Director, Clinical Pharmacology
Madrigal Pharmaceuticals
August 20, 2026
Remote friendly (Conshohocken, PA)
United States
Clinical Research and Development
Position Specific Responsibilities
- Develop and execute integrated clinical pharmacology strategies spanning First-in-Human through post-marketing development.
- Represent Clinical Pharmacology on development teams, governance meetings, and with health authorities.
- Serve as Clinical Pharmacology subject matter expert.
- Develop, review, and approve clinical pharmacology scientific content supporting INDs/NDAs/BLAs/MAAs and PSPs/PIPs and post-marketing commitments.
- Lead dose selection, dose optimization, dose justification, and dosing recommendations.
- Assess and inform bioanalytical planning and methods.
- Design, oversee, interpret, and report Phase 1 and dedicated clinical pharmacology studies and analyses.
- Provide input to Phase 1–4 clinical study design and registrational strategy.
- Develop and execute model-informed drug development (MIDD) strategy (manage vendors and possibly hands-on).
- Provide expertise to Business Development to assess external opportunities.
Specialized Knowledge & Skills
- Strong foundation in clinical pharmacology, PK/PD, and quantitative pharmacology.
- Knowledge of drug disposition mechanisms.
- Experience with dose selection/optimization, exposure-response analyses, and benefit-risk assessment.
- Experience with dedicated clinical pharmacology studies (food effect, bioavailability, DDI, organ impairment, QT, special populations).
- Familiarity with global guidance (FDA/EMA/ICH).
- Quantitative data analysis/visualization; MIDD proficiency (e.g., PopPK/PD, E-R, PBPK, QSP, MBMA).
- Bioanalytical methods knowledge is a plus; programming tools a plus (NONMEM, R, MATLAB, Monolix, Simcyp, GastroPlus, Phoenix WinNonlin).
Educational Requirements
- Advanced degree (Ph.D., PharmD, or similar) in pharmacology/pharmaceutical sciences/biomedical engineering or related field preferred.
Experience
- Director-level: 12–15 years experience (postgraduate education may be included).
- Experience characterizing PK/PD properties of small molecules, siRNA, and biologics.
- Experience applying clinical pharmacology in early and late-stage development.
- Experience with regulatory submissions (IND/CTA/PIP-PSP/NDA/BLA/MAA) and responding to health authority questions.
- Prior MASH/metabolic disease experience is a plus.
Benefits
- Full-time employees receive comprehensive benefits including flexible paid time off, medical/dental/vision, life/disability insurance, and 401(k) (traditional/Roth/employer match), plus additional voluntary benefits and mental health support via Employee Assistance Program.
- Equity and base salary estimated at $228,074–$264,393/year.
Application Instructions
- Apply via the Madrigal Careers site (applications accepted on an ongoing basis).
- Develop and execute integrated clinical pharmacology strategies spanning First-in-Human through post-marketing development.
- Represent Clinical Pharmacology on development teams, governance meetings, and with health authorities.
- Serve as Clinical Pharmacology subject matter expert.
- Develop, review, and approve clinical pharmacology scientific content supporting INDs/NDAs/BLAs/MAAs and PSPs/PIPs and post-marketing commitments.
- Lead dose selection, dose optimization, dose justification, and dosing recommendations.
- Assess and inform bioanalytical planning and methods.
- Design, oversee, interpret, and report Phase 1 and dedicated clinical pharmacology studies and analyses.
- Provide input to Phase 1–4 clinical study design and registrational strategy.
- Develop and execute model-informed drug development (MIDD) strategy (manage vendors and possibly hands-on).
- Provide expertise to Business Development to assess external opportunities.
Specialized Knowledge & Skills
- Strong foundation in clinical pharmacology, PK/PD, and quantitative pharmacology.
- Knowledge of drug disposition mechanisms.
- Experience with dose selection/optimization, exposure-response analyses, and benefit-risk assessment.
- Experience with dedicated clinical pharmacology studies (food effect, bioavailability, DDI, organ impairment, QT, special populations).
- Familiarity with global guidance (FDA/EMA/ICH).
- Quantitative data analysis/visualization; MIDD proficiency (e.g., PopPK/PD, E-R, PBPK, QSP, MBMA).
- Bioanalytical methods knowledge is a plus; programming tools a plus (NONMEM, R, MATLAB, Monolix, Simcyp, GastroPlus, Phoenix WinNonlin).
Educational Requirements
- Advanced degree (Ph.D., PharmD, or similar) in pharmacology/pharmaceutical sciences/biomedical engineering or related field preferred.
Experience
- Director-level: 12–15 years experience (postgraduate education may be included).
- Experience characterizing PK/PD properties of small molecules, siRNA, and biologics.
- Experience applying clinical pharmacology in early and late-stage development.
- Experience with regulatory submissions (IND/CTA/PIP-PSP/NDA/BLA/MAA) and responding to health authority questions.
- Prior MASH/metabolic disease experience is a plus.
Benefits
- Full-time employees receive comprehensive benefits including flexible paid time off, medical/dental/vision, life/disability insurance, and 401(k) (traditional/Roth/employer match), plus additional voluntary benefits and mental health support via Employee Assistance Program.
- Equity and base salary estimated at $228,074–$264,393/year.
Application Instructions
- Apply via the Madrigal Careers site (applications accepted on an ongoing basis).