, and CROs.

Primary Responsibilities:

• Responsible for integrating translational research and clinical development objectives, contributing to data generation strategies, data interpretation and communication to the IMD clinical teams.
• Engages functional groups to help develop, champion, implement and align biomarker strategies for development projects in support of the overall R&D portfolio goals.
• Accountable and responsible for protocol-level operational planning for biomarker activities; this may include support or oversight of study start-up, sample planning and management, and data generation. Specific deliverables may include (but are not limited to) authoring and checking the accuracy of the biomarker portion of protocols, investigator brochures, informed consent, statistical analysis plans, lab sample requirements / lab manuals, data management and transfer plans, interim analyses, and clinical study reports.
• Ensures timeliness of data delivery; Leads efforts to curate and integrate datasets (biomarker results, sample characteristics, clinical outcome) to facilitate exploratory analyses.
• Facilitates external engagement with vendors and CROs to ensure success for any outsourced elements of the strategy.

Additional Responsibilities:

• Ensures the output of the biomarker plans meets established project standards.
• Engages team members to ensure alignment of biomarker strategies with clinical operational plans with functional area capabilities.
• Builds productive relationships with team members that interact with the clinical biomarker group.
• Cooperates with functions to maximize resources for optimal portfolio prosecution.
• Effectively interfaces with functional areas to ensure strategic alignment and to obtain appropriate operational resources to deliver on biomarker goals.
• Communicates key biomarker program information, risks, and milestones, and manages information flow across team members.
• Responsible for understanding external research environment, partnering with discovery biology and other functions both internally and externally to coordinate the execution of Translational IMD R&D deliverables.
• Continually analyzes progress, engages in critical thinking, and asserts strong problem-solving towards delivering key data and interpretation essential for decision making.
• Supports IMD Biomarker Leads in the development of program-level biomarker execution strategies, including literature searches and/or ad hoc data analyses as requested.

Qualifications:

• M.A, PhD, or equivalent advanced biology degree.
• Experienced scientist with 5+ years of experience (M.A.) or 3+ years of experience (Ph.D) in the drug development process.
• Significant understanding of the role of translational research/medicine and clinical biomarkers in drug development.
• Demonstrated commitment to operational excellence. Careful, accurate, detailed execution of the work is essential.
• Demonstrated ability to work in a matrix environment and multitask across multiple development assets in a fast-paced environment.
• Demonstrated flexibility to support the unique needs of each project and team.
• Knowledge of Cardiovascular, Fibrosis, or Immunosciences.
• Demonstrated data analysis skills; experience with bioinformatics software tools a plus.
• Significant understanding of all functional areas of drug development, including, biology, toxicology, clinical development, data management and diagnostic development strongly preferred.