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 leading on-site strategic direction, team management, and execution of pharmacometric activities to support drug development and regulatory submissions. Guides modeling and simulation strategies for decision making across Phase 1–3 programs; collaborates with research, early development, clinical development, and regulatory teams.
Responsibilities
- Develop and implement pharmacometric strategies across drug development, including dose selection, study design, and lifecycle management.
- Provide scientific modeling-based 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