Clinical Operations, Director

THE COMPANY

89bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases. The company's lead product candidate, pegozafermin (BIO89-100), is a specifically engineered glycoPEGylated analog of FGF21. Pegozafermin is being developed for the treatment of nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG).

THE ROLE

Reporting to the Executive Director of Clinical Operations, the Director of Clinical Operations will enhance the infrastructure to drive efficiency to ensure the execution of study programs to meet Company goals driving the Company' portfolio forward. The role also maintains and creates key partnerships with sites and vendors to maximize collaboration. In this role you will develop and standardize best practices among study teams; and partners with other Clinical Operations team members to maintain ecompliance with GCPs. The position is based in the San Francisco office and requires some domestic and international travel when conditions allow.

THE RESPONSIBILITIES

• Responsible for the implementation and quality execution of assigned clinical protocols according to 89bio SOPs, ICH/GCP and corporate and departmental program goals.
• Serves as a Study Team Lead to the multifunctional team to ensure clinical study/studies activities including study start-up, enrollment, maintenance, and close-out are executed per timeline and budget.
• Provide strategic and operational leadership for the Clinical Operations team for collaboration, engagement, execution, and interpretation of clinical programs
• Oversee study budget and accruals process.
• Lead CRO/Vendor selection process for outsourced activities, including developing 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.
• Develop CRO/Vendor oversight procedures and governance that can be used across all programs.
• Create infrastructure to ensure efficiency across all programs.
• Initiate "audit ready all the time" initiative that trains and ensure teams are managing the study with the end in mind.
• Ensure SOP and regulatory compliance of staff and clinical sites.
• Create partnerships internally/externally to maximize collaboration.
• Report status of clinical programs to project teams and management.
• Hire key staff members to ensure resources to execute programs.
• Supervise Clinical Operations study team members.
• Lead or participate in department training and development and revision of SOPs, systems and policies.
• Interact with investigators and/or thought leaders and maintain strong relationship.
• Collaborate with Clinical QA to support GCP inspection-readiness activities.
• Present a high profile role within the organization always displaying a positive attitude and offering constructive input as required.
• Travel up to 25%.

THE QUALIFICATIONS

• BA/BS degree in science and/or relevant scientific discipline or equivalent.
• 10 years' relevant biopharma Clinical Operations industry experience including 3 years of experience in managing phase 3 international trials.
• 5 years' experience management experience hiring, leading, and motivating teams/direct reports.
• Experience working in hepatology trials.
• Successful experience driving programs and leading initiatives within Clinical Operations.
• In-depth knowledge of FDA regulations, GCP and ICH guidelines.
• Proven experience developing and managing budgets.
• Successful experience overseeing vendors, driving towards and meeting results.
• Excellent communication and interpersonal skills, including strong command and presentation skills.
• Demonstrated history of prioritizing and multi-tasking.
• Outstanding judgment and problem-solving skills, risk analysis and mitigation.
• Success influencing up, down and across an organization with demonstrated experience. collaborating with internal and external partners.
• Strategic and forward-thinking.
• Proficiency with MS Office.
• Ability and willingness to travel (international and domestic).

SALARY

89bio considers a range of factors when determining compensation. These considerations mean actual compensation will vary. The range for this position is $210,000 - $235,000 and will be commensurate with experience.

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

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. Proof of Covid vaccination is a condition of employment.

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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