Responsible for developing and documenting the Biomarker Testing Plan (BTP) for 15-25 I-O protocols, ensuring implementation of the BTP, and driving time lines for generation and return of data.
Engage internally with medical, clinical, technical and operational leaders to ensure alignment and feasibility and externally with central labs and analyzing labs to ensure success for any outsourced elements of the biomarker strategy.
Collaborate closely with biomarker scientists to document the program/protocol BTP plan and provide guidance for operationalization.
Drive assets within 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.
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).
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).
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.
Bachelor’s degree and 7+ years’ experience in clinical drug development/clinical trial execution, OR
Master’s degree and 2 +years’ experience
Minimum 5-6 years of experience
Clinical sample management is required.
Demonstrates in-depth knowledge of biomarkers, Pharmacokinetics or immunogenicity sample activities, including collections and logistics considerations. Thorough understanding of clinical data management required.
Experience managing multiple projects of significant complexity/global scope, in a highly virtualized team environment.
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).
Strong communication, interpersonal and negotiating skills--leveraging those competencies to ensure continuous progress internal and external teams thus moving issues to resolution.
Highly effective organizational and time management skills.
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.