Associate Director, Clinical Operations Lead – Asthma
Generate Biomedicines
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $160,000 - $224,000 per year
Job Level
Senior
Tech Stack
Google Cloud Platform
About the role
- Serve as the operational lead for global Phase 3 asthma studies
- Develop overall study strategy, timelines, and operational plans
- Lead scenario planning, risk assessment, and proactive mitigation efforts
- Review and approve key trial documents
- Lead and coordinate multidisciplinary study teams
- Act as the central point of accountability across stakeholders
- Enable effective communication, decision-making, and timely issue escalation
- Oversee study start-up, site identification, enrollment strategy, monitoring plans
- Ensure study conduct follows ICH-GCP, SOPs, and global regulatory requirements
- Manage study budget, vendor performance, timelines, and quality metrics
- Assist in audit preparation and ensure corrective and preventive actions
- Partner closely with data management and biostatistics for data quality
- Drive inspection readiness and continuous study health assessments
- Provide operational oversight of CROs and ensure deliverables meet expectations
Requirements
- 8–12+ years of clinical operations experience
- At least 6 years of direct leadership in Late Phase global studies
- Late Phase Respiratory or immunology therapeutic area experience
- Strong leadership, strategic planning, communication, and problem-solving skills
- Ability to work independently while orchestrating complex cross-functional execution
- Pharmaceutical industry experience and working knowledge of ICH/GCP regulations
- Bachelor's degree required; advanced degree (MS, MPH, PharmD, PhD) preferred.
Benefits
- Competitive benefits package
- Annual bonus
- Equity compensation
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical operationsstudy strategy developmentrisk assessmentbudget managementvendor performance managementdata quality managementaudit preparationinspection readinessstudy monitoringenrollment strategy
Soft skills
leadershipstrategic planningcommunicationproblem-solvingindependent workcross-functional collaborationdecision-makingissue escalationteam coordinationstakeholder management
Certifications
Bachelor's degreeadvanced degree (MS, MPH, PharmD, PhD)