Director, Translational PK/PD & PBPK Modeling

Ladders; USA; Remote; USD 177.000 - 284.000; Vollzeit

Benefits dieser Stelle

401(k) plan

Pension

Medical, dental, vision and Rx

Flexible spending accounts

Life insurance

Well-being programs and fitness

Performance-based bonus

Zusammenfassung

Ladders is seeking a Director, Translational Pharmacokinetics - DMPK to shape PK strategy across a biotech pipeline. You will build PBPK and PKPD models translating preclinical and clinical data into actionable dosing, safety, and regulatory insights, guiding first-in-human planning and submissions.

The role is remote from the US and offers a competitive compensation package. A track record in IND-enabling work, cross-functional collaboration, and senior PK/PD modeling is required.

Qualifikationen

• PhD, PharmD, or equivalent advanced scientific degree.
• 12+ years of industry experience in PBPK and PKPD modeling.
• Experience with IND-enabling programs and regulatory submissions.
• Solid understanding of ADME principles.
• Proficiency in pharmacokinetic modeling software such as Simcyp and GastroPlus.
• Ability to critically evaluate experimental data.
• Experience in a collaborative biotechnology environment.

Aufgaben

• Design and implement PBPK models to simulate drug behavior.
• Create and evolve PKPD models using clinical and nonclinical data.
• Support first-in-human dose projections for drug candidates.
• Integrate diverse experimental data to improve model accuracy.
• Provide simulations for regulatory submissions and decision-making.
• Collaborate with cross-functional teams to validate models.
• Conduct simulations to predict drug-drug interactions and optimize dosing strategies.

Kenntnisse

PBPK modeling

PKPD modeling

IND-enabling programs

Regulatory submissions

ADME principles

Cross-functional collaboration

PK modeling software

Simcyp

GastroPlus

Data interpretation

DMPK strategy

Ausbildung

PhD, PharmD, or equivalent advanced degree

Tools

Simcyp

GastroPlus

Jobbeschreibung

Ladders is seeking a Director, Translational Pharmacokinetics - DMPK to shape PK strategy across a biotech pipeline. You will build PBPK and PKPD models translating preclinical and clinical data into actionable dosing, safety, and regulatory insights, guiding first-in-human planning and submissions.

The role is remote from the US and offers a competitive compensation package. A track record in IND-enabling work, cross-functional collaboration, and senior PK/PD modeling is required.