SAREPTA

Director

• Lead clinical pharmacology and pharmacometrics deliverables from early through late-stage clinical development through Ph3 and product registration
• Drive development and execution of quantitative pharmacology strategies across all stages of drug development
• Lead clinical pharmacology expertise in clinical and translational development strategies, protocol preparation, study execution, data review/analysis, and study reports
• Conduct model-based data analyses including population PK, PK/PD modeling and simulation, meta-analysis, and disease modeling
• Serve as functional lead for global regulatory strategies and health authority engagements
• Maintain leading-edge knowledge, publish manuscripts, and present at scientific conferences and forums

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

Manager

• Support development and execution of Global Medical Affairs strategy for product launch and life-cycle management
• Identify data gaps and drive data generation initiatives, including IIS/SRA program participation
• Develop scientific narratives and analyze clinical, non-clinical, real-world, and post-hoc data
• Contribute to congress, symposia, advisory board, and expert committee strategy and content
• Collect, organize, analyze, and share disease-state and competitor data
• Connect insights, data, and technology to support decision-making for GMA and Program Teams
• Deliver training to internal stakeholders and build DMD and siRNA competency within Sarepta
• Develop, update, and manage medical content and Medical/Legal/Regulatory review processes in Veeva
• Manage vendors and provide strategic scientific guidance
• Maintain approved medical materials and coordinate MLR review
• Participate in medical review of redacted or anonymized clinical trial documents
• Serve as medical lead or reviewer for congress materials
• Address inquiries from Field Medical teams and Medical Information
• Represent Global Medical Affairs on cross-functional teams
• Model integrity, compliance, and ethical conduct
• Perform additional related duties as required

Senior Manager, Global Medical Affairs Strategy, RNA Therapeutics

• Serve as Lead Study Statistician for assigned clinical studies from protocol development through database lock, data analysis, interpretation, and reporting
• Own statistical strategy and execution for assigned clinical trials
• Progressively assume responsibility as Program Statistical Lead across studies and development stages
• Partner with Clinical Development and senior leadership on key program decisions, pivotal study strategy, integrated analyses, and regulatory strategy
• Lead statistical design of clinical trials, including endpoint strategy, sample size, randomization, interim analyses, and methodological considerations
• Evaluate, implement, and interpret adaptive trial designs
• Provide statistical leadership and hands-on support for regulatory submissions, including pivotal analyses, submission documents, analysis datasets, and responses to regulatory inquiries
• Lead or contribute to statistical discussions with FDA, EMA, and other health authorities
• Collaborate with Clinical Development, Clinical Operations, Data Management, Medical, Regulatory, Statistical Programming, and other functions
• Provide statistical oversight and direction to CROs and external vendors
• Develop, review, troubleshoot, and validate statistical analyses, outputs, and documentation in R and/or SAS
• Provide technical oversight of statistical programming and analysis datasets
• Develop statistical standards, best practices, processes, and capabilities
• Mentor and develop statisticians and statistical programmers
• Contribute to hiring, resource planning, and team growth

Director, Biostatistics

• Provide leadership on GCP and GLP quality assurance support and guidance to clinical and non-clinical stakeholders
• Act as the primary Quality business partner to R&D functional leaders across Clinical, Non-Clinical, Research, and Pharmacovigilance areas
• Partner with teams to resolve compliance issues at vendors and investigator sites
• Assess the impact of deficiencies and recommend corrective actions
• Assist in developing and implementing CAPA plans and investigations in response to quality issues, audits, and inspections
• Review clinical trial documentation and regulatory submission materials for completeness and compliance
• Develop and maintain study-specific audit plans
• Support audit preparation, site selection, execution, and response coordination
• Contribute to implementation and continuous improvement of GxP-compliant procedures and operations
• Support inspection readiness activities and provide guidance during GxP inspections
• Perform related duties and special projects as assigned

Director, Corporate Quality – GCP

QA Engineer

• Maintain GxP quality systems processes and procedures to drive quality compliance and business efficiencies
• Work cross-functionally with quality assurance operations, quality control, manufacturing, validation, MS&T, and external vendors
• Gather, analyze, interpret, and report manufacturing and testing data for trending programs
• Address adverse trends and gaps through continuous improvement
• Track, manage, and complete cross-functional quality records including deviations, lab investigations, change controls, complaints, and CAPA
• Maintain quality metrics and KPIs for quality record trending
• Execute quarterly and annual quality record trending and escalate risks to the Quality Review Board
• Provide QA oversight for risk assessments and ensure regulatory-compliant quality risk management
• Support regulatory inspections, submissions, and internal/external audits
• Manage observation responses from inspections, submissions, and audits
• Own and manage the Product Recall process and execute the Annual Mock Recall
• Escalate quality defects to health authorities as applicable
• Serve as SME for Product Complaint Management and track commercial product complaints
• Participate in Joint Signal Detection meetings and generate complaint/change-control metrics
• Author, review, and approve GMP controlled documents, including quality manuals and compliance policies/procedures

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

Senior Manager, Global Medical Affairs Strategy, RNA Therapeutics

Director, Biostatistics

Director, Corporate Quality – GCP

Senior Manager, QA Compliance