Director, Clinical Pharmacology

Role Summary

Director, Clinical Pharmacology leads Clinical Pharmacology strategy across development programs for metabolic dysfunction-associated steatohepatitis (MASH). The role applies model-informed drug development (MIDD) to predict drug behavior, optimize dosing, and improve therapeutic outcomes, with a focus on dose selection, regulatory strategy, and integrating pharmacology plans across IND/POC, NDA/BLA/MAA, and post-approval activities. You will collaborate with cross-functional teams and contribute to regulatory submissions, scientific publications, and conference presentations.

Responsibilities

• Responsible for Clinical Pharmacology strategy within their projects
• 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
• 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
• Develops and execute model-informed drug development (MIDD) strategy, both through hands-on work and managing vendors
• Provide critical expertise to Business Development teams to assess external opportunities

Qualifications

• Director-level experience typically 12–15 years in related roles; postgraduate education may be included (e.g., PhD plus industry experience)
• Experience characterizing PK/PD properties of small molecules, siRNA, and biologic drugs
• Experience applying Clinical Pharmacology in early and late-stage drug development
• Experience in preparation of regulatory submissions (IND, CTA, PIP/PSP, NDA, BLA, MAA) and responding to health authority questions
• Prior experience in MASH and metabolic diseases is a plus but not required

Skills

• Demonstrated ability to work in a dynamic team-oriented environment
• Demonstrated stakeholder management with strong influence/leadership
• Quantitative data analysis and data visualization skills
• Experience programming and using data analysis and modeling tools (e.g., NONMEM, R, MATLAB, Monolix, Simcyp, GastroPlus, Phoenix WinNonlin, etc.)
• Demonstrated proficiency in one or more model informed drug development (MIDD) principles and analyses, including PopPK/PD, E-R, PBPK, QSP, MBMA
• Knowledgeable about bioanalytical methods, guidances, and issues commonly encountered is a plus
• A commitment to working as a team player and helping to establish new, optimal best practices and processes for high quality Clinical Pharmacology deliverables

Education

• Advanced Degree in pharmacology, pharmaceutical sciences, chemical/biomedical engineering or a related field (Ph.D. or PharmD)