Senior Director, Bioanalysis: Strategic CRO & Regulatory Leader

Madrigal Pharmaceuticals, Inc.; Conshohocken (Montgomery County); Hybrid; USD 273,000 - 315,000; Full time

Benefits offered by this job

Equity compensation

Flexible paid time off

Health, dental, vision insurance

401(k) with employer match

Mental health benefits

Job summary

Madrigal Pharmaceuticals, Inc. is seeking a Senior Director, Bioanalysis to provide strategic leadership across bioanalytical sciences for clinical and nonclinical programs. You will define strategies, oversee external partners, and ensure regulatory-compliant data for PK/PD evaluations.

The role emphasizes CRO management, cross-functional collaboration with Clinical Operations, Regulatory, and Translational Medicine, and leadership in regulatory submissions (IND/CTA, NDA/BLA).

Qualifications

• Advanced degree in analytical chemistry, pharmaceutical sciences or related field.
• 15+ years of experience in bioanalytical sciences, with a focus on regulatory-compliant data generation.
• Experience leading CRO-based bioanalytical programs and outsourcing.

Responsibilities

• Define and implement bioanalytical strategies across multiple programs with external partners.
• Select, manage, and evaluate CROs to ensure quality, timelines and budget adherence.
• Develop scalable CRO partnering strategies including assay transfer and validation.
• Oversee assay development, qualification, validation and sample analysis by external partners.
• Lead bioanalytical strategy for regulatory submissions (IND/CTA, NDA/BLA) and regulator engagement.
• Collaborate with Clinical Operations, Regulatory, and Translational Medicine to advance programs.

Skills

LC-MS/MS

Bioanalytical assays

Assay validation

Immunoassays

Education

PhD preferred

Job description

Madrigal Pharmaceuticals, Inc. is seeking a Senior Director, Bioanalysis to provide strategic leadership across bioanalytical sciences for clinical and nonclinical programs. You will define strategies, oversee external partners, and ensure regulatory-compliant data for PK/PD evaluations.

The role emphasizes CRO management, cross-functional collaboration with Clinical Operations, Regulatory, and Translational Medicine, and leadership in regulatory submissions (IND/CTA, NDA/BLA).