Senior Global Oncology Clinical Program Lead

Menarini Group; United States; On-site; USD 220,000 - 270,000; Full time

Job summary

Menarini Stemline, a leading oncology-focused biopharma, seeks a Global Clinical Program Lead to head cross-functional clinical operations for assigned programs. You will drive study execution, budget alignment, and vendor coordination to ensure on-time enrollment and milestones.

You will partner with CROs and internal teams, optimize trial designs and metrics, and mentor the clinical Operations group. This corporate office role emphasizes strategic oversight and regulatory compliance.

Qualifications

• BS/BA degree in a scientific or health related discipline. Advanced scientific or equivalent experience preferred.
• Experience leading teams in APAC region.
• Minimum of 15 years of experience in drug development, clinical research and operational strategy in biotech/pharma.
• Oncology experience is required.
• Demonstrated project/program management skills including risk assessment, timeline and budget management.
• Line management experience including talent identification, development, coaching, performance management and resource allocation.
• Effective team leadership of matrix teams.
• Experience across several complex therapeutic areas.
• Experience planning and delivering US based and global clinical programs and studies.
• Multi-study experience managing early through late-stage clinical trials.
• Working knowledge of clinical trial conduct, GCPs and FDA Regulations.

Responsibilities

• Leads multiple clinical studies in parallel, through direct reports and/or vendors.
• Leads all aspects of study execution, with or without a CRO, including operational plans and timelines to achieve on-time enrollment and study completion.
• Promotes effective partnership among cross-functional teams and provide day to day direction for core team. Leads problem solving and resolution efforts.
• Strategically supports in protocol finalization, optimizing trial design and execution with regular reporting of study performance metrics.
• Develops and coordinates operational plans for one or multiple studies within a development program.
• Shapes the regional Clinical Operation team(s) including in-house and CROs to ensure quality, timeliness and budget adherence.
• Responsible for managing performance and career development of direct and indirect reports.
• Drives clinical trial database construction, data collection, and assists with audits of data to ensure data integrity.
• Manages CRO and site budgets, communicates deviations from budget projections, and proposes solutions for deviations.
• Influences recruitment strategies with evaluation of enrollment against targets and working with sites to meet or exceed targets.
• Accountable for Clinical Operations budgeting and forecasting and monitoring against actuals.
• Ensures regulatory compliance with SOPs, GCP, FDA and international regulations.
• Meets with team members regularly to ensure milestones are met.
• Serves as primary escalation contact with vendors and leads proposal development and bid-defense.

Skills

Cross-functional leadership

Clinical operations

Budget management

Regulatory knowledge

Communication skills

Education

BS/BA in scientific discipline

Advanced scientific experience

Job description

Menarini Stemline, a leading oncology-focused biopharma, seeks a Global Clinical Program Lead to head cross-functional clinical operations for assigned programs. You will drive study execution, budget alignment, and vendor coordination to ensure on-time enrollment and milestones.

You will partner with CROs and internal teams, optimize trial designs and metrics, and mentor the clinical Operations group. This corporate office role emphasizes strategic oversight and regulatory compliance.