Director, Clinical Operations Lead - COPD

Generate Biomedicines•Somerville, MA

15h•$186,000 - $279,000

About The Position

As we expand our late-stage development organization, we are seeking a Director, Clinical Operations– COPD to provide strategic and operational leadership for global Phase 3 development. This role will serve as the operational leader across one or more complex, late-stage COPD studies, with full accountability for study strategy, execution, quality, budget, and delivery. In addition to program leadership, this role includes direct line management of Clinical Operations professionals, with responsibility for hiring, developing, coaching, and building high-performing teams. The Director will play a key role in shaping operational strategy, advancing functional excellence, and strengthening Generate’s late-stage development capabilities. Here's how you will contribute: Program Leadership Provide strategic oversight and end-to-end operational leadership for global Phase 3COPDstudies and related development activities. Translate program strategy into comprehensive, executable operational plans aligned with regulatory, scientific, and corporateobjectives. Accountable for 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 to inform portfolio-level planning and decision-making. People Leadership & Organizational Development Directly manage and develop Clinical Operations staff (e.g., Clinical Trial Leads and/or Clinical Trial Managers). Recruit, hire, onboard, and retain top talent to support late-stage clinical development. Set performance expectations, conduct evaluations, provide coaching, and support career development. Build a culture of accountability, collaboration, and operational excellence. Cross-Functional Collaboration Lead multidisciplinary study teams across Clinical Operations, Data Management, Biostatistics, Safety, Regulatory, Medical, Quality, and CMC. Act as a primary point of accountability across internal stakeholders, CRO partners, and external vendors. Enable effective decision-making, timely escalation, and transparent communication across teams. Operational Excellence & Risk Management 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. Provide oversight of 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 proactive issue identification, risk management, and CAPA oversight. Functional Leadership & Process Improvement 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 help define standards across the clinical operations organization.

Requirements

12–15+ years of clinical operations experience within the pharmaceutical or biotechnology industry.
Bachelor’s degree required; advanced degree (MS, MPH, PharmD, PhD)is strongly preferred.
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 thinker with strong operational execution skills.
Deep working knowledge of ICH/GCP and global clinical development regulations.

Nice To Haves

Late-phase respiratory or immunology therapeutic area experience.
Experience building or scaling clinical development functions in a high-growth organization.

Responsibilities

Provide strategic oversight and end-to-end operational leadership for global Phase 3COPDstudies and related development activities.
Translate program strategy into comprehensive, executable operational plans aligned with regulatory, scientific, and corporateobjectives.
Accountable for 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 to inform portfolio-level planning and decision-making.
Directly manage and develop Clinical Operations staff (e.g., Clinical Trial Leads and/or Clinical Trial Managers).
Recruit, hire, onboard, and retain top talent to support late-stage clinical development.
Set performance expectations, conduct evaluations, provide coaching, and support career development.
Build a culture of accountability, collaboration, and operational excellence.
Lead multidisciplinary study teams across Clinical Operations, Data Management, Biostatistics, Safety, Regulatory, Medical, Quality, and CMC.
Act as a primary point of accountability across internal stakeholders, CRO partners, and external vendors.
Enable effective decision-making, timely escalation, and transparent communication across teams.
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.
Provide oversight of 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 proactive 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 help define standards across the clinical operations organization.