Senior Director, Bioanalysis

Madrigal Pharmaceuticals Inc.; Conshohocken (Montgomery County); Sur place; USD 241 000 - 295 000; Plein temps

Avantages offerts par ce poste

Equity

Comprehensive benefits

401(k) employer match

Employee Assistance Program (EAP)

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

LC-MS/MS

Bioanalytical method development

Immunoassays

Ligand binding

Regulatory knowledge

Formation

PhD or equivalent

Description du poste

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.

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 $241,000 - $295,000 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.

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.

Unsolicited resumes from agencies should not be forwarded to Madrigal. Madrigal will not be responsible for any fees arising from the use of resumes through this source. Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and the agency has been established.