[Remote] Director, Clinical Operations -Severe Asthma

Note: The job is a remote job and is open to candidates in USA. Generate:Biomedicines is a pioneering therapeutics company at the intersection of machine learning, biological engineering, and medicine. The Director of Clinical Operations for Severe Asthma will provide strategic and operational leadership for global Phase 3 development, overseeing study strategy, execution, and team management.

Responsibilities

• Provide strategic oversight and end-to-end operational leadership for global Phase 3 asthma studies and related development activities
• Translate program strategy into comprehensive, executable operational plans aligned with regulatory, scientific, and corporate objectives
• 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

Skills

• 12–15+ years of clinical operations experience within the pharmaceutical or biotechnology industry
• 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
• Bachelor's degree required
• Advanced degree (MS, MPH, PharmD, PhD) strongly preferred
• Late-phase respiratory or immunology therapeutic area experience
• Experience building or scaling clinical development functions in a high-growth organization

Benefits

• Annual bonus
• Equity compensation
• Competitive benefits package

Company Overview

• Pioneering generative biology to create breakthrough therapeutics. It was founded in 2018, and is headquartered in Somerville, Massachusetts, USA, with a workforce of 201-500 employees. Its website is https://generatebiomedicines.com.

Company H1B Sponsorship

• Generate:Biomedicines has a track record of offering H1B sponsorships, with 7 in 2025, 12 in 2024, 9 in 2023, 3 in 2022, 2 in 2021, 1 in 2020. Please note that this does not guarantee sponsorship for this specific role.

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