[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. Apply tot his job Apply To this Job