Senior Director, Bioanalysis

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 a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH. Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c). Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration.

To support our continued growth, we are strengthening our workforce strategy to ensure we have the right talent, at the right time, in the right way. 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

Compensation and Benefits

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.

• 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.
• Additional voluntary benefits like supplemental life insurance, legal services, and other offerings.
• Mental health benefits through our Employee Assistance Program for employees and their family.
• Other benefits in accordance with applicable federal, state, and local laws.

We are committed to providing reasonable accommodations for individuals with disabilities throughout the hiring process. If you need assistance, please contact [e-mail].

Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law.

Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law.

Join our growing team focused on transforming the treatment of people with liver diseases. Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law.