Senior Director, Bioanalysis
Madrigal Pharmaceuticals
August 20, 2026
Remote friendly (Conshohocken, PA)
United States
Clinical Research and Development
Position Specific Responsibilities
- Define and implement bioanalytical strategies across a portfolio of programs through external partnerships for all phases of clinical and nonclinical development.
- Select, manage, and evaluate CRO partners to ensure high-quality delivery, timeline adherence, and budget performance.
- Develop and implement a scalable CRO partnering strategy (assay transfer, cross-validation, lifecycle management).
- Oversee assay development, qualification, validation, and sample analysis conducted by external partners.
- Develop bioanalytical strategy for all modalities in the preclinical and clinical portfolio (e.g., small molecules, siRNA, emerging therapeutic platforms).
- Ensure bioanalytical activities meet global regulatory requirements (FDA, EMA, ICH guidelines, including ICH M10; GLP/GCP as applicable).
- Review and approve bioanalytical documentation (protocols, validation/study reports, stability/interference assessments) ensuring data integrity.
- Lead issue identification and resolution to continuously improve CRO performance and data quality.
- Partner cross-functionally with Clinical Operations, Translational Medicine, Regulatory, and other R&D functions.
- Contribute to and lead bioanalytical strategy for regulatory submissions (IND/CTA, NDA/BLA) including regulator engagement.
- Serve as internal thought leader/subject matter expert; represent the function externally via conferences/publications/collaborations.
Specialized Knowledge & Skills
- Required: LC-MS/MS expertise for quantitative bioanalysis in biological matrices.
- Required: bioanalytical assay development and validation expertise.
- Preferred: hybridization-based assays, ligand binding assays, immunoassays.
- Required: global regulatory expectations for bioanalytical methods/data.
Educational Requirements
- Advanced degree preferred (Ph.D. or similar) in analytical/organic/pharmaceutical sciences or related field.
Experience
- Senior Director level: >15 years experience (postgraduate training may be included).
- Experience supporting clinical and nonclinical development.
- Proven success leading bioanalytical activities in an outsourced/CRO-based model.
- Strong scientific judgment balancing rigor, speed, and risk; effective cross-functional communication.
Application Instructions
- Apply via the Madrigal Careers site (applications accepted on an ongoing basis).
- Define and implement bioanalytical strategies across a portfolio of programs through external partnerships for all phases of clinical and nonclinical development.
- Select, manage, and evaluate CRO partners to ensure high-quality delivery, timeline adherence, and budget performance.
- Develop and implement a scalable CRO partnering strategy (assay transfer, cross-validation, lifecycle management).
- Oversee assay development, qualification, validation, and sample analysis conducted by external partners.
- Develop bioanalytical strategy for all modalities in the preclinical and clinical portfolio (e.g., small molecules, siRNA, emerging therapeutic platforms).
- Ensure bioanalytical activities meet global regulatory requirements (FDA, EMA, ICH guidelines, including ICH M10; GLP/GCP as applicable).
- Review and approve bioanalytical documentation (protocols, validation/study reports, stability/interference assessments) ensuring data integrity.
- Lead issue identification and resolution to continuously improve CRO performance and data quality.
- Partner cross-functionally with Clinical Operations, Translational Medicine, Regulatory, and other R&D functions.
- Contribute to and lead bioanalytical strategy for regulatory submissions (IND/CTA, NDA/BLA) including regulator engagement.
- Serve as internal thought leader/subject matter expert; represent the function externally via conferences/publications/collaborations.
Specialized Knowledge & Skills
- Required: LC-MS/MS expertise for quantitative bioanalysis in biological matrices.
- Required: bioanalytical assay development and validation expertise.
- Preferred: hybridization-based assays, ligand binding assays, immunoassays.
- Required: global regulatory expectations for bioanalytical methods/data.
Educational Requirements
- Advanced degree preferred (Ph.D. or similar) in analytical/organic/pharmaceutical sciences or related field.
Experience
- Senior Director level: >15 years experience (postgraduate training may be included).
- Experience supporting clinical and nonclinical development.
- Proven success leading bioanalytical activities in an outsourced/CRO-based model.
- Strong scientific judgment balancing rigor, speed, and risk; effective cross-functional communication.
Application Instructions
- Apply via the Madrigal Careers site (applications accepted on an ongoing basis).