Sarepta Therapeutics · 1 day ago
Senior Director, Quantitative & Clinical Pharmacology
Cambridge, MA
Full-time
Hybrid
Director/Executive
$222K/yr - $278K/yr
10+ years expSarepta Therapeutics is at the forefront of genetic medicine, focusing on Duchenne muscular dystrophy and other diseases. They are seeking a Senior Director to lead clinical pharmacology and pharmacometrics strategies throughout clinical development, managing a team of scientists and ensuring regulatory compliance.
BiotechnologyGeneticsHealth CareTherapeutics
No H1B
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
Qualification
Required
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
Proven success in regulatory interactions from IND through registration
Demonstrated success in leading and building high-performing teams
Strong commitment to people development
Excellent communication, multitasking, and collaboration skills in cross-functional and matrixed team environments
Preferred
rare disease drug development experience
oligonucleotide experience
Benefits
Physical and Emotional Wellness
Financial Wellness
Support for Caregivers
Company
Sarepta Therapeutics
Sarepta Therapeutics focuses on the discovery and development of precision genetic medicine to treat rare diseases.
501-1000 employees
Funding
Current Stage
Public CompanyTotal Funding
$2.88BKey Investors
Michael Andrew ChambersPharmakon AdvisorsMidCap Financial
2025-12-11Post Ipo Debt· $291.4M
2025-08-21Post Ipo Equity
2025-08-21Post Ipo Debt· $602M
Leadership Team
Ian Estepan
Executive Vice President, Chief Financial Officer
K
Kathy Behrens Wilsey
Director
Recent News
2026-01-24
Genetic Engineering News
2026-01-23
Company data provided by crunchbase