Global Study Leader

Scorpion Therapeutics; California (MD); On-site; USD 150,000 - 230,000; Full time

Job summary

Scorpion Therapeutics seeks a senior clinical operations leader to oversee global Phase I–IV trials, ensuring operational excellence and cross-functional alignment. You will mentor teams, manage TMF and CTMS, and coordinate with vendors, sites, and investigators to deliver trials on time and within budget.

The role requires 7+ years in clinical research with leadership experience and deep knowledge of ICH-GCP, SOPs, and regulatory processes. Travel 10–20% is expected.

Qualifications

• 7+ years in clinical research with leadership experience.
• Experience managing global Phase I–IV trials and programs.
• Strong knowledge of ICH-GCP, regulatory start-up planning, and SOP adherence.

Responsibilities

• Provide oversight with study team and service providers to ensure study delivery and operational excellence.
• Delegate tasks to study team members.
• Lead implementation, execution, and management of global Phase I–IV clinical trials.
• Lead/facilitate trial-related meetings and ensure cross-functional alignment.
• Escalate cross-functional issues for timely resolution and alignment.
• Participate in program-level discussions with updates to senior management.
• Develop and execute clinical trial strategies; track progress, risks, and mitigations.
• Own TMF; act as SME for Clinical Operations sections.
• Develop/review trial plans and essential clinical trial documents; review protocols and SBARs per SOPs.
• Oversee study execution including feasibility, planning, vendor selection, recruitment, and budgeting.
• Plan and support Investigator Meetings.
• Identify/manage risks and contingencies for timelines, quality, and compliance.
• Develop/track trial timelines and budgets; monitor vendor spend.
• Oversee external providers; ensure quality and compliance.
• Ensure accurate trial tracking and timely CTMS updates; oversee archiving.
• Serve as trial lead/SME during audits/inspections.
• Coordinate IMP shipment authorization.
• Assist data query process; review monitoring visit reports.
• Lead/participate in Clinical Operations initiatives; SME for process design.

Skills

Leadership

Cross-functional leadership

Stakeholder management

GCP knowledge

CTLMS/ TMF familiarity

Education

Bachelor’s degree in life sciences/healthcare or related

Advanced degree preferred

Tools

TMF systems

CTMS

Microsoft Office

Job description

Essential Functions/Responsibilities:

• Provide oversight with the study team and internal/external service providers to ensure study delivery and operational excellence.
• Delegate tasks to study team members.
• Lead implementation, execution, and management of global Phase I–IV clinical trials.
• Lead/facilitate trial-related meetings and ensure cross-functional alignment.
• Escalate cross-functional issues for timely resolution and alignment.
• Participate in program-level discussions (FMT/GPT) with updates to senior management.
• Develop and execute clinical trial strategies; track/report progress, risks, and mitigations to senior leadership.
• Own overall accountability for the Trial Master File (TMF); act as SME for Clinical Operations sections.
• Develop/review trial plans and essential clinical trial documents; review/approve protocols, informed consent forms, monitoring plans, and CSRs per SOPs.
• Oversee study execution including feasibility, planning, vendor selection, patient recruitment, and financial forecasting.
• Plan and support Investigator Meetings.
• Identify/manage risks and contingencies for timelines, quality, and compliance.
• Develop/track trial timelines and budgets; estimate/track/analyze vendor financial spend.
• Oversee external service providers/vendors; ensure quality, compliance, and performance.
• Ensure accurate trial tracking and timely CTMS updates; oversee documentation archiving.
• Serve as trial lead/SME during audits/inspections.
• Coordinate Investigational Medicinal Product (IMP) shipment authorization.
• Assist data query process; review monitoring visit reports (as required).
• Lead/participate in Clinical Operations/GCDO initiatives; serve as SME for process design/review.
• Ensure GCP/SOP compliance and adherence to agreed timelines/protocol.
• Mentor/coaching Global Study Managers, CRAs, and GSAs; lead CTWGs; resolve complex issues; manage high-performing teams.
• Travel: 10%–20%.

Required Knowledge, Skills, and Abilities:

• 7+ years clinical research experience; 3+ years in clinical operations leadership; global trial management/portfolio oversight.
• Strong organizational, time-management, attention to detail.
• Excellent written/verbal communication and stakeholder management.
• Ability to work independently and collaboratively in a fast-paced environment.
• Proficiency in Microsoft Office (Word, Excel, Outlook, PowerPoint).
• Clinical trial electronic systems knowledge (TMF, CTMS, etc.).
• Strong knowledge of clinical trial processes, ICH-GCP, regulatory requirements, and regulatory start-up planning (SSU).
• Proven cross-functional and global, multi-center trial project management.
• Leadership/governance experience with ability to influence senior levels.
• Travel: 10%–20%.

Education/Licenses:

• Bachelor’s degree (life sciences/healthcare or related) or equivalent experience.
• Advanced degree preferred.