Senior Clinical Trial Manager

Senior Clinical Trial Manager – IBD Biotech - US-based, Key Early Hire Location: United States (Remote/Flexible) About the Role My client, a pioneering small biotech developing transformative therapies for IBD, is seeking a Senior Clinical Trial Manager to join their growing team. This is a unique opportunity to take a leadership role as a trial lead , shaping clinical strategy and execution from the ground up, and becoming one of the first key hires in the U.S. In this role, you will have direct impact on the design, management, and delivery of early- to mid-stage clinical trials. You will collaborate closely with cross-functional teams—including clinical operations, regulatory, medical affairs, and external vendors—to ensure trials are executed efficiently, on time, and in compliance with regulatory standards. Key Responsibilities Lead and manage clinical trials in IBD from start-up through close-out, acting as the trial lead for pivotal studies. Oversee timelines, budgets, and operational plans to ensure successful execution of studies. Serve as primary point of contact for internal teams, external vendors, and clinical sites. Support regulatory submissions, safety reporting, and quality compliance initiatives. Contribute to the development of clinical protocols, informed consent forms, and study-related documentation. Mentor and guide junior team members as the organization grows. Travel up to 30% Qualifications Bachelor’s degree in life sciences, nursing, pharmacy, or related field (advanced degree preferred). 5–8+ years of clinical trial management experience , ideally in gastroenterology, IBD, or immunology. Demonstrated success as a trial lead on complex, multi-site studies. Strong knowledge of GCP, FDA/EMA regulations, and clinical trial operational best practices. Excellent leadership, communication, and problem-solving skills. Comfortable in a dynamic, fast-paced startup environment and excited by the opportunity to make a high-impact contribution. Why This Role is Exciting Be one of the first U.S. hires at an innovative biotech with a clear mission to improve outcomes for IBD patients. Direct influence on trial design and clinical strategy. Work in a collaborative, entrepreneurial environment where your contributions are highly visible. Competitive compensation package with equity options. Send your resume to View email address on click.appcast.io #J-18808-Ljbffr