Associate Director, Bioanalytical

The role

The Associate Director, Bioanalytical will provide technical and operational support for bioanalytical activities supporting drug development programs. This role involves overseeing outsourced bioanalytical studies in GLP/GCP and non-GLP environments for various drug modalities.

What you will do

• Lead technical and operational bioanalytical activities including assay development, validation, sample analysis, data review, and reporting.
• Author regulatory documents and support regulatory interactions.
• Serve as the bioanalytical project lead and strategic partner to internal cross-functional teams.
• Collaborate with CROs and external laboratories to execute bioanalytical strategies.
• Oversee bioanalytical timelines, data quality, resource planning, and vendor deliverables.
• Serve as the Subject Matter Expert (SME) for bioanalytical sciences.
• Contribute to regulatory submissions and responses to regulatory inquiries.

Required qualifications

• Ph.D. in a relevant scientific discipline
• 8+ years of industry experience in bioanalysis
• Hands-on experience supporting GLP toxicology and clinical studies
• Familiarity with applicable bioanalytical regulatory guidance and industry best practices
• Expertise in bioanalytical assay development and validation including LC-MS/MS, ligand-binding assays, and cell-based assays
• Broad understanding of drug discovery and development including DMPK/ADME principles
• Proven experience managing CROs and external vendors
• Excellent interpersonal, communication, collaboration, and problem-solving skills
• Strong written and verbal communication skills

Nice to have

• Practical, hands-on experience with cell-based assays, including flow cytometry and cell-based neutralizing antibody (NAb) assays
• Experience with biomarker and/or pharmacodynamic (PD) marker bioanalysis

Benefits

• Comprehensive benefits
• Competitive compensation packages

About the company

Disc Medicine is a clinical-stage biopharmaceutical company committed to discovering, developing, and commercializing novel treatments for patients who suffer from serious hematologic diseases. The company aims to address hematologic diseases by targeting fundamental biological pathways of red blood cell biology.