Pharmacometrics Lead: PK/PD & MIDD Strategy

Jazz Pharmaceuticals, Inc.; Palo Alto (CA); A distancia; USD 164.000 - 246.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, dental and vision insurance

401(k) retirement savings plan

Flexible paid vacation

Bonus eligibility

Descripción de la vacante

Jazz Pharmaceuticals, Inc. is seeking a senior pharmacometrics leader to guide population PK/PK‑PD analyses across multiple programs.

You will design and execute exposure–response analyses, provide hands‑on modeling support, and help shape regulatory‑filing strategies in collaboration with cross-functional teams. The role requires a PhD with 5+ years of experience, strong communication skills, and the ability to navigate a fast-paced, matrixed environment.

Formación

• PhD with 5+ years of clinical PK/PK-PD data analysis experience.
• Strong knowledge of clinical pharmacology and pharmacometrics principles.
• Experience with regulatory interactions is a plus.
• Excellent written and oral communication and presentation skills.
• Ability to work in a fast-paced, matrixed environment.

Responsabilidades

• Develop pharmacometrics strategy for multiple programs.
• Design, perform, interpret and report population PK, PK/PD, and exposure–response analyses.
• Provide hands-on modeling and simulation support for development projects.
• Prepare CSRs and regulatory documents (INDs, NDAs, IBs) and contribute to regulatory filings.
• Plan, prepare and review drug development plans and regulatory submissions.
• Collaborate with cross-functional teams to implement Model-Informed Drug Development (MIDD).

Conocimientos

Pharmacometrics

PK/PD analysis

Modeling & simulation

Communication skills

Cross-functional collaboration

Independent work

Educación

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

Herramientas

NONMEM

Monolix

Phoenix WinNonlin

R

GastroPlus

SimCYP

ADAPT

PK-Sim

Descripción del empleo

Jazz Pharmaceuticals, Inc. is seeking a senior pharmacometrics leader to guide population PK/PK‑PD analyses across multiple programs.

You will design and execute exposure–response analyses, provide hands‑on modeling support, and help shape regulatory‑filing strategies in collaboration with cross-functional teams. The role requires a PhD with 5+ years of experience, strong communication skills, and the ability to navigate a fast-paced, matrixed environment.