Director / Senior Director, Clinical Operations

Zag Bio•Cambridge, MA

22d•Remote

About The Position

We are seeking an experienced and highly motivated Director / Senior Director of Clinical Operations to lead the operational execution of the Company’s 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.

Requirements

Bachelor’s 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

Nice To Haves

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

Responsibilities

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
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