Sr. Program Manager
Core
Oversee and drive cross-functional development programs for small molecule therapeutics, ensuring execution on time, within budget, and in compliance with global regulatory standards.
Role type
Senior Program Manager (Drug Development)
Builds
Small molecule therapeutics from preclinical through late-stage clinical studies to NDA submission
Domain
Biopharmaceuticals / Small Molecule Drug Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Cross-functional team leadership, CMC process development, regulatory strategy, project lifecycle management, risk mitigation, budgeting and forecasting, stakeholder influence
Preferred skills
Biopharmaceutical launch experience, PMP certification, Design Controls knowledge, strategic product alignment
Technologies
GxP compliance frameworks, FDA/EMA/ICH guidelines
Responsibilities
Lead cross-functional teams through all stages of small molecule drug development; Drive end-to-end program lifecycle from initiation to closure; Oversee CMC timelines and deliverable completion; Coordinate with Nonclinical activities to enable regulatory submissions; Partner with Regulatory Affairs for NDA completion; Develop integrated project plans covering scope, timelines, budgets, and risks; Track progress against milestones and implement corrective actions; Provide updates to executive leadership and governance committees.
Seniority
Senior, hands-on IC
