The Bioanalytical Expert is responsible for providing scientific leadership and operational oversight for bioanalytical activities supporting the development of the company's therapeutic candidates. Reporting to the Vice President, Clinical Pharmacology, this role serves as the subject matter expert for bioanalytical strategies including but not limited to PK, ADA with a focus on ligand binding and mass spectrometry approaches, assay development, validation, sample analysis, and data interpretation across all stages of clinical development.
In a small biotech environment, the Bioanalytical Expert will work closely with Clinical Pharmacology, Biosample Management, Translational Medicine, Clinical Operations, Regulatory Affairs, Biometrics, Program Management, Quality, and external laboratory partners. The position requires a hands-on, collaborative individual capable of managing outsourced bioanalytical activities while ensuring the generation of high-quality data to support key development and regulatory milestones and decisions.
Tasks
Scientific Strategy & Ownership
- Own the end-to-end scientific strategy and lifecycle management of all clinical-grade PK and ADA assays; ensure methods remain fit-for-purpose, clinical stage appropriateness, and inspection-ready.
- Develop and implement bioanalytical strategies supporting clinical development programs from pipeline to late stage readiness (Phase III).
- Provide scientific expertise for pharmacokinetic (PK), immunogenicity, biomarker, and pharmacodynamic (PD) assessments, including guidance on preparing lab manuals and sample collection kits
- Ensure bioanalytical approaches are aligned with clinical and regulatory requirements.
- Contribute to dose selection and clinical development decisions through interpretation of bioanalytical data.
Assay Development and Validation
- Provide oversight of assay development, qualification, transfer, and validation activities.
- Ensure assays are fit-for-purpose and compliant with applicable regulatory guidance.
- Review and approve validation plans including statistical analysis, bioanalytical data reports, method descriptions, amendments and analytical methods.
- Responsible for ensuring relevant bioanalytical documents are provided for CSR and TMF documentation
- Support the implementation of novel analytical technologies and methodologies when appropriate.
CRO Technical Leadership
- Serve as the primary scientific interface with CROs for method development/transfer, validation, updates, oversight, and data quality; drive timely issue resolution.
- Lead the transition of assays from internal research/preclinical lab to clinical readiness.
- Lead RFP process (if required) and select, qualify, and manage CROs and bioanalytical laboratories.
- Monitor vendor performance, timelines, budgets, and deliverables.
- Review contracts, statements of work, and project plans.
Bioanalytical Data Review
- Review and interpret bioanalytical data generated from nonclinical and clinical studies.
- Ensure data quality, integrity, and consistency across programs.
- Collaborate with Clinical Pharmacology and Biometrics teams to integrate bioanalytical findings into PK and PK/PD analyses.
- Identify and proactively address data trends, risks, and potential issues.
Regulatory Support
- Author and review bioanalytical sections of regulatory submissions
- Contribute to IND, CTA, NDA, BLA (particularly M2.7.1.), and MAA documentation.
- Support responses to health authority questions related to bioanalytical methods and data.
- Ensure compliance with FDA, EMA, ICH, and other global regulatory expectations.
Cross-Functional Partnership
- Partner closely with Clinical Development, Clinical Pharmacology, Sample Management, Translational Medicine, Regulatory Affairs, Quality, and Biometrics to align bioanalytical deliverables with program needs and submissions.
- Provide expertise for study design and sampling strategies.
- Support biomarker and companion diagnostic initiatives where applicable.
- Participate in project team meetings and program governance discussions.
Requirements
- PhD, MSc, or equivalent degree in Bioanalytical Sciences, Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline.
- Typically 5-10 years of experience in bioanalysis within biotechnology, pharmaceutical, CRO, or related environments.
- Demonstrated experience supporting clinical development programs.
- Experience with small molecules, biologics, peptides, or other advanced therapeutic modalities.
- Prior experience managing outsourced bioanalytical activities and CRO relationships.
- Experience in a small or virtual biotech organization is highly desirable.
- Strong knowledge of Bioanalytical method development and validation, LC-MS/MS methodologies, Ligand-binding assays (ELISA, MSD, etc.) and cell-based assays (binding, reporter assays).
- Good experience with Immunogenicity testing strategies, Biomarker assay development and validation, Pharmacokinetics and PK sample analysis, Regulatory bioanalytical guidance and industry standardsKnowledge of GxP laboratory requirements.
Benefits
We offer a competitive compensation package and opportunities for career growth and development. If you are a highly motivated and skilled scientist looking to join a dynamic and innovative team, please submit your CV.
Candidate needs to hold a US working permit or be an US citizen
PhD, MSc, or equivalent in a relevant scientific discipline and typically 5–10 years of bioanalysis experience, including clinical development, assay validation, LC-MS/MS, ligand-binding assays, CRO oversight, and regulatory support.
Key Responsibilities
- owning assay strategies
- overseeing CROs
- interpreting data
Skills & Tools
LC-MS/MS, ELISA, MSD, FDA, EMA, ICH, GxP, IND, CTA, NDA, BLA, MAA, PK, ADA, PD, TMF, CSR, RFP
Job Details
- Category: Research and Development (R&D)
- Seniority: Senior Level
- Commitment: Full Time
- Workplace: Remote — Boston, Massachusetts, United States
- Languages: English
About Alentis Therapeutics
A biotechnology company developing therapeutic candidates. — Industry: Research and Development