Executive Director, Head of Pharmacometrics

Role Summary

Executive Director, Pharmacometrics leading pharmacometric activities, strategy, and team management to support drug development and regulatory submissions at Alnylam.

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 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