Executive Director, Pharmacometrics
About The Position
Seeking an experienced Head of Pharmacometrics to expand Clinical Pharmacology and Pharmacometrics capabilities within Alnylam. The Executive Director, Pharmacometrics is a 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.
Requirements
- 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
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.
Benefits
- comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match
- Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks.
- We also offer generous family resources and leave.
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What This Job Offers
Job Type
Full-time
Career Level
Executive
Education Level
Ph.D. or professional degree
Number of Employees
1,001-5,000 employees
