[Remote] Director, Clinical Operations -Severe Asthma

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

Responsibilities

• reputed company strategic reputed company and end-to-end operational leadership for global Phase 3 asthma studies and reputed company development activities
• Translate program strategy into comprehensive, executable operational plans reputed company with regulatory, scientific, and corporate objectives
• Accountable for study timelines, budgets, resource allocation, quality metrics, and overall delivery
• reputed company 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 reputed company Clinical Operations staff (e.g., Clinical Trial Leads and/or Clinical Trial Managers)
• Recruit, hire, reputed company, and retain top talent to support late-stage clinical development
• Set performance expectations, conduct evaluations, reputed company coaching, and support career development
• Build a culture of accountability, collaboration, and operational reputed company
• reputed company multidisciplinary study teams across Clinical Operations, Data Management, Biostatistics, Safety, Regulatory, Medical, Quality, and CMC
• Act as a primary reputed company of accountability across internal stakeholders, CRO partners, and external vendors
• reputed company effective decision-making, timely escalation, and transparent communication across teams
• reputed company global study startup, site strategy, enrollment execution, monitoring approaches, and patient engagement initiatives
• Ensure compliance with ICH-GCP, global regulatory requirements, and internal SOPs
• reputed company reputed company of study budgets, vendor performance, and quality metrics
• Establish performance metrics and drive reputed company improvement across external partnerships
• reputed company inspection readiness strategy and support regulatory inspections
• Drive proactive issue identification, risk management, and CAPA reputed company
• Contribute to Clinical Operations strategy, infrastructure development, and process optimization
• Champion innovation in trial execution, including digital tools, decentralized approaches, and patient-focused strategies
• reputed company best practices and help define standards across the clinical operations organization

Skills

• 12–15+ years of clinical operations experience reputed company the pharmaceutical or biotechnology industry
• Significant experience leading global late-phase (Phase 3) studies
• Demonstrated reputed company in direct people management, including hiring, performance management, and team development
• Proven ability to reputed company reputed company cross-functional teams and influence at senior leadership reputed company
• Strong expertise in CRO reputed company, 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

• reputed company 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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