Director, Clinical Pharmacology

Madrigal Pharmaceuticals • Waltham, PA

1d

About The Position

Madrigal is seeking an experienced Clinical Pharmacologist to provide strategic and scientific leadership for clinical pharmacology across all stages of drug development. The role develops integrated strategies addressing dose selection, pharmacokinetics, pharmacodynamics, exposure-response, intrinsic and extrinsic factors, drug-drug interactions, cardiac safety, special populations, and regulatory submissions. It also advances modern quantitative approaches, including model-informed drug development (MIDD), to optimize programs from First-in-Human through registration and life-cycle management.

The Director collaborates with Clinical Development, Translational Medicine, Biostatistics, Regulatory Affairs, Medical Writing, and external partners to support development and regulatory decisions. The role also contributes to scientific publications and conference presentations.

Requirements

• 12–15 years of experience at the Director level; relevant postgraduate education may be included in the experience calculation.
• Experience characterizing pharmacokinetic and pharmacodynamic (biomarker, safety, and efficacy) properties of small molecule, siRNA, and biologic drugs.
• Experience applying Clinical Pharmacology in early- and late-stage drug development.
• Experience preparing regulatory submissions such as IND, CTA, PIP/PSP, NDA, BLA, and MAA, and responding to health authority questions.
• Strong scientific foundation in Clinical Pharmacology, pharmacokinetics, pharmacodynamics, and quantitative pharmacology.
• Deep understanding of mechanisms underlying drug disposition.
• Demonstrated ability to lead 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 and regulatory expectations, including FDA, EMA, and ICH.
• Ability to work in a dynamic, team-oriented environment, with demonstrated stakeholder management and strong influence and leadership.
• Quantitative data analysis and data visualization skills.
• Demonstrated proficiency guiding one or more MIDD principles and analyses, including PopPK/PD, E-R, PBPK, QSP, and MBMA.
• Commitment to teamwork and helping establish optimal best practices and processes for high-quality Clinical Pharmacology deliverables.

Nice To Haves

• Advanced degree in pharmacology, pharmaceutical sciences, biomedical engineering, or a related field (Ph.D., PharmD, or similar) preferred.
• Knowledge of bioanalytical methods, guidances, and commonly encountered issues.
• Experience programming and using data analysis and modeling tools such as NONMEM, R, MATLAB, Monolix, Simcyp, GastroPlus, or Phoenix WinNonlin.
• Prior experience in MASH and metabolic diseases.

Responsibilities

• Develop and execute integrated Clinical Pharmacology strategies from 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 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, including associated data analysis and reporting.
• Provide input to Phase 1–4 clinical study design and registrational strategy.
• Develop and execute MIDD strategy, managing vendors and potentially performing hands-on work.
• Provide clinical pharmacology expertise to Business Development teams assessing external opportunities.
• Contribute to scientific publications and presentations at scientific conferences.

Benefits

• Equity for all employees.
• Flexible paid time off.
• Medical, dental, vision, and life/disability insurance.
• 401(k) offerings, including traditional and Roth options and employer match.
• Voluntary benefits, including supplemental life insurance and legal services.
• Mental health benefits through the Employee Assistance Program for employees and their family.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: No Education Listed