Principal Scientist, Biomarker Bioanalytical Sciences
About The Position
The Biomarkers and Systems Biology group is seeking a highly motivated Principal Scientist to contribute to the development and implementation of biomarker and bioanalytical strategies supporting discovery, translational, and clinical-stage programs. The successful candidate will serve as a Bioanalytical Lead for assigned programs, providing scientific leadership for assay development, analytical validation, CRO oversight for sample analysis and data interpretation to support critical development decisions. This role will partner closely with various internal and external functions to ensure the generation and interpretation of high-quality bioanalytical and biomarker data supporting clinical development and regulatory submissions. The ideal candidate brings expertise in biomarker and protein-based assay development, experience managing external bioanalytical activities, strong scientific leadership, and the ability to translate biological questions into fit-for-purpose analytical strategies.
Requirements
- PhD or MS in Immunology, Cellular and Molecular Biology, or a related scientific field.
- PhD with 5+ years of relevant industry experience
- MS with 8+ years of relevant industry experience
- Experience developing and implementing biomarker and bioanalytical assays across discovery and clinical development settings.
- Advanced technical expertise in method development and validation in a regulated environment
- Experience supporting sample analysis and data review.
- Familiarity with biomarker and bioanalytical requirements supporting regulatory filings and clinical development programs.
- Experience contributing bioanalytical content to IND, CTA, BLA, and other regulatory submissions.
- Experience providing scientific oversight of CROs and external laboratory partners.
- Excellent technical writing, analytical interpretation, and communication skills.
- Ability to work independently and effectively influence cross‑functional teams in a matrixed environment.
- Strong verbal and written communication skills with the ability to tailor presentations to diverse audiences.
- Highly flexible, results‑oriented, and comfortable operating in a fast‑paced, dynamic environment.
- Proficiency with ligand‑binding and cell‑based assay technologies across multiple platforms.
- Industry experience in biomarker sciences, translational research, or bioanalytical sciences supporting drug development programs.
Nice To Haves
- Experience supporting clinical biomarker programs.
- Strong publication and scientific communication record.
- Experience authoring and defending bioanalytical content for IND, CTA, BLA, MAA, and other global regulatory submissions.
Responsibilities
- Serve as the bioanalytical representative on assigned discovery and development programs, providing scientific expertise and contributing to biomarker and bioanalytical strategies aligned with program objectives.
- Develop and execute fit-for-purpose bioanalytical approaches (PK, ADA) and support the implementation of Biomarker methods (TE, PD, Disease) supporting the biomarker strategy.
- Lead the design and execution of assay development, analytical validation, and sample analysis plans that support program and regulatory needs.
- Provide scientific oversight of CROs and external laboratories, including assay development, validation, sample analysis, troubleshooting, data review, and vendor management.
- Review protocols, validation reports, sample analysis reports, and bioanalytical data packages to ensure scientific quality, regulatory compliance, and fitness-for-purpose.
- Support investigation of assay-related issues, deviations, and root cause analyses, providing scientific recommendations for corrective actions.
- Develop, optimize, transfer, and validate bioanalytical and biomarker assays on various platforms on existing and emerging analytical platforms.
- Evaluate and implement novel biomarker technologies, assessing platform performance and suitability based on context of use.
- Monitor assay performance, data quality, QC trends, robustness, and cross-study comparability throughout the assay lifecycle, ensuring data integrity and scientific rigor.
- Interpret bioanalytical data and communicate findings, risks, and recommendations to project teams and functional stakeholders.
- Contribute scientific content and data packages supporting IND, CTA, BLA, and other regulatory submissions.
- Support audits and inspections through preparation and review of bioanalytical documentation and study records.
- Contribute to scientific publications, conference presentations, and the advancement of best practices in biomarker sciences, bioanalysis, and CRO management.
Benefits
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
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What This Job Offers
Job Type
Full-time
Career Level
Principal
