Executive Director, Pharmacometrics

Role Summary

Seeking an experienced Executive Leader to expand Clinical Pharmacology and Pharmacometrics capabilities. The on-site role provides strategic direction, team management, and execution of pharmacometric activities to support decision making in drug development and regulatory submissions. A strong track record in pharmacometric analysis for Phase 1-3 development and cross-functional collaboration with research, development, and regulatory teams is required.

Responsibilities

• Develop and implement pharmacometric strategies across drug development, including dose selection, study design, and lifecycle management.
• Provide scientific modeling input in interpretation and translation of preclinical information to clinical for novel indications and target tissues.
• Lead and mentor a team of pharmacometricians, ensuring their professional development and providing guidance on complex analyses.
• Partner with cross-functional teams (early development, clinical research, clinical pharmacology, biostatistics, regulatory affairs) to advance the portfolio against program goals.
• Lead the development and application of pharmacometric models to support dosing decisions, optimize trial designs, establish proof of concept and optimize clinical trial success.
• Engage with regulatory agencies and prepare and review pharmacometric reports and regulatory submission documents.
• Stay current with advances in pharmacometrics and share expertise within the organization.

Qualifications

• PhD or equivalent in clinical pharmacology, pharmacokinetics, or pharmacometrics
• 10+ years of pharmaceutical industry experience in drug discovery and development
• Expert knowledge of PK/PD, QSP and pharmacometric analyses
• Proficient in using modeling software such as R, NONMEM, SAS, MATLAB
• Ability to manage multiple programs
• Excellent problem solving skills with a strong innovative spirit
• Strong leadership and interpersonal skills with experience managing a team of pharmacometricians
• Excellent oral and written communication skills
• Experience with writing Clinical Pharmacology and Pharmacometrics documents supporting regulatory submissions