Global Clinical Program Lead

TCWGlobal; San Diego (CA); Presencial; USD 150 000 - 190 000; Tempo integral

Resumo da oferta

TCWGlobal is seeking an experienced Senior Clinical Program Manager to lead the planning, coordination, and execution of global clinical development programs within a biotechnology/pharmaceutical environment.

This role partners with Clinical Development leadership to drive clinical program strategy, manage integrated development plans, timelines, budgets, identify risks, and ensure milestones are delivered on schedule across both early- and late-stage programs, including IND/CTA and NDA/MAA

Qualificações

• Extensive clinical development and program management experience in pharma/biotech.
• Experience leading global clinical development programs across early- and late-stage drug development.
• Knowledge of regulatory milestones (IND/CTA, NDA/MAA).
• Understanding of drug development lifecycle and cross-functional dependencies.
• Ability to drive program objectives, influence stakeholders, and facilitate decisions.
• Strong project management skills and PM methodologies.

Responsabilidades

• Lead planning and execution of global clinical development programs with aligned timelines and budgets.
• Develop and maintain integrated Clinical Development Plans and milestones.
• Partner with Clinical Operations to manage objectives, work plans, budgets, timelines, and deliverables.
• Identify risks and develop mitigation and contingency plans.
• Lead site activation and enrollment planning to ensure timely study execution.
• Coordinate across Clinical Operations, Regulatory, Biostatistics, Data Management, and Manufacturing.
• Manage external partners and vendors to meet contractual obligations.
• Facilitate program meetings and communicate progress to leadership.
• Support IND/CTA and NDA/MAA submission milestones across programs.
• Identify opportunities to improve program management processes and tools.

Conhecimentos

Clinical program mgmt

Global programs

IND/CTA submissions

NDA/MAA submissions

Lifecycle management

Stakeholder management

Smartsheet

PM methodologies

Formação académica

Bachelor’s degree in Life Sciences

Master’s degree in Life Sciences

PhD in Life Sciences

Ferramentas

Smartsheet

Descrição da oferta de emprego

TCWGlobal is seeking an experienced Senior Clinical Program Manager to lead the planning, coordination, and execution of global clinical development programs within a biotechnology/pharmaceutical environment.

This role partners with Clinical Development leadership to drive clinical program strategy, manage integrated development plans, timelines, budgets, identify risks, and ensure milestones are delivered on schedule across both early- and late-stage programs, including IND/CTA and NDA/MAA