Director of Clinical Operations

Job Description

Job Description

Salary : 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.

SPECIAL ADVISORY

The FTC has an advisory out on the domain 89biocareers.com if you are contacted by any group using a similar, but not our exact domain 89bio.com, please Report any Scams.

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.

THE RESPONSIBILITIES

Clinical Trial Management

• Demonstrate a deep understanding of industry trends and challenges, and proactively translating them into specific steps at the functional level
• Provide technical guidance to ensure that clinical trials are properly defined, planned, and executed
• Accountable for global or regional operational leadership on one or more clinical trials, depending on programs priority and breadth
• Lead strategy for identification, assessment, selection, engagement, management, and oversight of appropriate vendors and sites
• Based on thorough understanding of the mechanics of conducting clinical trials, develop and implement action plans and tactics to develop, execute and deliver clinical studies with focus on efficiency, speed, cost and quality
• Build and maintain relationships with Investigators and other study site personnel, CRAs, and CRO team members to create a true partnership. Provide proactive and consistent oversight of vendor performance
• Oversee, plan, and conduct internal team and investigator training / meetings
• Cross-collaboration proficiency with other functions such as Regulatory, Quality, CMC, Biometrics, Finance, Program Management, etc.
• Use all available tools to track, oversee / manage and communicate program status to all key stakeholders
• Oversee and contribute to inspection readiness activities that support audits and regulatory inspections related to clinical trial conduct
• Ensure execution of trials according to the study protocol and procedures, SOPs, GCP and regulations
• Write, prepare, or contribute with the preparation of protocols, investigator brochures, clinical study reports, clinical sections of regulatory filings, annual reports, ICFs, CRFs, study manuals, and other clinical documents, etc.

Budget and Resources

Department Leadership

Supervisory and Development

THE QUALIFICATIONS

SALARY & LEVEL

89bio considers a range of factors when determining salary and level. These considerations mean actual salary and level may vary. The expected salary range for this position based on the primary location for this position in Northern California is $205,000 $245,000.

89bios role / level assessment approach involves assessing candidates during the interview process before confirming the level / title designation. The level assessment is considered on a case-by-case basis. Offer and level is based on factors such as : education, experience, qualifications, geographic location, transferable skills, licenses / certifications and other job-related factors permitted by law.

THE PERKS

CONDITIONS OF EMPLOYMENT

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or based on disability.

89bio is committed to the full inclusion of all qualified individuals. As part of this commitment, 89bio will ensure that persons with disabilities are provided reasonable accommodations for the hiring process, and / or to perform essential job functions where the requested accommodation does not impose an undue hardship.

Notice to Recruiters : To protect the interest of all parties, 89bio does not accept unsolicited resumes and we ask that employees, hiring managers and executives not be contacted directly. All recruitment is managed through the 89bio Talent Acquisition Team.