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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive experience in leading global clinical operations, including trial management, regulatory compliance, and vendor governance. Proven ability to drive performance, mentor leadership teams, and implement strategic resource planning in a biopharmaceutical environment.
Highest-signal resume keywords
Clinical Operations LeadershipGlobal Clinical Trials ManagementRegulatory Compliance (ICH-GCP, FDA/EMA)CRO/Vendor GovernanceOncology Clinical Research
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trial ManagementData Management SystemsSample LogisticsSite MonitoringPhase III Trial ExecutionRegulatory Filing PreparationOperational Metrics ImplementationBudget PlanningResource Capacity PlanningBusiness Process Optimization
Soft Skills
Strong Communication SkillsInfluencing SkillsMentoringTeam LeadershipChange Management
Tools & Technologies
CTMSETMFDecentralized Trial Technologies
Industry Keywords
BiotechPharmaceuticalCROOncologyCell TherapyImmuno-OncologyClinical ResearchGlobal SOPsTalent AcquisitionWorkforce Planning
About the role
Key responsibilities & impact- Serve as operational deputy and strategic partner to the VP, Clinical Operations
- Lead day-to-day operations of the global Clinical Operations organization and act as primary delegate and decision-maker within established authority matrices
- Align Trial/Asset Operations, Site Operations, Biosample Operations, and Clinical Systems into one unified ecosystem
- Align sub-functions with corporate development milestones and portfolio timelines
- Maintain holistic visibility across the clinical portfolio and manage dependencies, critical paths, and resource constraints
- Establish early-warning frameworks to identify, escalate, and mitigate execution issues, protocol deviations, and trial bottlenecks
- Mentor clinical operations leads and asset directors while ensuring accountability
- Lead and develop the senior clinical operations leadership team; design succession plans and career pathways
- Cultivate a unified culture across US and Germany organizational footprints
- Drive performance calibration, talent acquisition, workforce planning, and organizational capability mapping
- Own portfolio capacity planning, headcount forecasting, and strategic resource deployment
- Oversee budget planning, accrual tracking, and financial forecasting
- Manage CRO/vendor selection, performance metrics, and governance frameworks
- Analyze and recommend insourcing versus outsourcing strategies
- Champion continuous improvement, business process optimization, and scalable clinical workflows
- Ensure adherence to ICH-GCP, FDA/EMA regulations, and global SOPs
- Lead inspection readiness frameworks, internal quality audits, and harmonized global data standards
- Implement predictive operational metrics, KPIs, and executive dashboards
- Co-architect and execute the future-state operating model for late-stage development and commercialization
- Lead enterprise-wide change management, capability integration, and digital/systems evolution, including CTMS, eTMF, and decentralized trial technologies
- Design and deploy repeatable organizational systems to eliminate recurring operational friction points
Requirements
What you’ll need- Bachelor’s degree in a scientific, nursing, or business discipline required
- 15+ years of clinical research experience within a biotech, pharmaceutical, or major CRO environment
- 7+ years in a senior, multi-functional leadership capacity
- Advanced degree (MD, PhD, PharmD, MS, or MBA) preferred
- Direct operational experience managing Cell Therapy, Immuno-Oncology, or advanced therapeutic modality trials is a strong plus
- Experience leading multiple dimensions of clinical operations, including trial management, data/systems, sample logistics, and site monitoring
- Extensive experience leading complex, global clinical trials across North America and Europe
- Deep experience navigating clinical operations in Oncology required
- Proven experience driving Phase III registrational trials, global regulatory filings, and preparing operations for commercialization
- Experience leading Clinical Operations within a biopharmaceutical organization with strong understanding of internal clinical operations, trial execution, and regulatory requirements
- Sophisticated experience managing large-scale CRO partnerships and vendor governance committees
- Strong communication and influencing skills
- Applicants must be authorized to work in the United States without the need for current or future sponsorship
- Successful completion of a background check, reference checks, and pre-employment drug screening, where permitted by applicable law
Benefits
Comp & perks- Competitive rates for Health, Dental, and Vision Insurance
- PTO accrued bi-weekly, with up to 80 hours available to borrow and a maximum accrued balance of 240 hours
- 12 company paid holidays
- 10 days of sick time
- 100% employer-paid life insurance up to 1x annual salary, up to one hundred thousand dollars
- 100% employer-paid short- and long-term disability coverage
- 401(k) with immediate eligibility and company match
- Partially paid parental leave for eligible employees
- Voluntary employee-paid benefits and services, including accident, hospital indemnity, and critical illness insurance, identity theft protection, and pet insurance
