Director, Quantitative Clinical Pharmacology: PK/PD Modeling & Strategy

About the role

The Director of Quantitative & Clinical Pharmacology will be responsible to lead clinical pharmacology and pharmacometrics deliverables from early through late-stage clinical development (Ph3 and product registration), with an emphasis on clinical dose selection/refinement and predictive PK/PD modeling inclusive of population and statistically-based methodologies, as well as mechanistic and translational-focused approaches. This is a highly visible and team-facing role.

Responsibilities

• Drives the development and execution of the 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, study reports
• Responsible for model-based data analyses including population PK, PK/PD modeling and simulation, meta-analysis, 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 discipline, publishes manuscripts, presents at scientific conferences and scientific forums

Requirements

• 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, strong hands-on experience with PK/PD modeling analysis, and experience in regulatory interactions
• Excellent communication, multitasking, and collaboration skills
• Experience in NONMEM & R highly preferred
• siRNA and/or CNS experience is preferred
• Candidates must be authorized to work in the U.S.

Benefits

• Physical and Emotional Wellness
• Financial Wellness
• Support for Caregivers

For a full list of our comprehensive benefits, see our website: https://www.sarepta.com/join-us

Pay

$185,600 - $2