Beeline Medicines
Biotechnology
SeniorDirector,Bioanalysis
“Senior Director, Bioanalysis at Beeline Medicines. Skills: Bioanalysis, Drug development, PK/TK analysis, Immunogenicity assays. Lead bioanalytical strategy. Oversee assay development”
What You'll Achieve.
Support program decisions; Support regulatory submissions
Industry & Context.
Root cause analysis; Troubleshooting OOS results
What They're Looking For.
Must Have
Ph. D. in Bioanalytical Chemistry, Pharmacokinetics, Biochemistry, Pharmaceutical Sciences, or related discipline, MS with significant relevant industry experience, 12+ years of relevant experience in bioanalysis, Experience with LC-MS/MS assays for small molecules, Experience with ligand-binding and/or hybrid assays for biologics, Experience with Immunogenicity assays, including ADA and neutralizing antibody methods, Experience interpreting PK/TK data, Experience applying bioanalytical results to development questions, Experience overseeing bioanalytical work across multiple programs, Experience with regulatory expectations for bioanalytical method validation, Experience with sample analysis and reporting, Experience in cross-functional collaboration, Ability to set strategic direction for clinical pharmacology operations, Accountability for quality, compliance, and delivery
Nice to Have
Familiarity of DMPK, Familiarity of PK interpretation
What You'll Do.
Lead bioanalytical strategy
Oversee assay development
Oversee assay qualification
Oversee assay validation
Oversee assay transfer
Oversee assay lifecycle management
Provide scientific oversight for bioanalytical activities
Select external bioanalytical partners
Manage external bioanalytical partners
Ensure high-quality execution
Ensure timely execution
Support investigations for OOS results
Support root cause analyses for deviations
Support root cause analyses for process failures
Review validation reports
Approve validation reports
Review sample analysis plans
Approve sample analysis plans
Approve data packages
Review final study reports
Approve final study reports
Partner closely with Clinical Pharmacology
Partner closely with translational sciences
Support PK/TK interpretation
Support sampling strategy
Contribute to study design
Contribute to study execution
Author bioanalytical contributions to submissions
Review bioanalytical contributions to submissions
Support responses to health authorities
Ensure bioanalytical activities compliance
Perform other duties as assigned
How You'll Work.
Team & Collaboration
Clinical Pharmacology; Translational Sciences; Clinical Development; Regulatory Affairs; Translational Medicine
Communication Scope
Communicate findings clearly
Process & Methodology
Program oversight, Study design, Study execution
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