Director of Quantitative Clinical Pharmacology & Strategy

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

Benefits offered by this job

Physical Wellness

Financial Wellness

Caregiver Support

Job summary

Sarepta Therapeutics in the United States is seeking a Director of Quantitative & Clinical Pharmacology to lead pharmacology and pharmacometrics across early through late-stage development, with emphasis on dose selection and PK/PD modeling.

The role drives model-based analyses (population PK, PK/PD, meta-analysis) and serves as the functional lead for global regulatory strategies and HA engagements, collaborating across translational teams and regulatory bodies.

Qualifications

• PhD in Pharmaceutical Sciences, mathematics/engineering or related field with 7 years in clinical pharmacology or pharmacometrics.
• Strong understanding of clinical pharmacology principles and hands-on PK/PD modeling.
• Experience interacting with regulatory agencies and clinical development teams.
• Excellent communication, multitasking, and collaboration skills.

Responsibilities

• Lead quantitative pharmacology strategies across all stages from development to registration.
• Provide clinical pharmacology expertise in translational development, protocol prep, execution, and data review.
• 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.

Skills

PK/PD modeling

Regulatory interactions

Communication

Multitasking

Collaboration

Education

PhD in Pharmaceutical Sciences

Mathematics/Engineering related field

Tools

NONMEM

R

Job description

Sarepta Therapeutics in the United States is seeking a Director of Quantitative & Clinical Pharmacology to lead pharmacology and pharmacometrics across early through late-stage development, with emphasis on dose selection and PK/PD modeling.

The role drives model-based analyses (population PK, PK/PD, meta-analysis) and serves as the functional lead for global regulatory strategies and HA engagements, collaborating across translational teams and regulatory bodies.