Director, Clinical Pharmacology

About the role

Madrigal is 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.

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

Qualifications

• 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.)

Education & Experience

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

Pay

• Base salary range: $228,074 - $264,393 per year
• All full-time employees receive equity

Benefits

• Flexible paid time off
• Medical, dental, vision and life/disability insurance
• 401(k) offerings (traditional, Roth, and employer match)
• Additional voluntary benefits like supplemental life insurance, legal services, and other offerings
• Mental health benefits through Employee Assistance Program for employees and their family