Director of Quantitative Clinical Pharmacology (PK/PD)

Sarepta Therapeutics; Virginia; Hybride; USD 186 000 - 232 000; Plein temps

Avantages offerts par ce poste

Physical and Emotional Wellness

Financial Wellness

Support for Caregivers

Résumé du poste

Sarepta Therapeutics is seeking a Director of Quantitative & Clinical Pharmacology to lead dose selection, pharmacometric modeling, and regulatory strategies across early through late-stage development. This highly visible, team-facing role will guide PK/PD analyses and translational approaches.

Based on a hybrid site in the United States, the position offers collaboration with global teams, a competitive salary range, and emphasis on NONMEM, PK/PD modeling, and clear communication with

Qualifications

• PhD in Pharmaceutical Sciences, mathematics/engineering or related field with 7 years of experience working in clinical pharmacology or pharmacometrics.
• Strong understanding of clinical pharmacology principles, with hands-on PK/PD modeling experience.
• Excellent communication, multitasking, and collaboration skills.
• Experience in NONMEM and R is highly beneficial.

Responsabilités

• Drives the development and execution of quantitative pharmacology strategies across all stages of drug development through product registration.
• Leads clinical pharmacology expertise in clinical and translational development strategies, protocol preparation, study execution, data review/analysis, and study reports.
• Responsible for model-based data analyses including population PK, PK/PD modeling and simulation, meta-analysis, and disease modeling to inform clinical development.
• Serves as functional lead for global regulatory strategies and HA engagements.
• Maintains leading-edge knowledge in clinical pharmacology and pharmacometrics; publishes manuscripts and presents at conferences.

Connaissances

PK/PD modeling

Regulatory interactions

Formation

PhD in Pharmaceutical Sciences, mathematics/engineering or related field

Outils

NONMEM

R

Description du poste

Sarepta Therapeutics is seeking a Director of Quantitative & Clinical Pharmacology to lead dose selection, pharmacometric modeling, and regulatory strategies across early through late-stage development. This highly visible, team-facing role will guide PK/PD analyses and translational approaches.

Based on a hybrid site in the United States, the position offers collaboration with global teams, a competitive salary range, and emphasis on NONMEM, PK/PD modeling, and clear communication with