About the Role
Lead the design, validation, and execution of biomarker assays to support clinical programs in neuroscience. Coordinate with cross-functional teams to ensure data quality, regulatory compliance, and timely delivery of translational insights.
Responsibilities
- Oversee development and validation of clinical biomarker assays for neuroscience applications
- Ensure assay methodologies meet regulatory and clinical trial requirements
- Collaborate with clinical operations and data management teams on sample tracking and analysis timelines
- Provide scientific expertise during protocol development and study design phases
- Lead troubleshooting and optimization of assay platforms
- Manage external laboratory partners and contract research organizations
- Ensure data integrity and compliance with quality standards across all biomarker workflows
- Develop and maintain standard operating procedures for assay execution
- Support regulatory submissions with biomarker-related data and documentation
- Interpret biomarker results in the context of clinical outcomes
- Communicate findings to internal stakeholders and project teams
- Stay current with advancements in biomarker technologies and neuroscience research
- Contribute to biomarker strategy for early and late-stage clinical programs
- Align assay development with translational science objectives
- Train team members on assay protocols and data analysis methods
- Monitor project timelines and deliverables related to biomarker activities
- Evaluate new technologies for potential integration into biomarker pipelines
- Ensure proper documentation and archiving of assay data
- Participate in cross-functional team meetings and scientific reviews
- Support audit readiness and inspection processes for biomarker labs
- Maintain awareness of competitive landscape in neuroscience biomarkers
- Drive continuous improvement in assay performance and throughput
- Coordinate sample logistics between clinical sites and testing laboratories
- Establish metrics for assessing assay reliability and clinical utility
- Foster collaboration between research, clinical, and analytical departments
Compensation
Competitive salary and benefits package offered
Work Arrangement
Hybrid work model with partial on-site requirements
Team
Part of the Translational Science team focused on neuroscience research and development
Why This Role Matters
This position plays a critical role in linking laboratory science with clinical outcomes in neuroscience. The work directly informs go/no-go decisions in drug development and contributes to advancing novel therapies for patients with neurological conditions.
Growth Opportunity
The role offers the chance to lead biomarker strategy within a growing translational team, with opportunities to shape scientific direction and mentor junior scientists as the organization expands.
Sponsorship available for qualified candidates
