Senior Director, Quantitative & Clinical Pharmacology

Sarepta Therapeutics•Cambridge, MA

3d•Hybrid

About The Position

This leadership role will be developing and executing translational, clinical pharmacology and pharmacometrics strategies and deliverables from early through late-stage clinical development. Key areas of emphasis will include but are not limited to clinical dose selection and refinement across all phases of clinical development, FIH and clinical pharmacology study designs, development and hands-on application of MIDD using population and statistically based methodologies, as well as mechanistic and translational PK/PD approaches. This role will manage a team of scientists and serve as a SME on programs.

Requirements

PhD in Clinical Pharmacology, Pharmacometrics, Pharmaceutical Sciences or related field with ≥ 10 years of experience working in biotech or pharmaceutical industry
Expertise in clinical pharmacology and pharmacometrics principles, strong hands-on experience in modeling and data analytics, and proven success in regulatory interactions from IND through registration
Demonstrated success in leading and building high-performing teams, with a strong commitment to people development
Excellent communication, multitasking, and collaboration skills in cross-functional and matrixed team environments
Candidates must be authorized to work in the U.S.

Nice To Haves

rare disease drug development experience preferred
oligonucleotide experience is preferred

Responsibilities

Lead clinical pharmacology and pharmacometrics workstreams in CNS diseases (rare disease drug development experience preferred)
Represent as therapeutic lead (oligonucleotide experience is preferred) and SME in clinical pharmacology strategies, clinical study protocol preparation, study execution, data review/analysis, and study reports
Lead the development and execution of translational and mechanistically based PK/PD modeling to enable identification of FIH dose, early characterization of efficacy and safety using biomarkers and disease animal models
Lead and execute pharmacometrics strategies across all stages of drug development including population PK, PK/PD modeling and simulations, meta-analysis, disease modeling to inform clinical development
Support non-clinical PK/PD, ADME and DMPK evaluations including strategy development, study design and execution, data analyses to inform lead optimization, candidate selection and nonclinical drug development
Represent as functional lead for global regulatory activities and HA engagements (NDA and/or BLA experience is a must)
Supervise, mentor and develop a team of high-performing scientists
Contribute to platform-based pharmacology activities across novel genetic modalities and disease indications
Encompass leading-edge knowledge in clinical pharmacology and pharmacometrics discipline, publish manuscripts
Advocate scientific leadership at external conferences and scientific community.