Director, Clinical Pharmacology
$228.07k - $264.39kMadrigal Pharmaceuticals
Madrigal Pharmaceuticals seeks an experienced Clinical Pharmacologist to lead clinical pharmacology strategy across drug development stages, from early studies through post-marketing management. The role combines strategic oversight with quantitative approaches including model-informed drug development to support regulatory submissions and development decisions.
Responsibilities
- Develop and execute integrated clinical pharmacology strategies from First-in-Human through post-marketing phases
- Lead dose selection, optimization, and justification using clinical pharmacology data across development programs
- Design, oversee, and interpret Phase 1 and dedicated clinical pharmacology studies and analyses
- Represent clinical pharmacology expertise in regulatory engagements, governance meetings, and cross-functional teams
- Develop and manage model-informed drug development strategy including vendor management and data analysis
Requirements
- Advanced degree (Ph.D., PharmD, or equivalent) in pharmacology, pharmaceutical sciences, or related field
- 12-15 years of combined postgraduate education and relevant industry experience
- Expertise in pharmacokinetics, pharmacodynamics, dose selection, and exposure-response analyses
- Experience designing and interpreting dedicated clinical pharmacology studies (food effects, DDI, organ impairment, QT)
- Proficiency with model-informed drug development principles and quantitative analysis tools (NONMEM, R, MATLAB, Simcyp, etc.)
- Knowledge of global regulatory guidance (FDA, EMA, ICH) and experience with regulatory submissions
- Strong stakeholder management and team leadership capabilities
Vacancy posted a month ago
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