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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expert knowledge of GCP and ICH regulations, along with advanced project management and program-wide decision-making skills. Proven ability to lead cross-functional teams in clinical development, ensuring operational excellence and compliance throughout the clinical research process.
Highest-signal resume keywords
Expert Knowledge Of GCP And ICH RegulationsAdvanced Project Management SkillsClinical Database Platforms ExperienceStrong Leadership And Talent Development SkillsExperience With AI-Enabled Approaches
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 DevelopmentProtocol DesignProgram PlanningRisk ManagementData Review ToolsEnrollment StrategiesQuality ControlRegulatory SubmissionsOperational OversightClinical Research Process
Soft Skills
Advanced Problem-SolvingCritical ThinkingVerbal CommunicationWritten CommunicationConflict Navigation
Tools & Technologies
Central Monitoring PlatformsRBQM PlatformsClinical Operations Project SchedulesQuality Metric DashboardsRAID Logs
Certifications & Qualifications
PMP Certification
Industry Keywords
Clinical TrialsPharmaceutical DevelopmentTherapeutic AreasPost-Marketing ApprovalStakeholder Engagement
Tech Stack
Tools & technologiesGoogle Cloud PlatformPMP
About the role
Key responsibilities & impact- Lead and direct global, cross-functional teams in end-to-end clinical development activities from strategic planning through post-marketing approval
- Provide strategic and operational leadership for highly complex clinical programs across disease areas and indications
- Lead program planning and execution, including program-level overviews and senior management and governance meetings
- Provide operational input during protocol design and program-level development planning
- Develop and maintain Clinical Operations Project Schedules and oversee trial-plan deliverables
- Provide program-level oversight of enrollment, site feasibility and selection, and patient and site engagement strategies
- Conduct resource planning and staffing, including hiring, onboarding, and management of Trial Managers and other Program Leads
- Oversee program-level execution, milestones, metrics, delays, risks, feasibility, efficiency, and quality
- Serve as the primary escalation point for operational issues and resolve cross-functional issues
- Partner with Portfolio Sourcing & Relationship Management on service-provider strategy, contracting, and oversight
- Review regulatory submissions, Health Authority responses, meeting materials, Risk Language, and Clinical Study Reports
- Identify and minimize operational risks using RAID logs, Quality Plans, and quality metric dashboards
- Collaborate on program-level RACT and review and approve Program Quality Plans
- Review protocol-level CTQ factors and key trial plans for consistency and quality control
- Own inspection readiness, post-inspection responses, CAPA/SQI management, and collaboration with Clinical Quality Operations
- Represent operations on the Product Development Clinical Subteam and escalate risks, quality issues, and timeline/cost challenges
- Collaborate with internal and external stakeholders, including KOLs and vendors
- Lead process-improvement, strategic, digital-transformation, and AI-fluency initiatives
- Potentially lead operational components of mergers and acquisitions
- Train, upskill, supervise, and manage the development and performance of direct and indirect reports
- Support CTT onboarding and Trial Manager-specific training
Requirements
What you’ll need- Expert knowledge of GCP and ICH regulations
- Expert understanding of the end-to-end clinical research process, therapeutic areas, and competitive landscape
- Experience driving adoption of scalable digital and AI-enabled approaches, including reviewing AI output and understanding limitations and constraints
- Advanced knowledge of clinical database platforms, central monitoring/RBQM platforms, and data review tools
- Advanced delegation, project-management, and program-wide decision-making skills
- Ability to navigate high-stakes conflicts with internal and external stakeholders
- Advanced problem-solving, critical-thinking, and scenario-planning skills
- Advanced verbal and written communication skills
- Strong leadership, coaching, mentoring, and talent-development skills
- Bachelor’s degree plus 15 years of experience, or Master’s degree plus 12 years, or PhD/PharmD plus a minimum of 8 years of pharmaceutical and/or clinical drug development experience
- Degree in life sciences preferred
- PMP certification preferred
- Experience conducting pragmatic studies preferred
- Must be a US or Puerto Rico resident
- No visa sponsorship available
- 10% travel required
Benefits
Comp & perks- Annual bonus
- Long-term incentive, if applicable
- Medical, dental, and vision healthcare
- Other insurance benefits for employee and family
- Retirement benefits, including 401(k)
- Paid holidays
- Vacation
- Compassionate and sick days
- Hybrid work arrangement