Director, Clinical Pharmacology

Role Summary

Director, Clinical Pharmacology. We are seeking a highly skilled Clinical Pharmacologist to join our R&D team to lead Clinical Pharmacology strategy, develop and implement model-informed drug development (MIDD) plans, and contribute to regulatory submissions for programs from IND through NDA/BLA/MAA and post-approval activities.

Responsibilities

• Responsible for Clinical Pharmacology strategy within projects
• Represent Clinical Pharmacology and contribute to integrated strategy on development teams, governance meetings, and regulatory engagement with health authorities
• Serve as a Clinical Pharmacology subject matter expert; develop, review, and approve Clinical Pharmacology content across company documents
• Support strategy for dose selection, dose justification, and regulatory filings
• Assess and inform bioanalytical planning and methods
• Lead design of 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, including vendor management
• Provide expertise to Business Development to assess external opportunities

Qualifications

• Advanced Degree in pharmacology, pharmaceutical sciences, chemical/biomedical engineering or related field (Ph.D. or PharmD)
• 12-15 years of experience at Director level, with relevant industry background
• Experience characterizing PK/PD properties of small molecules and biologics
• Experience applying Clinical Pharmacology in early and late-stage drug development
• Experience preparing regulatory submissions (IND, CTA, PIP/PSP, NDA, BLA, MAA) and responding to health authorities
• Prior experience in MASH/metabolic diseases is a plus but not required

Skills

• Ability to work in a dynamic, team-oriented environment
• Stakeholder management with strong influence/leadership
• Quantitative data analysis and data visualization skills
• Proficiency with data analysis and modeling tools (e.g., NONMEM, Phoenix WinNonlin, R, MATLAB, Monolix, SAS)
• Proficiency in MIDD principles and analyses (PopPK/PD, E-R, PBPK, QSP, MBMA)
• Knowledge of bioanalytical methods and associated guidances is a plus
• Team-oriented mindset and ability to establish high-quality Clinical Pharmacology deliverables

Education

• Advanced degree (Ph.D. or PharmD) in pharmacology, pharmaceutical sciences, or related field