Director, Clinical Pharmacology

Madrigal Pharmaceuticals Inc.; Waltham (MA); On-site; USD 221,000 - 271,000; Full time

Benefits offered by this job

Equity

Flexible paid time off

Medical, dental, vision, life/disabil

401(k) with employer match

Employee Assistance Program

Job summary

Madrigal Pharmaceuticals Inc. is seeking an experienced Clinical Pharmacologist to provide strategic leadership across all stages of drug development.

The role focuses on dose selection, PK/PD characterization, exposure–response analyses, and MIDD to optimize development programs. Collaboration with Clinical Development, Regulatory Affairs, Biostatistics, and external partners will drive INDs, NDAs, BLAs, and post-marketing commitments.

Qualifications

• Advanced degree in pharmacology or related field; Ph.D., PharmD, or equivalent preferred.
• 12–15 years of director-level experience in industry or equivalent.
• Experience characterizing PK/PD and biomarker properties for small molecules, siRNA, and biologics.

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

Skills

Clinical pharmacology

Pharmacokinetics

Pharmacodynamics

MIDD

PopPK/PD

R

NONMEM

Monolix

Phoenix WinNonlin

Education

Ph.D., PharmD or equivalent

Tools

NONMEM

R

Monolix

Phoenix WinNonlin

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.

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.

Position Specific 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

Specialized Knowledge & Skills:

• 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.)

Educational Requirements:

Advanced Degree in pharmacology, pharmaceutical sciences, biomedical engineering or a related field preferred (Ph.D., PharmD, or similar)

Experience:

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

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 $221,000 - $271,000 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.