Principal Scientist – Translational Medicine

This is a fully remote position, open to applicants in California, +1 more state.

📋 Description

• Collaborate with discovery and preclinical teams to identify and prioritize translational biomarkers.

• Convert preclinical findings into clinical biomarker strategies, encompassing pharmacodynamics, target engagement, and disease-relevant endpoints.

• Lead the development, qualification, and validation of biomarker assays.

• Supervise assay transfer, validation, and execution at CROs and external laboratories.

• Ensure that assays are executed in CLIA-compliant or equivalent environments when applicable.

• Collaborate with Clinical Operations to design schedules for sample collection, lab manuals, and logistics workflows.

• Coordinate with clinical sites and vendors to guarantee sample integrity and operational feasibility.

• Integrate biomarker data with clinical, PK/PD, and safety datasets to produce decision-ready insights.

• Contribute to the design of clinical protocols, regulatory documentation, and cross-functional decision-making.

• Act as a key partner across discovery, clinical development, clinical operations, regulatory, and data science teams.

• Drive the clinical biomarker strategy and execution throughout early neuroscience clinical programs.

• Transform discovery-stage hypotheses into clinically actionable biomarker strategies for global studies.

⛳️ Requirements

• PhD or equivalent in a relevant field.

• Over 8 years of experience in translational medicine, biomarker sciences, or clinical bioanalysis.

• Proven experience managing biomarker strategies in global clinical studies and collaborating with CROs.

• Strong understanding of biomarker assay platforms and bioanalytical validation principles.

• Experience working in or with CLIA or regulated laboratory settings.

• Background in neurology or CNS disorders is preferred but not mandatory.

• Experience with intrathecal or CNS-targeted therapeutics is preferred.

• Familiarity with CSF biomarker workflows or neurophysiological biomarkers such as EEG is preferred.

• Experience contributing to regulatory submissions is preferred.

• Capability to operate cross-functionally across discovery, clinical development, and clinical operations.

• Expertise in biomarker strategy, assay development, and clinical implementation.

• Experience driving initiatives through CROs and external partners.

🏝️ Benefits

• Patient Days offering opportunities to hear directly from patients.

• A culture inspired by company values.

• A decentralized operating model.

• Ownership of program and career vision.

• A collaborative, fast-paced, data-driven environment.

• Access to learning and development resources.

• A robust and competitive compensation and benefits package.

• Performance bonuses.

• Equity options.

• Health and welfare programs.

• Retirement programs.

• Flexible PTO.

• Rapid career advancement for high performers.

• Opportunities to work on multiple programs across various therapeutic areas.

• Partnerships with leading institutions.