Director, Translational PK & PBPK Modeling

BioSpace; Indianapolis (IN); Presencial; USD 177.000 - 284.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

401(k) plan

Pension

Vacation benefits

Medical, dental, vision benefits

Well-being programs

Descripción de la vacante

Centessa Pharmaceuticals is seeking an experienced Director, Translational Pharmacokinetics – DMPK to provide pharmacokinetic modeling leadership for early-stage development programs across the company's portfolio.

You will develop and validate physiologically based pharmacokinetic (PBPK) models to simulate drug absorption, distribution, metabolism, and excretion (ADME) and drug-drug interactions (DDI) in the body.

Formación

• PhD, PharmD, or equivalent advanced scientific degree.
• 12+ years of industry experience in modeling and simulation of PBPK and PKPD models, and FIH dose projections.
• Demonstrated experience supporting IND-enabling programs and regulatory submissions.
• A solid understanding of the principals of ADME.

Responsabilidades

• Model DevelopmentDesign and implement PBPK models that accurately represent drug behavior in biological systems
• Create and/or evolve PKPD models with nonclinical and clinical data
• Support FIH dose projection for selected drug candidates progressing into the clinic
• Data IntegrationIntegrate diverse experimental data, including pharmacokinetics and pharmacodynamics, to enhance model accuracy.
• Regulatory SupportProvide evidence-based simulations to support regulatory decisions and submissions including INDs, CTAs, IBs, briefing documents, regulatory responses, and health authority meeting materials
• CollaborateWork closely with cross-functional teams, including DMPK, clinical pharmacology, translation sciences, CMC, clinical development, regulatory affairs, and project management, to ensure comprehensive model validation.
• Mentor junior scientists and contribute to development of organizational capabilities.

Conocimientos

PBPK modeling

PKPD modeling

Regulatory submissions

IND experience

Cross-functional collaboration

Data evaluation

Educación

PhD/PharmD or equivalent

Herramientas

Simcyp

GastroPlus

Phoenix WinNonlin

NONMEM

Descripción del empleo

Centessa Pharmaceuticals is seeking an experienced Director, Translational Pharmacokinetics – DMPK to provide pharmacokinetic modeling leadership for early-stage development programs across the company's portfolio.

You will develop and validate physiologically based pharmacokinetic (PBPK) models to simulate drug absorption, distribution, metabolism, and excretion (ADME) and drug-drug interactions (DDI) in the body.