Executive Director, Head of Pharmacometrics

Role Summary

Seeking an experienced Head of Pharmacometrics to expand Clinical Pharmacology and Pharmacometrics capabilities within Alnylam.

The Executive Director, Pharmacometrics is an on-site, leadership role focused on providing strategic direction, team management, and execution of pharmacometric activities within Alnylam. This role involves guiding the development and application of modeling and simulation strategies to support decision making in drug development and regulatory submissions. A robust and rich experience in applying pharmacometric analysis supporting Phase 1-3 clinical development is preferred. The Executive Director, Pharmacometrics will partner with key stakeholders within research, early development, clinical development and regulatory for successful delivery of Alnylam Development portfolio.

Responsibilities

• Develop and implement pharmacometric strategies across drug development, including dose selection, study design, and lifecycle management.
• Provide scientific modeling based input in interpretion 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 Alnylam 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