Associate Director, Clinical Operations

Responsibilities

• Develop clinical operations strategy for programs in development
• Collaborate cross-functionally to develop protocols, safety reports, investigator brochures, and regulatory submissions
• Evaluate and select CROs and sites, developing scopes of work, contracts, and budgets
• Develop and manage SOPs and ensure GCP compliance
• Manage study timelines in coordination with clinical development, pharmacology, data management, and regulatory affairs
• Lead patient recruitment planning and forecasting
• Manage and mentor Clinical Operations team members

Requirements

• Minimum 8 years of experience in clinical operations across at least 2 therapeutic areas, including oncology
• Experience managing CROs and vendors for US and international clinical trials
• Experience in site initiation visits, site management, and data cuts for regulatory requirements
• Strong understanding of the drug development process from IND to NDA
• Ability to communicate effectively in a fast-paced, collaborative environment

Preferred Qualifications

• Experience in large Pharma and biotech
• Experience with biomarker-selected studies
• Previous experience managing direct reports

About the Company

Generate:Biomedicines is a clinical-stage generative biology company pioneering the AI revolution in drug design and development. They integrate machine learning with large-scale experimentation to design proteins with defined biological intent, aiming to reduce the uncertainty, time, and cost of developing protein-based medicines.