Senior Director, Bioanalysis Leadership & CRO Strategy

Madrigal Pharmaceuticals Inc.

Conshohocken (Montgomery County)

On-site

USD 241,000 - 295,000

Full time

5 days ago
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Benefits offered by this job

Equity
Comprehensive benefits
401(k) employer match
Employee Assistance Program (EAP)

Job summary

Madrigal Pharmaceuticals Inc. is seeking a Senior Director of Bioanalytical Sciences to define and lead bioanalytical strategies across multiple programs.

You will partner with CROs to ensure high-quality data, oversee assay development and validation, and support regulatory submissions with robust scientific rationale. The role requires extensive experience in LC-MS/MS and immunoassay methods, with a track record of global regulatory compliance and cross-functional leadership in a fast-paced

Qualifications

  • Ph.D. or advanced degree in analytical chemistry, pharmaceutical sciences or related field preferred.
  • 15+ years of experience in bioanalytical sciences for clinical and nonclinical programs.
  • Proven success leading bioanalytical activities in outsourced/CRO-based models.
  • Strong scientific judgment with ability to influence cross-functional stakeholders.

Responsibilities

  • Define and implement bioanalytical strategies across programs with external partnerships to support clinical and nonclinical development.
  • Select, manage, and evaluate CRO partners for quality, timelines and budget.
  • Develop scalable CRO partnering strategy including assay transfer and lifecycle management.
  • Oversee assay development, qualification, validation, and sample analysis by external partners.
  • Lead regulatory submissions and regulator engagement for IND/CTA and NDA/BLA.

Skills

LC-MS/MS
Bioanalytical method development
Immunoassays
Ligand binding
Regulatory knowledge

Education

PhD or equivalent

Job description

Madrigal Pharmaceuticals Inc. is seeking a Senior Director of Bioanalytical Sciences to define and lead bioanalytical strategies across multiple programs.

You will partner with CROs to ensure high-quality data, oversee assay development and validation, and support regulatory submissions with robust scientific rationale. The role requires extensive experience in LC-MS/MS and immunoassay methods, with a track record of global regulatory compliance and cross-functional leadership in a fast-paced

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