Director / Senior Director, Clinical Operations

We are seeking an experienced and highly motivated Director / Senior Director of Clinical Operations to lead the operational execution of the Companys first clinical program in Type 1 diabetes as it advances into early-phase clinical trials. Reporting to the Chief Medical Officer, this individual will play a critical role in building and executing clinical operations strategy in a fast-paced, start-up environment.

The successful candidate will embrace a hands-on ethos, thrive in ambiguity, and bring a pragmatic, detail-oriented approach to trial execution. This role will work closely with cross-functional colleagues across clinical development, regulatory, translational science, and external partners.

Job Responsibilities

Reporting to the Chief Medical Officer, the incumbent will be responsible for the planning, execution, and oversight of early-phase clinical trials, with responsibilities including:

• Lead clinical operations strategy and execution for first-in-human and early-phase clinical studies in Type 1 diabetes
• Develop and maintain integrated clinical trial plans, timelines, budgets, and risk mitigation strategies
• Provide operational input into clinical development plans, study protocols, and investigator brochures
• Select, manage, and oversee CROs, vendors, and other external partners to ensure delivery against scope, timeline, budget, and quality expectations
• Oversee site feasibility, selection, initiation, monitoring, and close-out activities
• Ensure trials are conducted in compliance with GCP, SOPs, and applicable regulatory requirements
• Support preparation of clinical sections of regulatory submissions, including INDs, amendments, and interactions with regulatory authorities

Additional responsibilities include:

• Day-to-day operational oversight of clinical trial conduct, including issue resolution and proactive risk management
• Development and implementation of clinical operations processes, templates, and SOPs appropriate for a growing organization
• Management of clinical trial budgets, forecasts, and vendor invoices
• Contribution to clinical governance activities, including internal reviews, data reviews, and study team meetings
• Support investigator engagement and communication, including KOL interactions as appropriate
• Maintain accurate and inspection-ready trial documentation (eTMF, trial master files, vendor records)
• Participate in cross-functional planning to support pipeline expansion and future clinical programs

Required Qualifications and Experience

• Bachelors degree in life sciences or related discipline; advanced degree preferred
• 10+ years of progressive clinical operations experience in biotech and/or pharmaceutical industry, with increasing responsibility for trial execution
• Hands-on experience leading early-phase (Phase 1 and/or Phase 1b/2) clinical trials
• Strong working knowledge of GCP, ICH guidelines, and FDA regulatory requirements
• Demonstrated experience managing CROs and external vendors in a sponsor-oversight role
• Ability to operate independently in a small company environment with limited infrastructure
• Excellent organizational, communication, and problem-solving skills
• Willingness to be both strategic and highly execution-focused

Preferred Qualifications:

• Prior experience supporting clinical programs in immunology, autoimmunity, endocrinology, or metabolic diseases
• Experience contributing to IND submissions and early regulatory interactions
• Prior experience in a start-up or emerging biotech environment

Zag Bio values the diversity of our workforce and maintains a deeply respectful, values-driven working environment. We are committed to equal employment opportunities and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any characteristic protected under applicable law.

We are not accepting unsolicited resumes from employment agencies for any employment opportunities at this time.

Flexible work from home options available.