Associate Director, Clinical Pharmacology - Ophthalmic PK/PD

Bausch + Lomb; Austin (TX); On-site; USD 130,000 - 200,000; Full time

Job summary

Bausch + Lomb is seeking a highly motivated translational scientist to lead PK/PD, pharmacometrics, and clinical pharmacology efforts across Rx ophthalmic and consumer eye health programs. The role drives study design, modeling, and regulatory document preparation to support drug development decisions.

Candidates will oversee nonclinical/clinical PK studies, ensure adherence to ICH and FDA/EMA guidelines, and collaborate with R&D, regulatory, and management teams to shape a best-in-class

Qualifications

• PhD in Pharmaceutical Sciences, Clinical Pharmacology, Pharmacometrics, Pharmacokinetics, Pharmacology, Biomedical Engineering, or related discipline with typically 6+ years of relevant experience.
• Experience with PK, PBPK, PK/PD, pharmacometrics or systems pharmacology, and/or drug metabolism and transporters. Ophthalmic drug development, topical/ocular PK, or ocular pharmacology experience is strongly preferred.

Responsibilities

• Leads clinical pharmacology, PK, PD, and pharmacometrics activities across the Rx ophthalmic pipeline and consumer eye health pipeline.
• Contributes to action plans for candidate selection, first-in-human strategy, dose selection and justification, life-cycle management.
• Provides overall clinical pharmacology timelines and deliverables to inform portfolio prioritization and resourcing decisions.
• Leads authoring of pharmacokinetics and clinical pharmacology sections of regulatory documents including IND/CTA, IB, and NDA/MAA/505(b)(2).
• Ensures alignment with ICH, FDA, EMA, and other applicable guidance for ophthalmic and systemic products.

Skills

PK/PD leadership

Clinical pharmacology

Pharmacokinetics/pharmacometrics

Regulatory strategy

Cross-functional collaboration

Education

PhD in Pharmaceutical Sciences or related

Tools

NONMEM

Monolix

Phoenix WinNonlin

NLME

R

Simcyp

GastroPlus

MATLAB

Job description

Bausch + Lomb is seeking a highly motivated translational scientist to lead PK/PD, pharmacometrics, and clinical pharmacology efforts across Rx ophthalmic and consumer eye health programs. The role drives study design, modeling, and regulatory document preparation to support drug development decisions.

Candidates will oversee nonclinical/clinical PK studies, ensure adherence to ICH and FDA/EMA guidelines, and collaborate with R&D, regulatory, and management teams to shape a best-in-class