Senior Bioanalytical Scientist: PK, ADA & Assays

Alentis Therapeutics; Boston (MA); On-site; USD 150,000 - 210,000; Full time

Benefits offered by this job

Competitive compensation

Career growth opportunities

Job summary

Alentis Therapeutics is seeking a Bioanalytical Expert to provide scientific leadership and oversee bioanalytical activities supporting the development of clinical candidates.

You will lead PK/ADA strategies, oversee assay development and validation, manage CROs, ensure regulatory readiness, and integrate findings into PK/PD analyses. This role requires hands-on collaboration across Clinical Pharmacology, Regulatory Affairs, and Biometrics to drive high-quality data for milestones.

Qualifications

• PhD or equivalent in bioanalytical disciplines with clinical development exposure.
• Experience supporting clinical programs in biotech/pharma/CRO settings.
• Expertise in PK, ADA, ligand-binding, and MS-based assays.

Responsibilities

• Own the end-to-end bioanalytical strategy for PK/ADA assays across clinical stages.
• Lead assay development, transfer, and validation ensuring fit-for-purpose methods.
• Serve as CRO interface for transfer, validation, and data quality.
• Review CSR/TMF documents and support regulatory submissions with bioanalytical sections.
• Collaborate with Clinical Pharmacology, Biometrics, and QA to align deliverables.

Skills

Bioanalytical strategy

LC-MS/MS

Ligand-binding assays

Immunogenicity testing

PK/PD analysis

CRO management

Regulatory documentation

Education

PhD in Bioanalytical Sciences

MSc in Analytical Chemistry

Job description

Alentis Therapeutics is seeking a Bioanalytical Expert to provide scientific leadership and oversee bioanalytical activities supporting the development of clinical candidates.

You will lead PK/ADA strategies, oversee assay development and validation, manage CROs, ensure regulatory readiness, and integrate findings into PK/PD analyses. This role requires hands-on collaboration across Clinical Pharmacology, Regulatory Affairs, and Biometrics to drive high-quality data for milestones.