Associate Director, Pharmacometrics

Jazz Pharmaceuticals • Palo Alto, CA

8d • $164,000 - $246,000 • Remote

About The Position

This position leads efficient and innovative population pharmacokinetic (PK), PK/PD, and exposure-response planning, analysis, interpretation, and reporting in support of international drug development programs. Working across functions, the Associate Director leads pharmacometrics strategy for multiple Jazz portfolio products, from research through registration and beyond.

The role provides hands-on modeling and simulation support for development projects, including dose selection and optimization. It also contributes to clinical study design and regulatory strategy, prepares and reviews development plans and regulatory filings, responds to agency questions, and coordinates consultants and vendors. The role works with cross-functional teams to integrate Model Informed Drug Development (MIDD) principles.

Requirements

• PhD in pharmaceutical sciences, biomedical engineering, clinical pharmacology, or mathematical/statistical sciences.
• At least 5 years of experience with clinical pharmacokinetic and pharmacokinetic-pharmacodynamic data analysis.
• Strong understanding of clinical pharmacology, pharmacometrics principles, and the drug development process.
• Prior experience performing modeling and simulation using PK/PD analysis software.
• Ability to work independently and collaboratively in a multidisciplinary team environment.
• Ability to succeed in a fast-paced, highly matrixed work environment.
• Excellent written and oral communication skills, including presentation skills.
• Embody and model Jazz core values.

Nice To Haves

• Experience in regulatory agency interactions.

Responsibilities

• Develop pharmacometrics strategies for multiple programs.
• Design, perform, interpret, and report population PK, PK/PD, and exposure-response analyses.
• Provide hands-on population PK and PK/PD modeling and simulation support for development projects, including dose selection and optimization.
• Contribute to clinical study protocol design, data analysis and interpretation, and study reporting, including preparation of clinical study reports and regulatory documents.
• Determine scope, design, planning, and analysis for Phase 1–4 pharmacokinetic and pharmacodynamic studies, including development of population PK models and PK/PD analyses needed for development and regulatory purposes.
• Plan, prepare, and review drug development plans and regulatory filings.
• Contribute relevant sections of regulatory submissions, including IND and NDA/BLA documents.
• Address queries from regulatory agencies during reviews and inspections.
• Identify and manage consultants and vendors supporting pharmacometrics analyses.
• Participate effectively on cross-functional teams to integrate MIDD principles.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• 401(k) retirement savings plan
• Flexible paid vacation
• Potential eligibility for a discretionary annual cash bonus or incentive compensation, depending on the role and plan terms
• Potential eligibility for discretionary equity grants

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree