Remote Associate Director, Clinical Pharmacology

Fortvita Biologics; United States; Hybrid; USD 180,000 - 240,000; Full time

Job summary

Fortvita Biologics in the San Francisco Bay Area is seeking an Associate Director, Clinical Pharmacology, to lead the design and execution of clinical pharmacology studies, providing PK, PD, and biomarker data to inform development. You will collaborate with clinical development, regulatory affairs, and translational research teams across early- and late-phase studies.

The role emphasizes PK/PD modeling, dose optimization, and regulatory interactions with FDA/EMA, while guiding CROs and external

Qualifications

• PhD, PharmD, or MD with focus on clinical pharmacology or PK/PD.
• Experience leading design and execution of clinical pharmacology studies.
• Knowledge of regulatory requirements (FDA/EMA).

Responsibilities

• Lead design and execution of PK/PD studies across trial phases.
• Analyze PK/PD data and biomarker results to guide dose selection.
• Support regulatory submissions (IND/NDA/BLA) with clinical pharmacology input.
• Collaborate with clinical development, translational research, and biostatistics.
• Apply PK/PD modeling to optimize dosing regimens.
• Manage CROs and external partners for pharmacology activities.
• Contribute to a high-performing clinical pharmacology team.
• Ensure GCP/ICH compliance in all activities.

Skills

PK/PD modeling

Data analysis

Regulatory knowledge

Cross-functional collaboration

Communication skills

Education

PhD/PharmD/MD in clinical pharmacology

Tools

NONMEM

R

Phoenix WinNonlin

Job description

Fortvita Biologics in the San Francisco Bay Area is seeking an Associate Director, Clinical Pharmacology, to lead the design and execution of clinical pharmacology studies, providing PK, PD, and biomarker data to inform development. You will collaborate with clinical development, regulatory affairs, and translational research teams across early- and late-phase studies.

The role emphasizes PK/PD modeling, dose optimization, and regulatory interactions with FDA/EMA, while guiding CROs and external