POSITION OVERVIEW:

The Associate Director/Director, Bioanalytical will provide technical and operational support for bioanalytical activities supporting DISC Medicine’s drug development programs. This role will independently oversee outsourced bioanalytical studies conducted in GLP/GCP and non-GLP environments and support a broad range of drug modalities.

The successful candidate should have extensive expertise in regulated bioanalysis, demonstrated industry experience supporting both pre-clinical and clinical development, and a strong understanding of regulatory expectations for bioanalytical sciences. This individual will work cross-functionally with discovery, nonclinical, clinical, DMPK, and external CRO partners to ensure high-quality bioanalytical support, including PK, anti-drug antibody (ADA), and biomarker analyses, across different programs.

RESPONSIBILITIES:

• Lead technical and operational bioanalytical activities, including assay development, validation, sample analysis, data review and reporting, regulatory document authoring, and regulatory interactions, supporting drug candidates ranging from small molecules to biologics. This includes bioanalytical assays for PK, biomarkers, and ADA across preclinical and clinical programs.
• Serve as the bioanalytical project lead and strategic partner to internal cross-functional teams to identify and address bioanalytical needs for assigned development programs.
• Collaborate closely with CROs and external laboratories to develop and execute bioanalytical strategies, including method development, validation, sample analysis, troubleshooting, and issue resolution.
• Oversee bioanalytical timelines, data quality, resource planning, and vendor deliverables to ensure alignment with program objectives and regulatory requirements.
• Serve as the Subject Matter Expert (SME) for bioanalytical sciences within DISC Medicine.
• Contribute to regulatory submissions and interactions, including preparation and review of bioanalytical sections of regulatory documents and responses to regulatory inquiries.

 REQUIREMENTS:

• Ph.D. in a relevant scientific discipline with 8+ years of industry experience in bioanalysis. Level will be commensurate with qualifications and experience.
• Hands-on experience supporting GLP toxicology and clinical studies, with strong familiarity with applicable bioanalytical regulatory guidance and industry best practices.
• Demonstrated expertise in bioanalytical assay development and validation, including LC-MS/MS, ligand-binding assays, and cell-based assays, supporting both small molecules and biologics.
• Practical, hands-on experience with cell-based assays, including flow cytometry and cell-based neutralizing antibody (NAb) assays, is preferred.
• Experience with biomarker and/or pharmacodynamic (PD) marker bioanalysis is highly desirable.
• Broad understanding of drug discovery and development, including DMPK/ADME principles and the role of bioanalysis in supporting preclinical and clinical development.
• Proven experience managing CROs and external vendors, including oversight of timelines, quality, budgets, and deliverables, with a willingness to remain hands-on in technical execution and problem solving.
• Excellent interpersonal, communication, collaboration, and problem-solving skills.
• Strong written and verbal communication skills, with the ability to effectively communicate complex scientific concepts to both technical and cross-functional audiences.