THE COMPANY

89bio is a clinical-stage biopharmaceutical company dedicated to the development of best-inclass 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

• BA/BS in related life science field, e.g. nursing or equivalent years of experience.
• 8-12 or more years of relevant experience
• Global drug development experience in metabolic disorders preferred
• Experience in CRO selection and management including drafting request for proposals (RFPs), bidding process, etc.
• In-depth knowledge of FDA regulatory requirements and medical practice/techniques
• and terminology
• Success working within a team and independently, with minimal supervision
• Willing to travel 25% domestically and international travel
• Strong organizational/prioritization of multiple tasks under tight timeframes with close attention to detail
• Excellent communication and interpersonal skills
• Excellent computer skills
• Advanced degree desired
• Experience with Phase 1 trials is preferred

THE ROLE

The Senior Clinical Trial Manager Contractor will be a key member of the 89bio Clinical Operations team. The Contractor will function as the study team leader to plan, organize and coordinate assigned operational aspects of a clinical study from protocol development through database lock. The Contractor will ensure timely conduct of clinical studies according to protocols, Good Clinical Practice (GCP), Standard Operating Procedures (SOPs) and all applicable regulations governing the conduct of clinical trials while meeting Company goals and objectives.

THE RESPONSIBILITIES

• Responsible for the implementation and quality execution of assigned clinical protocol according to 89bio SOPs, ICH/GCP and corporate and departmental program goals
• Lead or support timelines and budget management to optimize achievement of study goals and milestones for assigned regions
• Lead or support CRO/Vendor selection process for assigned activities, including developing an RFP, managing the bidding process, analysis of proposals, budgets, and leading and documenting vendor selection decisions. Includes review of Scope of Work, budgets and negotiating contracts through execution
• Ensure quality and timely delivery of clinical study data
• May chair or participate in meetings or conference calls with multi-disciplinary study team, regional monitors, or vendors (e.g., CROs, central Labs)
• Coordinate activities with other functional groups, such as Regulatory, Safety, Biostatistics, etc.
• Work with Clinical Research Organizations (CROs) to ensure coordination of Sponsor and CRO responsibilities, obligations are being met
• Lead or support developing critical study documents, including, but not limited to informed consent form templates, various management plans and study trackers
• Monitor site performance on an ongoing basis and escalate any infringements, breaches and misconduct, fraud, and negative trends
• Ongoing protocol deviation tracking, reporting, and trending
• Assist in auditing of clinical trial data for accuracy and consistency and arrange correction of errors as appropriate
• Manage central and/or local labs and supplies
• Coordinate supplies for specimen collection and track shipments of samples for assays.
• Document all trial information with adherence to applicable guidelines and SOPs
• Remain current with ICH guidelines, FDA regulations, and company SOPs May contribute to the identification and development of departmental policies. May recommend and implements innovative processes to improve and impact clinical trial management and deliverables
• Lead or support GCP inspection-readiness activities
• Travel up to 25%