Executive Director, Pharmacometrics
Alnylam Pharmaceuticals
Full-time
On-site
Cambridge, MA
$289,000 - $391,000 USD yearly
Clinical Research and Development
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Role Summary
Executive Director, Pharmacometrics responsible for providing strategic direction, team management, and execution of pharmacometric activities to support drug development and regulatory submissions. Leads modeling and simulation strategies across Phase 1–3 programs and partners with research, development, and regulatory teams.
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