Global Biosimilars Study Management Leader

Planet Pharma; California; Híbrido; USD 77.000 - 91.000; Jornada completa

Descripción de la vacante

Planet Pharma in California is seeking an experienced clinical operations lead for global biosimilar trials conducted in collaboration with CROs. You will guide study design to close-out, manage timelines, budgets, and cross-functional deliverables to ensure high quality results.

The role demands strong CRO oversight, leadership of cross-functional teams, and meticulous TMF/inspection readiness to support regulatory milestones. Competitive hourly pay and global exposure are offered.

Formación

• Bachelor’s degree with 5 years of directly related experience.
• Master’s degree with 3 years of directly related experience.
• Doctorate degree with 2 years of directly related experience.
• Experience overseeing CROs.
• Experience leading cross-functional teams.

Responsabilidades

• Lead and coordinate global biosimilar trial execution in partnership with CROs.
• Oversee trial timelines, budgets and operational issues for biosimilar programs.
• Review and contribute to study documents including protocols and CSR.
• Provide cross-functional leadership and ensure timely, on-budget delivery.
• Organize investigator meetings and training with CRO partners.
• Ensure inspection readiness and quality through TMF reviews.
• Communicate program status to senior management.

Conocimientos

CRO oversight

Cross-functional leadership

Educación

Bachelor's degree

Master's degree

Doctorate degree

Descripción del empleo

Planet Pharma in California is seeking an experienced clinical operations lead for global biosimilar trials conducted in collaboration with CROs. You will guide study design to close-out, manage timelines, budgets, and cross-functional deliverables to ensure high quality results.

The role demands strong CRO oversight, leadership of cross-functional teams, and meticulous TMF/inspection readiness to support regulatory milestones. Competitive hourly pay and global exposure are offered.