Principal Scientist, Bioanalytical & Biomarker Development

Beacon Hill; Lexington (MA); On-site; USD 150,000 - 210,000; Full time

Job summary

Beacon Hill is partnering with a leading biotech company in Massachusetts to recruit a Principal Scientist, Bioanalytical & Biomarker Development (Contract). The role supports preclinical and clinical programs with a focus on LC-MS-based bioanalysis and biomarker strategy across modalities.

The ideal candidate will drive assay development, data interpretation, and CRO oversight, collaborating with Translational Sciences, Clinical Development, DMPK and Biometrics to inform key program decisions.

Qualifications

• PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, Bioanalytical Sciences, or related field.
• 8+ years of pharma/biotech/CRO experience in bioanalytical method development and biomarker analysis.
• Experience developing, validating, and implementing bioanalytical assays across diverse matrices.
• Strong PK, biomarkers, translational sciences, and clinical development knowledge.
• Proven ability to interpret complex bioanalytical data for development decisions.

Responsibilities

• Serve as the internal SME for LC-MS-based bioanalytical and biomarker development activities.
• Lead development, qualification, and implementation of LC-MS methodologies for PK and biomarker endpoints.
• Interpret complex datasets and communicate findings to project teams.
• Develop innovative biomarker strategies to support translational and clinical objectives.
• Provide technical oversight of assay development and CRO data, ensuring regulatory compliance.
• Collaborate with cross-functional teams and external CROs to design studies and strategies.

Skills

LC-MS expertise

Biomarker development

Data interpretation

Cross-functional collaboration

Scientific communication

Education

PhD in Analytical Chemistry / Biochemistry / Pharmaceutical Sciences

Tools

LC-MS/MS

Job description

Principal Scientist, Bioanalytical & Biomarker Development (Contract)

Department: Preclinical & Clinical Development Sciences

Team: Bioanalytical & Biomarker Development

Reports To: Director, Bioanalytical & Biomarker Development

Duration: 6-12 Months (Potential Extension)

Position Summary

Our client is seeking an experienced Principal Scientist to provide bioanalytical and biomarker development expertise supporting preclinical and clinical development programs. This individual will serve as a subject matter expert in liquid chromatography-mass spectrometry (LC-MS) technologies and will play a critical role in biomarker strategy, assay development, bioanalytical data interpretation, and CRO oversight across multiple therapeutic programs.

The ideal candidate will bring deep experience developing and implementing LC-MS-based bioanalytical and biomarker methodologies within a drug development environment, preferably supporting oligonucleotide, peptide, protein, or other complex therapeutic modalities. This role will partner cross-functionally with Translational Sciences, Clinical Development, DMPK, Biometrics, and external CROs to generate data that informs key program decisions.

Key Responsibilities

• Serve as the internal SME for LC-MS-based bioanalytical and biomarker development activities.
• Lead the development, optimization, qualification, and implementation of LC-MS methodologies supporting pharmacokinetic and biomarker endpoints.
• Support clinical and preclinical development programs through interpretation of complex bioanalytical datasets and communication of findings to project teams.
• Develop innovative biomarker strategies and analytical approaches to support translational and clinical objectives.
• Provide scientific leadership for ongoing biomarker efforts associated with neuromuscular and rare disease programs.
• Review, evaluate, and independently interpret external CRO-generated bioanalytical data.
• Provide technical oversight of assay development, method transfers, validation activities, and sample analysis performed at CRO partners.
• Collaborate with cross-functional stakeholders to design studies and establish bioanalytical strategies aligned with development objectives.
• Support internal capability development and mentor scientists involved in exploratory and development-stage bioanalysis.
• Contribute to regulatory documentation, study reports, and scientific presentations as needed.
• Ensure all activities comply with applicable GCP, GLP, and regulatory expectations.

Required Qualifications

• PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, Bioanalytical Sciences, or related scientific discipline.
• 8+ years of pharmaceutical, biotechnology, or CRO experience supporting bioanalytical method development and biomarker analysis.
• Extensive hands-on expertise with LC-MS/MS and advanced mass spectrometry platforms.
• Demonstrated experience developing, validating, and implementing bioanalytical assays across diverse biological matrices.
• Strong understanding of pharmacokinetics, biomarkers, translational sciences, and clinical development principles.
• Proven experience interpreting complex bioanalytical datasets and translating results into actionable development decisions.
• Experience managing or overseeing external CRO bioanalytical activities.
• Strong written and verbal communication skills with the ability to influence cross-functional teams.

Preferred Qualifications

• Experience supporting oligonucleotide, RNA-based, gene editing, peptide, protein, or other advanced therapeutic platforms.
• Prior experience supporting neuromuscular disease, rare disease, or genetic medicine programs.
• Familiarity with dystrophin or muscle-related biomarker assessments.
• Experience supporting IND-enabling studies and clinical-stage development programs.
• Background in translational medicine and biomarker strategy development.
• Demonstrated leadership within matrixed development organizations.