Associate Director, Bioanalytical Development

Scorpion Therapeutics; Town of Boston (NY); Hybrid; USD 180,000 - 235,000; Full time

Job summary

Scorpion Therapeutics is seeking an Associate Director, Bioanalytical to lead strategy and execution for bioanalytical assays across small molecules and biologics. You will drive assay plans, ensure data quality, and coordinate with Clinical Pharmacology, Data Science, and Regulatory teams.

You will manage CRO/vendor performance, oversee immunogenicity and PK/TK workflows, and help scale the Trial Engine platform, with a focus on GxP compliance and regulatory readiness.

Qualifications

• PhD with 7+ years of bioanalytical experience in clinical-stage biopharma.
• Alternatively, an undergraduate with 10+ years of bioanalytical experience.
• Expertise in LC-MS/MS and biologics bioanalysis.
• Experience managing external CROs/vendors and regulatory expectations for GxP bioanalysis.
• Strong communication skills.

Responsibilities

• Define assay plans and strategies for bioanalytical programs.
• Manage CRO/vendor performance and alignment with project timelines.
• Oversee end-to-end bioanalytical workflows—PK/TK, immunogenicity, and metabolites for data quality and regulatory readiness.
• Collaborate with cross-functional teams on study design, sample logistics, and data interpretation.
• Support scaling of the Trial Engine platform through standardization efforts.

Skills

LC-MS/MS

Biologics bioanalysis

Immunogenicity assay development

Regulatory compliance

Vendor management

Communication skills

Education

PhD with 7+ years

Undergrad with 10+ years

Job description

Role

Associate Director, Bioanalytical, leading strategy and execution for bioanalytical assays supporting biopharma programs involving small molecules and biologics.

Responsibilities

• define assay plans
• manage CRO/vendor performance
• oversee end-to-end bioanalytical workflows—including PK/TK, immunogenicity, and metabolites to ensure data quality, regulatory compliance, and readiness for submissions
• collaborate with cross-functional teams on study design, sample logistics, and data interpretation
• support scaling of the Trial Engine platform through standardization efforts

Requirements

• PhD with 7+ years or relevant undergraduate with 10+ years in bioanalytical support within clinical-stage biopharma
• expertise in LC-MS/MS, biologics bioanalysis, immunogenicity assay development, and validation
• experience managing external vendors and understanding regulatory expectations for GxP bioanalysis
• strong communication skills

Preferred

• experience integrating bioanalysis within clinical teams
• GCP/GCLP familiarity
• sample logistics planning

HighValue

focus on clinical programs involving small molecules and biologics, PK/TK, immunogenicity, IND/CTA and NDA/BLA filings, cross-functional collaboration with Clinical Pharmacology, Data Science, and Regulatory.

WorkSetup

hybrid in NYC or Boston; relocation preferred.