Global Study Lead

Scorpion Therapeutics; Philadelphia (Philadelphia County); On-site; USD 170,000 - 210,000; Full time

Job summary

Scorpion Therapeutics is seeking a Global Study Lead (Sr. Manager, Clinical Operations) to plan and execute global clinical trials from start-up through closeout. You will lead cross-functional teams to ensure on-time, on-budget delivery in compliance with GCP and company procedures.

The role requires 7+ years in clinical research, 3-5 years leading global trials, and experience with CROs. Strong leadership, financial, and communication skills are essential; travel ~10% is expected.

Qualifications

• BS/BA required.
• 7+ years clinical research experience (CRO/biotech/pharma) on Phase 1-4 global trials.
• 3-5 years leading end-to-end global clinical trials; Phase 3 registrational trials experience.
• Experience managing global trials outsourced to a CRO.
• Strong decision-making, analytical, financial, leadership, organizational, planning, communication, and problem-solving skills.
• Demonstrated success leading cross-functional teams in global matrix organizations; results through influence.
• Experience mentoring/coaching others.
• Proficient with MS Office (Excel, Word, PowerPoint) and MS Project.

Responsibilities

• Lead cross-functional trial teams to develop and execute study operational plans; ensure end-to-end delivery.
• Accountable for trial-level delivery: timelines, budget management, quality oversight, key milestones, and deliverables.
• Oversee CRO/vendor selection, onboarding, contracting, performance monitoring, budgeting, and issue resolution.
• Identify and mitigate operational risks; ensure deliverables meet goals.
• Ensure trial operations comply with global regulations and internal procedures.
• Support Health Authority Inspections and internal QA audits; maintain inspection-readiness.
• Drive continuous improvement in execution, efficiency, quality, and cross-functional collaboration.
• Mentor and support onboarding/development of Study Management colleagues.
• Partner with Finance, Program Management, Quality, Regulatory, Clinical Research, Data/Statistics, Safety, Supply, etc.
• Provide budget variance analysis and notify Finance of projected cost overruns/underruns.
• Provide operational updates, risks, and recommendations to governance/leadership forums.
• Travel ~10% (flexible as needed).

Education

BS/BA

Tools

MS Office

MS Project

Job description

The Global Study Lead (Sr. Manager, Clinical Operations)

The Global Study Lead (Sr. Manager, Clinical Operations) leads operational planning and execution of global clinical trials from study start-up through closeout, providing cross-functional leadership to ensure objectives are achieved on time, within budget, and in compliance with applicable regulations, Good Clinical Practice (GCP), and company procedures.

Responsibilities:

• Lead cross-functional trial teams to develop and execute study operational plans; ensure end-to-end delivery.


• Accountable for trial-level delivery: timelines, budget management, quality oversight, key milestones, and critical deliverables.


• Oversee CRO/vendor selection, onboarding, contracting, performance monitoring, budgeting, and issue resolution.


• Proactively identify and mitigate operational risks; ensure deliverables/milestones meet corporate and study goals.


• Ensure trial operations are compliant with global health authority regulations and internal operating procedures.


• Support Health Authority Inspections and internal QA audits; maintain inspection-readiness with R&D Quality.


• Drive continuous improvement in execution, efficiency, quality, and cross-functional collaboration.


• Mentor and support onboarding/development of Study Management colleagues.


• Partner with internal stakeholders (e.g., Finance, Program Management, Quality, Regulatory, Clinical Research, Data/Statistics, Safety, Supply, etc.).


• Provide budget variance analysis and notify Finance of projected cost over/under.


• Provide operational updates, risks, and recommendations to governance/leadership forums.


• Travel ~10% (flexible as needed).

Qualifications:

• BS/BA required.


• 7+ years clinical research experience (CRO/biotech/pharma) on Phase 1-4 global trials.


• 3-5 years leading end-to-end global clinical trials; experience with Phase 3 registrational trials.


• Experience managing global trials outsourced to a CRO.


• Strong decision-making, analytical, financial, leadership, organizational, planning, communication, and problem-solving skills.


• Demonstrated success leading cross-functional teams in global matrix organizations; results through influence.


• Experience mentoring/coaching others.


• Proficient with MS Office (Excel, Word, PowerPoint) and MS Project.