Associate Director, Pharmacometrics

This is a fully remote position, open to applicants in California, +1 more state.

📋 Description

• Formulate pharmacometrics strategies for a variety of programs.

• Design, conduct, interpret, and report on population pharmacokinetic (PK), pharmacokinetic/pharmacynamic (PK/PD), and exposure-response assessments.

• Offer practical population PK and PK/PD modeling and simulation assistance for development projects, including dosage selection and optimization.

• Create clinical study protocols and analyze as well as interpret study outcomes.

• Draft clinical study reports and regulatory documents, such as Investigational New Drug applications (INDs), New Drug Applications (NDAs), and Investigator’s Brochures (IBs).

• Define the scope, design, planning, and analysis for Phase 1–4 pharmacokinetic and pharmacodynamic studies.

• Develop suitable population PK models and PK/PD analyses to support development and regulatory goals through commercialization.

• Organize, prepare, and review drug development strategies and regulatory submissions.

• Contribute to relevant sections of IND and NDA/BLA regulatory submissions.

• Address inquiries from regulatory agencies during reviews and inspections.

• Identify and oversee consultants and vendors that support pharmacometrics analyses.

• Collaborate effectively within cross-functional teams to incorporate Model Informed Drug Development principles.

⛳️ Requirements

• PhD in pharmaceutical sciences, biomedical engineering, clinical pharmacology, or mathematical/statistical sciences.

• Over 5 years of experience in clinical pharmacokinetic and pharmacokinetic-pharmacodynamic data analysis.

• Deep understanding of clinical pharmacology, pharmacometrics principles, and the drug development process.

• Proficiency in modeling and simulation tasks using software for PK/PD analysis, such as NONMEM, Monolix, Phoenix WinNonlin, R, GastroPlus, SimCYP, ADAPT, or PK Sim.

• Experience interacting with regulatory agencies is advantageous.

• Capability to work both independently and collaboratively within a multidisciplinary team environment.

• Ability to thrive in a fast-paced, highly matrixed work environment.

• Exceptional written and oral communication abilities, including presentation skills.

• Demonstrate and embody Jazz's core values.

🏝️ Benefits

• Discretionary annual cash bonus or incentive compensation, based on the role.

• Discretionary equity grants under Jazz’s Long Term Equity Incentive Plan.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401k retirement savings plan.

• Flexible paid vacation.