Associate Director, Clinical Operations Lead – Asthma

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Generate Biomedicines

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Biotechnology • Artificial Intelligence • Pharmaceuticals

Generate Biomedicines is a pioneering therapeutics company that stands at the intersection of machine learning, biological engineering, and medicine. They are leading the development of generative biology, a groundbreaking approach that uses artificial intelligence to create novel medicines with specific therapeutic functions. By studying millions of proteins, Generate Biomedicines has discovered generalizable rules by which nature encodes function, enabling them to generate medicines on demand across multiple therapeutic modalities. Their innovative platform promises to fundamentally change the way medicines are made, expanding technical possibilities and improving speed and success rates in drug discovery.

201 - 500 employees

Founded 2020

🧬 Biotechnology

🤖 Artificial Intelligence

💊 Pharmaceuticals

💰 $370M Series B on 2021-11

📋 Description

• 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