Bioanalysis Strategy Lead — CRO Partnerships

Madrigal; Conshohocken (Montgomery County); On-site; USD 273,000 - 315,000; Full time

Benefits offered by this job

Flexible PTO

Insurance: medical/dental/vision/life

401(k) with match

Equity

Mental health benefits

Voluntary benefits

Job summary

Madrigal is seeking a Senior Director, Bioanalysis to lead bioanalytical sciences across clinical and nonclinical programs. You will define strategies, oversee CRO partnerships, and ensure high-quality, regulatory-compliant data for PK/PD evaluations.

This role requires 15+ years in bioanalysis, advanced degree in a related field, and the ability to drive cross-functional, outsourced initiatives in a fast-paced environment. Equity and competitive compensation are offered.

Qualifications

• Advanced degree in analytical chemistry, organic chemistry, pharmaceutical sciences or a related field preferred (Ph.D. or similar)
• 15+ years of bioanalytical experience in clinical and nonclinical development
• Experience leading outsourced CRO bioanalytical activities
• Experience supporting both clinical and nonclinical development programs
• Proven ability to balance rigor, speed, and risk; strong cross-functional communication

Responsibilities

• Define and implement bioanalytical strategies across programs through external partnerships
• Select, manage, and evaluate CRO partners for quality, timelines, and budget
• Develop scalable CRO partnering strategy including transfer and lifecycle management
• Oversee assay development, qualification, validation, and sample analysis by external partners
• Develop bioanalytical strategy for all modalities in preclinical and clinical portfolios
• Ensure all bioanalytical activities meet global regulatory requirements (FDA/EMA/ICH)
• Review and approve bioanalytical documentation and reports
• Lead issue resolution and continuous CRO performance improvements
• Collaborate with Clinical Operations, Regulatory and other R&D functions

Skills

LC-MS/MS

Bioanalytical assay development

Bioanalytical validation

Hybridization-based assays

Ligand binding assays

Immunoassays

Regulatory knowledge

Education

PhD or equivalent

Job description

Madrigal is seeking a Senior Director, Bioanalysis to lead bioanalytical sciences across clinical and nonclinical programs. You will define strategies, oversee CRO partnerships, and ensure high-quality, regulatory-compliant data for PK/PD evaluations.

This role requires 15+ years in bioanalysis, advanced degree in a related field, and the ability to drive cross-functional, outsourced initiatives in a fast-paced environment. Equity and competitive compensation are offered.