Senior Director, Program Lead - Infectious Diseases
Core
Strategic and operational leadership for complex, global infectious disease clinical development programs from planning through post-marketing approval.
Role type
Senior Director, Program Lead (Clinical Operations)
Builds
End-to-end clinical development programs for infectious disease assets
Domain
Biopharmaceuticals / Infectious Diseases
Required skills
GCP/ICH regulations, end-to-end clinical research process, strategic digital/AI adoption, clinical database platforms, central monitoring/RBQM, project management, program-wide decision-making, problem solving, critical thinking, scenario planning, operational leadership, regulatory submissions, scientific writing, therapeutic knowledge
Preferred skills
Life sciences degree, PMP certification, pragmatic studies experience
Technologies
Clinical database platforms, central monitoring/RBQM platforms, data review tools, AI-enabled approaches
Responsibilities
Lead and direct global cross-functional teams in end-to-end clinical development; provide operational input on protocol design and development planning; develop and maintain clinical operations project schedules; oversee trial-level enrollment, site feasibility, and patient engagement strategies; conduct resource planning and staffing across programs; hold overarching responsibility for program execution and risk management; partner on service provider strategy; review regulatory submissions and quality plans; own inspection readiness; serve as operational representative on clinical subteams; lead process improvement and digital transformation initiatives; manage mergers and acquisitions operational components; train and supervise direct and indirect reports.
Seniority
Senior Director, strategic & operational leadership