Generate Biomedicines

Pioneering generative biology to create breakthrough therapeutics.

Director, Clinical Operations – Severe Asthma

Full TimeRemoteTeam 201-500Since 2020H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

16 days ago

Salary

$186K - $279K / year

Bachelor Degree12 yrs expEnglishGoogle Cloud Platform

Job Description

• 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.

Job Requirements

  • 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

Benefits

  • Competitive benefits package
  • Annual bonus
  • Equity compensation

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