Senior Director - Translational Pharmacology

Senior Director – Translational Pharmacology

PhD in Pharmaceutical Sciences, Pharmacology or related field with ≥ 10 years of experience working in biotech or pharmaceutical industry
Expertise in pharmacology, ADME/DMPK, IVIVE and translational PK/PD principles
Strong hands-on experience in modeling and data analytics
Proven success in regulatory interactions from IND through registration
Demonstrated success in leading and building high-performing teams
Excellent communication, multitasking, and collaboration skills in cross-functional and matrixed team environments

Lead Translational Pharmacology team across all modalities (RNA and GT) and therapeutic areas at Sarepta
Lead the development and execution of 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
Lead the strategy, 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
Functional SME/lead for global regulatory strategies and regulatory documents including study protocols and reports
Guide and manage effective communication of data and interpretation to teams and management, and contribute as functional SME in departmental and cross-departmental initiatives
Represent as functional lead for global regulatory activities and HA engagements (IND, 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 DMPK, ADME and Translational PK/PD methodologies for RNA and/or GT therapeutics
Advocate scientific leadership at external conferences and scientific community.