About the role
Principal Scientist, Bioanalytical & Biomarker Development (Contract)
Location: Boston, MA (Hybrid Preferred)
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.
- Experience developing protein biomarkers using LC-MS methodologies.
- 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.
Millions of jobs, with real people getting hired every day
Questions, answered
Click "Apply with JobAssist" – we tailor your resume and application to this role and submit it for your approval.
Yes. This role at Beacon Hill was screened before publishing – we confirmed the employer before listing it.
The employer didn't disclose a salary range for this listing. JobAssist shows pay whenever it's available.
This position can be done from anywhere, with no in-office requirement.
Yes – every application is tailored from your profile and this job's requirements, and you can review and edit before it's sent.