Biomarker Operations Lead
Title: Biomarker Operations Lead Location: Central NJ (TBD) Primary Responsibilities • 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. • 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. • 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. • Interface with internal and external partners concerning sample and data-related aspects of exploratory biomarker testing. • Drive biomarker analysis and activities, including but not limited to, facilitating data transfer specification creation in collaboration technical leads and coordination with internal and external partners to support biomarker sample movement; aiding in the selection of appropriate samples, identification of issues/risks associated with project efforts etc. • Support systems development for Translational Medicine capabilities that require integration with biomarker specimen annotations and results. • Identify and implement solutions for study results management issues and concerns, including proactive prevention strategies based on metrics and forecasts • 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) • Manage issue escalations regarding collection or analysis challenges with a particular emphasis on issues such as ensuring sample-related parameters are consistent between lab and BMS, monitoring data turn-around time. • Communicate effectively with central labs, external vendors and BMS labs engaged in sample analysis to ensure consistent execution of biomarker processing, analysis and data delivery. • Engage in specialty projects to drive BMS success of biomarker activities. • Apply learning across capabilities and partners for specific business issues and responds proactively to potential issues to avoid future conflict. • Demonstrate strong communication, interpersonal and negotiating skills and leverages those competencies to ensure continuous progress internal and external teams thus moving issues to resolution. • Negotiate an enterprise (vs. functional) perspective across BMS allowing competing trade-off across the business to be managed. • Partner with TM P&E Leads, Sample Operations Leads, and TM Technology Project Managers to ensure translation of biomarker solutions within TM and broader scientific partnerships. • Serve as TMES liaison to other strategic and process improvement initiatives as required. • Foster teamwork between BMS 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. • Display strong written and oral communication skills. Work with all levels of staff and management to resolve issues and update on progress with tact and diplomacy. Able to work with large and small teams to achieve business goals with a high degree of professionalism and poise. 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.