Director, Clinical Operations

Generate Biomedicines

. Provide strategic oversight and end-to-end operational leadership for global Phase 3 studies and related development activities .

Posted 9/18/2026full-timeRemote • United StatesLead💰 $186,000 - $279,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in leading global Phase 3 clinical studies, with a strong focus on operational execution, regulatory compliance, and team development. Proven ability to manage complex cross-functional teams and drive strategic initiatives within the pharmaceutical or biotechnology industry.

Highest-signal resume keywords

Clinical Operations LeadershipGlobal Phase 3 Study ManagementCRO OversightICH/GCP ComplianceStrategic Planning

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical OperationsRegulatory ComplianceBudget ManagementRisk ManagementPerformance MetricsScenario PlanningQuality MetricsTalent DevelopmentProcess OptimizationInspection Readiness

Soft Skills

Team DevelopmentStrategic ThinkingInfluencing SkillsCoachingCollaboration

Tools & Technologies

Digital ToolsDecentralized Approaches

Industry Keywords

Pharmaceutical IndustryBiotechnology IndustryGlobal Regulatory RequirementsClinical Development RegulationsCAPA Oversight

About the role

Key responsibilities & impact

Provide strategic oversight and end-to-end operational leadership for global Phase 3 studies and related development activities
Translate program strategy into comprehensive, executable operational plans aligned with regulatory, scientific, and corporate objectives
Own study timelines, budgets, resource allocation, quality metrics, and overall delivery
Lead scenario planning, risk forecasting, and mitigation strategies at the program level
Partner with Clinical Development leadership on portfolio-level planning and decision-making
Directly manage and develop Clinical Operations staff
Recruit, hire, onboard, and retain talent
Set performance expectations, conduct evaluations, provide coaching, and support career development
Lead multidisciplinary study teams across Clinical Operations, Data Management, Biostatistics, Safety, Regulatory, Medical, Quality, and CMC
Coordinate internal stakeholders, CRO partners, and external vendors
Oversee global study startup, site strategy, enrollment execution, monitoring approaches, and patient engagement initiatives
Ensure compliance with ICH-GCP, global regulatory requirements, and internal SOPs
Oversee study budgets, vendor performance, and quality metrics
Establish performance metrics and drive continuous improvement across external partnerships
Lead inspection readiness strategy and support regulatory inspections
Drive issue identification, risk management, and CAPA oversight
Contribute to Clinical Operations strategy, infrastructure development, and process optimization
Champion innovation in trial execution, including digital tools, decentralized approaches, and patient-focused strategies
Share best practices and define standards across the clinical operations organization

Requirements

What you’ll need

12–15+ years of clinical operations experience within the pharmaceutical or biotechnology industry
Bachelor’s degree required
Significant experience leading global late-phase (Phase 3) studies
Demonstrated success in direct people management, including hiring, performance management, and team development
Proven ability to lead complex cross-functional teams and influence at senior leadership levels
Strong expertise in CRO oversight, global regulatory environments, and inspection readiness
Strategic thinking and strong operational execution skills
Deep working knowledge of ICH/GCP and global clinical development regulations

Benefits

Comp & perks

Annual bonus
Equity compensation
Competitive benefits package