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
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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 program's 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
- Strong financial acumen necessary for the management of clinical trial budgets (develop and reforecast budgets) and invoices
- Demonstrate an understanding of the department's business levers that impact budgets to make critical business decisions for the department and/or project
Department Leadership
- Contribute to internal efforts to establish/improve departmental methods, techniques, and standards for projects, process, and people
- Responsible for the preparation of materials for internal governance and / or financial review cycles
Supervisory and Development
- Hires, develops and retains diverse top talent on the team. Sets clear goals for the team and individual direct reports. Coaches direct reports on their performance, development and career interests
- Ensures the competencies and skills required for the trial team are consistent with defined requirements and assigned 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
- 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
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.
89bio's 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
- Competitive health insurance coverage
- Generous PTO allowance
- 401k match
- Employee Stock Purchase Plan (ESPP)
- Commuter Benefits
- Women's forum / mentoring
- Office based in the heart of San Francisco, near plenty of shops and restaurants
- Fun 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 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.
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