Job Details

Overview

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.

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The Role

Reporting to the VP of Clinical Development, the Director of Clinical Science will be responsible and accountable for the scientific implementation of the Clinical Development Plan at the program level across multiple studies. The incumbent will work closely with colleagues within Clinical Development, Clinical Operation, Data Management, Biostatistics and other relevant functions in facilitating clinical trial design and execution of multiple clinical trials, potentially including different indications, phases, and products. The position is a subject matter expert on managing key elements in outcome studies, including but not limited to protocol design, database set up, data review and interpretation, as well as endpoint and safety event adjudication. The position may serve in various internal and external roles as the Clinical Development representative, such as at study team meetings, Clinical Sub-Team (and/or Project Core Team) levels, as appropriate, contributing to discussions to ensure consistency across clinical programs, scientific meetings, and as an author or reviewer of study documents and other materials.

Responsibilities

• Develop key partnerships with the Medical Director/Medical Monitor in study design, startup, execution, and closeout activities; provide scientific rationale for design and implementation of clinical protocols, data collection systems, and study reports.


• Manage adjudication charters and process to ensure timely adjudication of endpoint and safety events.


• Collaborate with CROs and oversee clinical data review for program-level DSMB readiness; coordinate cross-program transparency and robustness.


• Lead content development for Steering Committee meetings; collaborate with external partners (e.g., Key Opinion Leaders) for scientific advice.


• Develop key strategic partnerships with Clinical Operations in study setup and execution activities, including start-up deliverables, study document reviews, vendor selection/manage, site engagement, patient recruitment and engagement activities.


• Work with matrix-based project teams (Clinical Development, Clinical Operations, Data Management, Biostatistics, and other functions) to ensure integration of project and functional goals toward milestones.


• Proactively identify risks, track critical paths, risk contingencies, and alternatives.


• Demonstrated experience in clinical development, trial management, data management, generation of research hypotheses, and publication/presentation of scientific information.


• Knowledge of data monitoring, safety, and adjudication committees; experience with data monitoring committees and safety committees.


• Proficient in data management tools, data flow, extraction, review, analyses, visualization; proficient in Microsoft Office, EDC, and data reporting tools.


• Knowledge of clinical science & research, GCP/ICH/FDA/EMEA guidelines, drug development process, study design, statistics, and clinical operations.


• Ability to work with cross-functional teams at protocol and program levels; excellent communication and presentation skills for expert and lay audiences.


• Team-oriented, highly motivated, execution-focused with a strong work ethic, able to thrive in a fast-paced, high-growth, entrepreneurial environment.

Qualifications

• Advanced degree in life sciences (PhD or PharmD).


• 5-8 years of experience in Clinical Development and/or clinical trial experience in pharma or CRO.


• Ability to work from SF Office 2 days per week (Tuesday and Wednesday).


• 25% business travel as needed.

Salary & Level

89bio considers a range of factors when determining salary and level. The expected salary range for this position based on the primary location for this position in Northern California is $199,500 - $230,000. The level is determined through the companys assessment approach.

The Perks

• Competitive health insurance coverage


• Employee Stock Purchase Plan (ESPP)


• Women's forum/mentoring


• Office in San Francisco, near shops and restaurants


• 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 the full inclusion of all qualified individuals and will provide reasonable accommodations for the hiring process where requested, unless it imposes an undue hardship.

Notice to Recruiters: 89bio does not accept unsolicited resumes; recruitment is managed through the 89bio Talent Acquisition Team.