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Senior Principal Scientist, Biomarkers
Remote, VA US
Our client is searching for a Senior Principal Scientist, Biomarkers reporting to the Senior Director, Bioanalytical Methods. This is an opportunity to come in on the ground floor of building a great company focused on a critical unmet medical need, Alzheimer’s Disease.
- Leads the external implementation of program-specific clinical biomarkers to support target engagement, pharmacodynamic measures, safety and efficacy readouts.
- Develops biomarker strategy including assay design, platform choice, selection of standards, controls and acceptance criteria to ensure high sensitivity and specificity of measures that align with required deliverables and timelines to share with Clinical Research Organization (CROs) and other vendor partners. Communicates strategy and timelines to management.
- Acts as key biomarker liaison to the biomarker CROs/and internal/external clinical operations and regulatory teams to help support the development of biomarker kits, laboratory manuals, specimen handling, collection, and storage guidances/ instructions.
- Acts as the key reviewer of Agreements (SOW; SOPs; SAP; DTA) and contributes to the biomarker component of database setup for key inputs to ensure required details for biomarker analysis are captured.
- Oversees selection of vendor for storing clinical samples ensuring clinical feasibility, cost efficiencies and processes that provide critical sample data capture to simplify oversight of downstream sponsor required sample retrieval for shipment/future analysis; ensures the completeness of sample listing inventory.
- Reviews training materials as needed for site initiation meetings.
- Provides critical input in the interpretation of biomarker data.
- Supports end of study biomarker sample reconciliation needs.
- Ph.D. or M.D. and 8+ years of related professional experience in a clinical research setting in a pharmaceutical/biotech R&D environment.
- Strong experience in biomarker assay development particularly immunoassays (Simoa, Lumipulse) and data analysis.
- Strong experience in biomarker analysis in clinical trials focused on dementia.
- Ability to work collaboratively in a team environment with a variety of functional groups (such as clinical operations, quality, regulatory affairs and project management) to support clinical studies.
- Ability to communicate clearly, efficiently and accurately with internal team members and external partners.
- Detailed oriented with ability to work independently and manage multiple tasks focusing on deliverables and timelines.
- Up to 20% of travel may be required.