Associate Director, Clinical Operations

Summary

Join Generate:Biomedicines, a leading therapeutics company, as an Associate Director, Clinical Operations. Lead the planning and execution of early-to-late-stage clinical trials, serving as the operational lead on high-priority studies. Collaborate with cross-functional teams, including Clinical Development, Regulatory Affairs, and Biometrics. Ensure trials are delivered on time and within budget, adhering to regulatory and GCP standards. Mentor junior team members and contribute to department-level initiatives. This role requires a Bachelor’s degree in a scientific or healthcare-related field, 8+ years of clinical trial operations experience (including 3+ years of independent study management), and a thorough understanding of GCP/ICH guidelines. The ideal candidate will have experience leading global clinical studies and managing CROs, labs, and vendors. Generate:Biomedicines offers a competitive salary, annual bonus, equity compensation, and a comprehensive benefits package.

Requirements

• Bachelor’s degree in a scientific or healthcare-related field; advanced degree preferred
• 8+ years of experience in clinical trial operations, including 3+ years of independent study management
• Proven ability to lead global clinical studies and manage CROs, labs, and vendors
• Thorough understanding of GCP/ICH guidelines and global regulatory requirements
• Strong project management, problem-solving, and negotiation skills
• Excellent communication and collaboration abilities across diverse stakeholder groups
• Prior experience mentoring, managing or directly supervising clinical operations talent
• Bachelor’s degree required; life sciences or related field preferred

Responsibilities

• Lead end-to-end execution of clinical studies, including vendor oversight, budget and timeline management, and quality assurance
• Act as the primary operational point of contact for assigned studies, ensuring cross-functional alignment and execution
• Oversee CRO selection, contract negotiation, and performance management; lead bid defense and vendor governance meetings
• Drive site identification, qualification, initiation, and ongoing engagement activities in partnership with CRO and clinical sites
• Review and contribute to protocol development, CRFs, study manuals, ICFs, and other key study documents
• Ensure high-quality data collection and timely resolution of study issues including safety, protocol deviations, and compliance
• Maintain inspection-ready Trial Master Files and oversee document quality and completeness
• Develop operational plans, risk mitigation strategies, and study status reports for internal and external stakeholders
• Contribute to department-level initiatives including SOP development and process optimization
• Set clear expectations for study team performance and foster a high-performing, inclusive culture
• Coach and mentor junior CTMs and Clinical Associates, promoting growth and development
• Communicate with empathy, clarity, and courage across cross-functional teams
• Champion collaboration and shared accountability across departments

Preferred Qualifications

• Experience in respiratory, immunology, or rare disease trials
• Familiarity with IND submissions and global study execution
• Knowledge of clinical systems (e.g., EDC, eTMF, CTMS)

Benefits

• Annual bonus
• Equity compensation
• Competitive benefits package