Director, Clinical Pharmacology

Madrigal Pharmaceuticals • Conshohocken, PA

2d • $228,074 - $264,393

About The Position

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.
We are seeking an experienced Clinical Pharmacologist to provide strategic and scientific leadership for clinical pharmacology across all stages of drug development. This individual will be responsible for developing integrated clinical pharmacology strategies that support dose selection, characterization of pharmacokinetics, pharmacodynamics, exposure-response characterization, intrinsic and extrinsic factors, drug-drug interactions, cardiac safety, special populations, and regulatory submissions. The role combines Clinical Pharmacology with the opportunity to drive modern quantitative approaches, including model-informed drug development (MIDD), to optimize development programs from First-in-Human through registration and life-cycle management. The successful candidate will collaborate closely with Clinical Development, Translational Medicine, Biostatistics, Regulatory Affairs, Medical Writing, and external partners to deliver high-quality Clinical Pharmacology strategies that enable informed development and regulatory decision making. Additionally, the individual will contribute to the preparation of scientific publications and presentations at scientific conferences.

Requirements

• Strong scientific foundation in Clinical Pharmacology, pharmacokinetics, pharmacodynamics, and quantitative pharmacology
• Deep understanding of mechanisms underlying drug disposition
• Demonstrated capabilities leading dose selection, dose optimization, exposure-response analyses, and benefit-risk assessment
• Experience designing and interpreting dedicated Clinical Pharmacology studies, including food effect, bioavailability, DDI, organ impairment, QT, and special population studies
• Knowledge of global Clinical Pharmacology guidance, including FDA, EMA, ICH, and related regulatory expectations
• Demonstrated ability to work in a dynamic team-oriented environment
• Demonstrated stakeholder management with strong influence/leadership
• Quantitative data analysis and data visualization skills
• Demonstrated proficiency in guiding one or more model informed drug development (MIDD) principles and analyses, including PopPK/PD, E-R, PBPK, QSP, MBMA
• Knowledgeable about bioanalytical methods, guidances, and issues commonly encountered is a plus
• A commitment to working as a team player and helping to establish new, optimal best practices and processes for high quality Clinical Pharmacology deliverables
• Experience programming and using data analysis and modeling tools a plus (e.g., NONMEN, R, MATLAB, Monolix, Simcyp, GastroPlus, Phoenix WinNonlin, etc.)
• Advanced Degree in pharmacology, pharmaceutical sciences, biomedical engineering or a related field preferred (Ph.D., PharmD, or similar)
• 12-15 years of experience
• Postgraduate education may be included. For example, a five-year PhD program in a relevant discipline combined with approximately 7 years of relevant industry experience may suitably qualify an applicant.
• Experience in characterizing the pharmacokinetic and pharmacodynamic (biomarker/safety/efficacy) properties of small molecule, siRNA, and biologic drugs
• Experience in the application of Clinical Pharmacology in early and late-stage drug development
• Experience in preparation of regulatory submissions (such as IND, CTA, PIP/PSP, NDA, BLA, MAA) and responding to questions from health authorities

Nice To Haves

• Prior experience in MASH and metabolic diseases is a plus but not required

Responsibilities

• Develop and execute integrated Clinical Pharmacology strategies spanning First-in-Human through post-marketing development, and guide development plans
• Represent Clinical Pharmacology and contribute to integrated strategy on development teams, at governance meetings, and in regulatory engagement with health authorities
• Serve as a Clinical Pharmacology subject matter expert
• Develop, review, and approve Clinical Pharmacology scientific content and conclusions across relevant company documents and activities, supporting INDs, NDAs, BLAs, MAAs, PSPs/PIPs, and post-marketing commitments
• Lead dose selection, dose optimization, dose justification, and dosing recommendations using integrated clinical pharmacology data
• Assess and inform bioanalytical planning and methods
• Design, oversee, interpret, and report Phase 1 and dedicated Clinical Pharmacology studies and associated data analysis, interpretation, and reporting
• Provide input to Phase 1-4 clinical study design and registrational strategy
• Develop and execute model-informed drug development (MIDD) strategy, through managing vendors and potentially through hands-on work
• Provide critical expertise to Business Development teams to assess external opportunities

Benefits

• Equity offers meaningful opportunity allowing our employees to share in the success they help create.
• All employees receive equity, which we believe reinforces our ownership culture.
• 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.
• flexible paid time off
• medical, dental, vision and life/disability insurance
• 401(k) offerings (i.e., traditional, Roth, and employer match) in accordance with applicable plans.
• supplemental life insurance
• legal services
• mental health benefits through our Employee Assistance Program for employees and their family.

What This Job Offers

• Job Type: Full-time
• Career Level: Director