Senior Scientist, Clinical Research

Role

Summary:

The Senior Scientist, Biomarker Operations Project Management is responsible for planning and executing clinical-trial biomarkers across the pipeline, ensuring compliant, efficient biospecimen collection, assay execution, and data delivery. This role drives operational excellence, data quality, and compliance across the biomarker assay project lifecycle. The Senior Scientist partners closely with scientific and operational colleagues to support a cohesive and agile team that delivers high-quality biomarker data for clinical trials and translational research.

The primary focus is Immunology and Oncology; however, support of additional disease areas may be required as therapeutic focus evolves.

Job Description :

Role

Summary:

The Senior Scientist, Biomarker Operations Project Management is responsible for planning and executing clinical-trial biomarkers across the pipeline, ensuring compliant, efficient biospecimen collection, assay execution, and data delivery. This role drives operational excellence, data quality, and compliance across the biomarker assay project lifecycle. The Senior Scientist partners closely with scientific and operational colleagues to support a cohesive and agile team that delivers high-quality biomarker data for clinical trials and translational research.

The primary focus is Immunology and Oncology; however, support of additional disease areas may be required as therapeutic focus evolves.
Primary Activities Include, But Are Not Limited To:
Collaborate closely with biomarker scientists and study teams to plan clinical-trial biomarker set-up and logistics, enabling efficient study execution.
Serve as the operational partner to Biomarker Leads, helping implement strategies that advance biomarker programs.
Co-author biomarker-related sections of clinical study protocols.
Collaborate with Translational Molecular Biomarker Scientists to define and manage specimen collection, handling, shipping, storage, and processing requirements aligned to the biomarker plan and clinical study protocol.
Develop biomarker vendor statements of work and data-transfer specifications in partnership with clinical teams. Work with clinical teams to coordinate sample and assay logistics, issue resolution and risk mitigation.
Partner with Data Management to transfer biomarker data from external vendors into the clinical data repository.
Work with clinical teams and central laboratories to design sample collection kits, laboratory manuals, and specimen logistics for shipments to third-party vendors.
Build and maintain effective partnerships with external biomarker vendors and internal teams.
Proactively identify and resolve conflicting stakeholders needs to maintain alignment and momentum.
Implement and continuously improve streamlined workflows that maximize efficiency and data quality and reinforce a culture of operational excellence.
Education:
Bachelor’s (with 5 or more years), master’s or higher (with 3 or more years) in a scientific or technological field of study and relevant experience
Experience And Skills:
Project management experience.
Experience in drug discovery and/or clinical research.
Ability to excel in fast-paced, evolving conditions and advocate for operational excellence.
Excellent written and verbal communication skills, with the ability to work within a highly collaborative, matrixed environment.
Required Skills:
Biobank, Biomarker Development, Biomarker Discovery, Biomarker Qualification, Biomarkers, Clinical Research, Drug Research, ICH GCP Guidelines, Protocol Development, Sample Handling
US And Puerto Rico Residents Only:
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