Director, Clinical Pharmacology & MIDD Strategy

Madrigal Pharmaceuticals Inc.; Waltham (MA); Sur place; USD 221 000 - 271 000; Plein temps

Avantages offerts par ce poste

Equity

Flexible paid time off

Medical, dental, vision, life/disabil

401(k) with employer match

Employee Assistance Program

Résumé du poste

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.

Responsabilités

• 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

Connaissances

Clinical pharmacology

Pharmacokinetics

Pharmacodynamics

MIDD

PopPK/PD

R

NONMEM

Monolix

Phoenix WinNonlin

Formation

Ph.D., PharmD or equivalent

Outils

NONMEM

R

Monolix

Phoenix WinNonlin

Description du poste

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.