Overview In this Principal Scientist role, you will lead bioanalytical strategy and execution across discovery and clinical programs, shaping biomarker and PK/ADA methods. You will oversee CROs, ensure data quality, and drive regulatory submissions with cross-functional teams. You'll translate complex biology into fit-for-purpose analytical strategies and mentor teams to deliver high-impact, clinically relevant data. This is a fast-paced, cross-disciplinary role at the forefront of biomarker sciences that impacts translational and regulatory decisions.
Compensation / Benefits- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Paid vacation and year-end shutdown time off
- 401(k) with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement up to $10,000 per year
Responsibilities- Provide scientific leadership on bioanalytical strategies aligned with program goals
- Develop and implement fit-for-purpose bioanalytical approaches (PK, ADA) and biomarker methods (TE, PD, Disease)
- Lead assay development, analytical validation, and sample analysis plans
- Oversee CROs and external labs, including data review and vendor management
- Review validation reports, protocols, and data packages for regulatory compliance
- Investigate assay issues and perform root cause analyses with corrective actions
- Develop and validate assays on various platforms and explore novel biomarker technologies
- Monitor assay performance and data quality across studies to ensure data integrity
- Support IND/CTA/BLA and other regulatory submissions with scientific content
- Contribute to publications, conferences, and best practices in the field
- Support audits and inspections through documentation and study records
Key requirements- PhD with 5+ years of relevant industry experience or MS with 8+ years of relevant industry experience
- Experience developing and implementing biomarker and bioanalytical assays across discovery and clinical development
- Advanced expertise in method development and validation in regulated environments
- Experience supporting sample analysis and data review
- Familiarity with regulatory filings for biomarker and bioanalytical work
- Experience providing scientific oversight of CROs and external labs
- Excellent technical writing, analytical interpretation, and communication skills
- Ability to influence cross-functional teams in a matrixed environment
- Strong verbal and written communication, with tailored presentations for diverse audiences
- Ligand-binding and cell-based assay technologies across multiple platforms
- Industry experience in biomarker sciences, translational research, or bioanalytical sciences
- strong communication
- independence
- cross-functional influence
- biomarker and bioanalytical assay development
- method development and validation
- PK/ADA/TE/PD biomarker assays
