THE COMPANY

89bio is a clinical-stage biopharmaceutical company dedicated to the development of best-in-class therapies for patients with liver and cardiometabolic diseases who lack optimal treatment options. The company is focused on rapidly advancing its lead candidate, pegozafermin, through Phase 3 clinical development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) and severe hypertriglyceridemia (SHTG). Pegozafermin is a specifically engineered, potentially best-in-class fibroblast growth factor 21 (FGF21) analog with unique glycoPEGylated technology that optimizes biological activity through an extended half-life. The company is headquartered in San Francisco.

THE QUALIFICATIONS

• Bachelor’s degree in Life Sciences, Health Sciences, or related field required
• Advanced degree (Master’s, PharmD, MD, or PhD) preferred
• 12-18 years of progressive clinical operations experience with demonstrated leadership
• Extensive experience developing RFPs; selection, and demonstrated successful and effective management of CROs or other vendors in a results-driven culture
• Communicates with clarity (written and spoken) and possesses strong interpersonal skills both formal, and colloquial.
• Able to multi-task, prioritize, anticipate challenges; manage and lead teams by creating a clear sense of direction; leads by example and promotes collaboration, effective communication and leadership in others. Resilient, creative, capable problem-solver
• Demonstrates appropriate use of delegation, empowerment. However, ready to take over responsibility, where necessary.
• Able to rapidly enter into action with a sense of urgency and thrive under time-sensitive conditions; driven by a desire to deploy innovative approaches and technologies to deliver efficiencies and value.
• Resilient, creative, capable problem-solver
• Registrational-trial experience desired
• Thorough knowledge of ICH/GCP and appropriate regulatory guidelines; regulatory inspection experience
• Exceptional leadership skills with ability to influence and drive results across all organizational levels
• Proven ability to thrive in fast-paced, high-pressure environments while maintaining attention to detail

THE ROLE

Reporting to the SVP, Clinical Operations, the Director, Clinical Operations will be primarily responsible for driving organizational excellence, compliance, and performance management across our Phase III clinical trial portfolio. The candidate will be a collaborative, agile leader with global clinical development experience, and have a passion for operational excellence. This role will effectively manage the day-to-day operations of several phases of drug development and/or multiple high-complexity projects, as well as clinical trial and department improvement initiatives. This position combines full-cycle trial planning, execution, and reporting of clinical trials with leadership; and works in study teams and across matrix teams of direct and indirect reports.