Head of Quantitative Clinical Pharmacology & Strategy

Sarepta Therapeutics; Maine; Hybrid; USD 186,000 - 232,000; Full time

Benefits offered by this job

Physical and Emotional Wellness

Financial Wellness

Support for Caregivers

Job summary

Sarepta Therapeutics seeks a Director of Quantitative & Clinical Pharmacology to lead pharmacometrics and clinical pharmacology deliverables from early development through product registration. The role emphasizes dose selection, PK/PD modeling, and translation-focused methods in a highly visible, team-facing capacity.

The candidate will drive model-based analyses, contribute to regulatory strategies, and stay at the forefront of the discipline, publishing and presenting findings while

Qualifications

• PhD in Pharmaceutical Sciences, mathematics/engineering or related field; 7+ years in clinical pharmacology or pharmacometrics
• Strong understanding of clinical pharmacology principles and PK/PD modeling; regulatory interactions experience preferred
• Excellent communication, multitasking and collaboration skills
• Experience with NONMEM and R highly preferred
• siRNA and/or CNS experience preferred

Responsibilities

• Lead quantitative pharmacology strategies across all stages of development through product registration
• Provide clinical pharmacology expertise in translational development; prepare protocols, execute studies, review data and reports
• Perform model-based analyses including population PK/PK-PD modeling, meta-analysis and disease modeling
• Serve as functional lead for global regulatory strategies and HA engagements
• Maintain cutting-edge knowledge; publish manuscripts and present at conferences

Skills

PK/PD modeling

Regulatory interactions

Communication, multitasking, teamwork

NONMEM

R

siRNA/CNS experience

Education

PhD in Pharmaceutical Sciences / mathematics or engineering

Tools

NONMEM

R

Job description

Sarepta Therapeutics seeks a Director of Quantitative & Clinical Pharmacology to lead pharmacometrics and clinical pharmacology deliverables from early development through product registration. The role emphasizes dose selection, PK/PD modeling, and translation-focused methods in a highly visible, team-facing capacity.

The candidate will drive model-based analyses, contribute to regulatory strategies, and stay at the forefront of the discipline, publishing and presenting findings while