Director, Clinical Pharmacology

Madrigal Pharmaceuticals • Conshohocken, PA

2d • $221,000 - $271,000

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 a highly skilled and motivated Clinical Pharmacologist to join our dynamic research and development team. The ideal candidate will have also have experience in the application of model-informed drug development (MIDD) to predict drug behavior, optimize dosing, and improve therapeutic outcomes. Knowledge of bioanalytical guidelines, methods, and their assessment is also a plus. This position offers the opportunity to contribute to the development of innovative therapies in a growing pharmaceutical company focused on helping patients with metabolic dysfunction-associated steatohepatitis (MASH) and related metabolic diseases, and to work in a collaborative environment with a commitment to scientific excellence. This role potentially includes the optimization and implementation of clinical pharmacology plans, incorporating established and innovative approaches, to help advance early development programs through IND / clinical POC, late-stage development programs through NDA, BLA and MAA, and post approval activities. In this role, you will apply modeling and simulation techniques to support drug development, dose optimization, and regulatory submissions. Collaboration with cross-functional teams, including research scientists, clinical leads, medical writers, and regulatory experts, will be essential to integrate planning and analyses into overall drug development strategies. Additionally, you will contribute to the preparation of regulatory submissions, scientific publications, and presentations at scientific conferences.

Requirements

• Demonstrated ability to work in a dynamic team-oriented environment
• Demonstrated stakeholder management with strong influence/leadership
• Quantitative data analysis and data visualization skills
• Experience programming and using data analysis and modeling tools (e.g., NONMEN, R, MATLAB, Monolix, Simcyp, GastroPlus, Phoenix WinNonlin, etc.)
• Demonstrated proficiency in one or more model informed drug development (MIDD) principles and analyses, including PopPK/PD, E-R, PBPK, QSP, MBMA
• A commitment to working as a team player and helping to establish new, optimal best practices and processes for high quality Clinical Pharmacology deliverables
• Advanced Degree in pharmacology, pharmaceutical sciences, chemical/biomedical engineering or a related field (Ph.D. or PharmD).
• Please note this position as offered at the Director level entails 12-15 years of experience, and 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

• Knowledgeable about bioanalytical methods, guidances, and issues commonly encountered is a plus
• Prior experience in MASH and metabolic diseases is a plus but not required.

Responsibilities

• Responsible for Clinical Pharmacology strategy within their projects
• 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.
• Support strategy for dose selection, dose justification, and regulatory filings.
• Assess and inform bioanalytical planning and methods
• Lead design of Clinical Pharmacology studies and associated data analysis, interpretation, and reporting
• Provide input to Phase 1-4 clinical study design and registrational strategy
• Develops and execute model-informed drug development (MIDD) strategy, both through hands-on work and managing vendors
• Provide critical expertise to Business Development teams to assess external opportunities

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree