Director, PBPK & Translational Pharmacokinetics

Eli Lilly and Company; Boston (MA); Presencial; USD 177 000 - 284 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

401(k) plan

Pension program

Health benefits

Resumo da oferta

Centessa Pharmaceuticals is seeking an experienced Director, Translational Pharmacokinetics – DMPK to lead PK modeling for early-stage programs across the portfolio.

You will develop PBPK models to simulate ADME/DDI and evolve PK/PD models with nonclinical and clinical data, supporting FIH dose projections and regulatory submissions. Collaboration across functions is essential for model validation and decision-making.

Qualificações

• PhD or equivalent advanced degree.
• 12+ years of industry experience in PBPK/PKPD modeling and FIH dose projections.
• Experience supporting IND-enabling programs and regulatory submissions.
• Solid understanding of ADME principles.
• Proficiency with PK modeling software (Simcyp, GastroPlus, Phoenix WinNonlin, NONMEM).
• Ability to thrive in a collaborative, matrixed biotechnology environment.

Responsabilidades

• Design and validate PBPK models to simulate ADME and DDI.
• Develop PKPD models using nonclinical and clinical data.
• Support FIH dose projections for candidates progressing into clinical development.
• Provide regulatory-support simulations and participate in regulatory interactions.
• Collaborate with cross-functional teams across DMPK, clinical pharmacology, CMC, and regulatory affairs.

Conhecimentos

PBPK modeling

PKPD modeling

IND-enabling support

Cross-functional leadership

Data integration

Formação académica

PhD, PharmD, or equivalent advanced degree

Ferramentas

Simcyp

GastroPlus

Phoenix WinNonlin

NONMEM

Descrição da oferta de emprego

Centessa Pharmaceuticals is seeking an experienced Director, Translational Pharmacokinetics – DMPK to lead PK modeling for early-stage programs across the portfolio.

You will develop PBPK models to simulate ADME/DDI and evolve PK/PD models with nonclinical and clinical data, supporting FIH dose projections and regulatory submissions. Collaboration across functions is essential for model validation and decision-making.