The Senior Director, Bioanalysis will provide strategic leadership and end-to-end accountability for bioanalytical sciences across a portfolio of clinical and nonclinical development programs. This individual will define and drive bioanalytical strategies that enable critical program decisions, ensuring generation of high-quality, regulatory-compliant data to support pharmacokinetic (PK) and pharmacodynamic (PD) evaluations.
Operating within a predominantly outsourced model, this individual oversees external bioanalytical partners and serves as a key scientific leader in bioanalytical sciences across the organization. This role has significant cross-functional influence, contributing to regulatory engagement and successful advancement of innovative therapeutics across modalities.
Position Specific Responsibilities:- Define and implement bioanalytical strategies across a portfolio of programs through external partnerships to support all phases of clinical and nonclinical development programs ensuring scientific and regulatory rigor as well as identifying and guiding needed innovation
- Select, manage, and evaluate CRO partners to ensure high-quality delivery, timeline adherence, and budget performance
- Develop and implement a scalable CRO partnering strategy, including assay transfer, cross-validation, and lifecycle management across programs
- Provide oversight of 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, and emerging therapeutic platforms
- Ensure all bioanalytical activities meet global regulatory requirements (FDA, EMA, ICH guidelines, including ICH M10; GLP/GCP as applicable)
- Review and approve bioanalytical documentation, including protocols, validation reports, study reports, and stability/interference assessments, ensuring data integrity and scientific rigor
- Lead issue identification and resolution, driving continuous improvement in CRO performance and data quality
- Partner cross-functionally with Clinical Operations, Translational Medicine, Regulatory, and other R&D functions to support program progression
- Contribute to and lead bioanalytical strategy for regulatory submissions (IND/CTA, NDA/BLA), including regulator engagement and responses
- Serve as the internal thought leader and subject matter expert in bioanalytical sciences, shaping platform and portfolio-level strategy
- Represent the bioanalytical function externally through scientific conferences, publications, and collaborations
- Results-oriented with strong execution and accountability
- Ability to thrive in a fast-paced, evolving development environment
Specialized Knowledge & Skills:- Comprehensive expertise in LC-MS/MS for quantitative bioanalysis in biological matrices is required
- Deep expertise in bioanalytical assay development and validation is required
- Familiarity with hybridization-based assays, ligand binding assays, and immunoassays is strongly preferred
- Thorough understanding of global regulatory expectations for bioanalytical methods and data is required
Educational Requirements:- Advanced degree in analytical chemistry, organic chemistry, pharmaceutical sciences or a related field preferred (Ph.D. or similar)
Experience:- Please note this position as offered at the Senior Director level entails >15 years of experience, and postgraduate education and training may be included
- Demonstrated experience supporting both clinical and nonclinical development programs
- Proven success leading bioanalytical activities in an outsourced/CRO-based model
- Strong scientific judgment with the ability to balance rigor, speed, and risk
- Effective communicator with demonstrated ability to influence cross-functional stakeholders
Madrigal's Total Rewards strategy is based on a biotech industry peer group comparator and is inclusive of base pay, bonus and equity. Our equity offers meaningful opportunity allowing our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization.
All employees receive equity, which we believe reinforces our ownership culture. Base salary is determined by several factors including the candidate's qualifications, skills, education, experience, business needs and market demands. As of the date of this posting, a good faith estimate of the current pay scale for this position, applicable to all candidates, is $273,366 - $314,989 per year. We comply with all applicable minimum wage laws.
All full-time employees receive equity, which reinforces our ownership culture and offers meaningful opportunity for our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization.
Full-time employees are also eligible for comprehensive benefits, including flexible paid time off, medical, dental, vision and life/disability insurance, and 401(k) offerings (i.e., traditional, Roth, and employer match) in accordance with applicable plans. We also offer additional voluntary benefits like supplemental life insurance, legal services, and other offerings. In addition, we offer mental health benefits through our Employee Assistance Program for employees and their family. The company also provides other benefits in accordance with applicable federal, state, and local laws.
