Clinical Operations Director

Overview

89bio is a clinical-stage biopharmaceutical company dedicated to the development of best-in-class therapies for patients with liver and cardiometabolic diseases. The company is focused on advancing its lead candidate, pegozafermin, through Phase 3 clinical development for metabolic dysfunction-associated steatohepatitis (MASH) and severe hypertriglyceridemia (SHTG). Pegozafermin is a glycoPEGylated FGF21 analog with extended half-life. The company is headquartered in San Francisco.

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The Role

Reporting to the SVP, Clinical Operations, the Director, Clinical Operations will be responsible for driving organizational excellence, compliance, and performance management across the Phase III clinical trial portfolio. The candidate will be a collaborative, agile leader with global clinical development experience and a passion for operational excellence. This role will manage 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.

Responsibilities

Clinical Trial Management

Demonstrate a deep understanding of industry trends and challenges, and translate them into actionable 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 program priority

Lead strategy for identification, assessment, selection, engagement, management, and oversight of vendors and sites

Develop and implement action plans to develop, execute and deliver clinical studies with focus on efficiency, speed, cost and quality

Build and maintain relationships with Investigators and study site personnel, CRAs, and CRO teammates to create partnerships; provide proactive oversight of vendor performance

Oversee, plan, and conduct internal team and investigator training / meetings

Collaborate with Regulatory, Quality, CMC, Biometrics, Finance, Program Management, and other functions

Use tools to track, oversee, and communicate program status to key stakeholders

Oversee and contribute to inspection readiness activities for regulatory inspections

Ensure execution of trials according to study protocol, SOPs, GCP and regulations

Prepare or contribute to protocols, investigator brochures, clinical study reports, regulatory filings, annual reports, ICFs, CRFs, study manuals, and other clinical documents

Budget and Resources

Strong financial acumen for management of clinical trial budgets and invoices

Understand department business levers that impact budgets to make critical decisions

Contribute to improving departmental methods, techniques, and standards for projects, process, and people

Prepare materials for internal governance and financial review cycles

Supervisory and Development

Hire, develop and retain diverse talent; set clear goals; coach performance and career development

Ensure competencies and skills align with trial requirements and roles

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

Experience developing RFPs and managing CROs or vendors in a results-driven culture

Clear written and verbal communication with strong interpersonal skills

Ability to multi-task, prioritize, anticipate challenges; lead teams with clear direction; promote collaboration and leadership

Ability to delegate appropriately while taking ownership when needed

Able to act with urgency under time-sensitive conditions and leverage innovative approaches to deliver efficiencies

Thorough knowledge of ICH / GCP and regulatory guidelines; regulatory inspection experience

Strong leadership to influence and drive results across all levels

Thrives in fast-paced, high-pressure environments with attention to detail

Salary & Level

89bio considers a range of factors when determining salary and level. Actual salary and level may vary. The expected salary range for this position in Northern California is $205,000 – $245,000.

Offer and level are determined during the interview process and based on factors such as education, experience, qualifications, location, transferable skills, licenses / certifications, and other job-related factors permitted by law.

The Perks

Competitive health insurance coverage

Employee Stock Purchase Plan (ESPP)

Women's forum / mentoring

Office based in San Francisco

Opportunities to engage with co-workers in-person and remotely

Conditions of Employment

Background investigations are required for all positions by 89bio, consistent with applicable law.

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 disability. 89bio is committed to full inclusion and provides reasonable accommodations in the hiring process and for performing essential job functions where not an undue hardship. Notice to Recruiters : 89bio does not accept unsolicited resumes and recruitment is managed through the 89bio Talent Acquisition Team.

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