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Associate Director, Bioanalytical Sciences
Kailera Therapeutics. Lead bioanalytical strategy and execution in clinical and non-clinical studies .
Posted 10/26/2026full-timeWaltham • Massachusetts • United StatesSenior💰 $159,000 - $195,000 per yearWebsite
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in bioanalytical strategy and execution, with a strong focus on GLP compliance and regulatory submissions. Proven ability to manage CRO relationships and oversee bioanalytical assay development and validation in clinical and non-clinical studies.
Highest-signal resume keywords
Bioanalytical Strategy LeadershipLC/MS/MS Assay DevelopmentGLP/GCP ComplianceRegulatory Submission ExpertiseProject Management Skills
ATS Keywords
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Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Bioanalytical Assay DevelopmentMethod ValidationRegulatory ComplianceCRO ManagementClinical Development ProgramsData Review and AnalysisBioanalytical ChemistryPharmacologyBiologics Regulatory FilingsIncretin-Based Therapies
Soft Skills
CollaborationLeadershipEffective CommunicationProblem-SolvingPrioritization
Industry Keywords
Bioanalytical SciencesClinical TrialsNon-Clinical StudiesSmall MoleculesPeptidesBiomarkersRegulatory InteractionsVendor RelationshipsIndustry Best PracticesGLP-1 Receptor Agonists
About the role
Key responsibilities & impact- Lead bioanalytical strategy and execution in clinical and non-clinical studies
- Collaborate with cross-functional teams to design and implement bioanalytical aspects of clinical development programs
- Identify, select, and oversee CROs, ensuring adherence to timelines, budgets, and regulatory requirements
- Manage and oversee outsourced bioanalysis of small molecules, peptides, and biomarkers
- Direct the development, validation, and implementation of bioanalytical assays
- Review validation protocols, test procedures, raw data, and technical reports for scientific rigor and regulatory compliance
- Provide leadership in ensuring GLP compliance for bioanalysis in non-clinical and clinical trials
- Author and review bioanalytical sections of regulatory submissions
- Represent the bioanalytical function in cross-functional project teams
- Report to the Director, Bioanalytical Sciences
Requirements
What you’ll need- 10+ years of relevant industry experience in bioanalytical sciences with a Bachelor’s degree, or 5+ years with an advanced degree
- 5 years of hands-on experience in MD/MV of LC/MS/MS assays
- Expertise in regulated bioanalysis and clinical-stage drug development
- In-depth knowledge of GLP/GCP requirements and industry best practices in bioanalytical laboratories
- Proven experience in regulatory requirements for method development and validation
- Strong track record of managing CRO-outsourced bioanalysis and vendor relationships
- Excellent project management skills with the ability to manage multiple priorities effectively
- Experience contributing to regulatory filings for biologics and small molecules
- Bachelor’s degree in a relevant scientific discipline required, such as bioanalytical chemistry, pharmacology, or a related field
- Experience with regulatory interactions is highly desirable
- PhD preferred
- Experience with GLP-1 receptor agonists or related therapeutic areas
- Strong understanding of bioanalytical considerations for incretin-based therapies
Benefits
Comp & perks- Comprehensive health coverage
- Flexible time off
- Paid holidays
- Year-end shutdown
- Monthly wellness stipend
- Generous 401(k) match
- Tuition reimbursement
- Commuter benefits
- Disability insurance
- Life insurance
- Annual bonus opportunities
- Equity grants