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

Sarepta Therapeutics•Cambridge, MA

8d•$185,600 - $232,000•Hybrid

About The Position

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.

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
Experience in regulatory interactions
Excellent communication, multitasking, and collaboration skills
Candidates must be authorized to work in the U.S.

Nice To Haves

Comfortable with ambiguity and candor
Relish challenging yourself
Place kindness and integrity at the forefront of how you approach your peers and work

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.