Sr. Scientist, Biomarker Operations
About The Position
This role independently executes assigned operational activities to support translational medicine activities during early-phase clinical studies. Responsibilities include coordinating vendors and CROs, tracking contracts and budgets, and utilizing project management tools to ensure accurate, high-quality, and timely data delivery with focus on vendors supporting translational biomarkers or other translational activities. Supports vendor selection and contributes to fit-for-purpose method development and validation, ensuring alignment with study objectives and established translational strategies. Partners closely with Clinical Operations, Clinical Pharmacology and external collaborators to integrate biomarker plans into clinical protocols and oversee sample testing activities in accordance with study timelines and GxP requirements.
Requirements
- BS/BAMS in Biology, Chemistry, or related scientific field AND 4+ years of relevant industry experience OR MSMS in Biology, Chemistry, or related scientific field AND 2+ years of relevant industry experience OR PhD in Biology, Chemistry, or related scientific field AND some relevant industry experience
- Strong rigor and attention to detail
- Consistent ability to meet multiple deadlines, with a high degree of accuracy and efficiency
- Advanced execution mindset with ability to anticipate and manage risks
- Collaborative, team-oriented approach
- Ability to translate scientific and operational requirements into actionable plans
- Ability to manage multiple priorities and collaborate effectively across functions
- Excellent written and verbal communication skills
- Strong experience supporting first-in-human or early-phase clinical studies
- Strong experience working with CROs and external laboratories supporting clinical studies
- Advanced organizational and project management skills; experience with Smartsheet preferred
- Experience with clinical workflows and early clinical development
- Strong knowledge of GxP requirements
- Experience working with CROs to support clinical assay development and sample testing
Responsibilities
- Independently execute and support translational and medicine activities for FIH and early-phase studies within established study strategies
- Plan, manage, and coordinate assigned clinical assay and specimen-related activities in collaboration with internal stakeholders and external vendors
- Manage CROs and assay laboratories in the execution of fit-for-purpose assay development and validation activities
- Track and manage operational deliverables, timelines, and risks for assigned studies using Smartsheet, Excel, and other project management tools
- Contribute to the integration of biomarker and specimen plans into clinical protocols and study execution documents
- Monitor vendor performance for assigned studies and escalate operational risks or quality concerns to senior team members as appropriate
- Collaborate cross-functionally with Clinical Operations, Clinical Pharmacology, Regulatory, Quality Assurance, Data Management, and Outsourcing to support study-level objectives
- Execute clinical specimen collection, testing, and data delivery activities to ensure alignment with study timelines and objectives
- Maintain accurate and complete documentation to ensure GxP compliance and adherence to internal SOPs and regulatory requirements
- Prepare and plan inspection readiness activities by organizing and maintaining study-related documentation
- Prepare summaries and status updates for scientific leadership regarding biomarker and operational progress
- Provide technical expertise and contribute to continuous improvement of operational processes
- Other duties as assigned
Benefits
- retirement savings plan (with company match)
- paid vacation, holiday and personal days
- paid caregiver/parental and medical leave
- health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
501-1,000 employees
