Clinical Science Director

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.

THE ROLE

Reporting to the VP of Clinical Development, the Clinical Science Director 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 interpretation and 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.

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 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 the endpoint and safety events on the program level.
• Collaborate with CRO and oversee clinical data review for program-level DSMB readiness, coordinate cross programs to ensure transparency and robustness.
• Effectively manage charters and lead content development for Steering Committee meetings; Collaborate and serve as a liaison between external partners (e.g. Key Opinion Leaders) for scientific advice.
• Lead and strategize the generation and implementation of product development plan (inclusive of target product profile, clinical development plan) for one or more products.
• Develop key strategic partnerships with Clinical Operations in study set up and execution activities, including start-up deliverables, review of study documents, support vendor selection and management, site engagement, patient recruitment and engagement activities.
• Work with the matrix-based project team (Clinical Development, Clinical Operation, Data Management, Biostatistics and other relevant functions) to ensure integration of project and functional goals towards achieving project milestones and timetables. proactively identify risks, track critical paths, risk contingencies, and alternatives.
• Demonstrated experience in clinical development, study trial management, clinical database maintenance, generation of research hypotheses, and publication and presentation of scientific information.
• Knowledge of the establishment and management of data monitoring committees, safety committees, and adjudication committees.
• Proficient knowledge and hands-on skills to conduct database set up, data flow and extraction, data review, trend analyses and signal identification, data interpretation, and data visualization. Proficient in Microsoft Office, electronic data capture & data reporting tools, and electronic data management system tools.
• Proficient knowledge of clinical science & research, GCP/ICH/FDA/EMEA guidelines, drug development process, study design, statistics, and clinical operations.
• Demonstrated high-level of capability to work with cross-functional teams at the protocol and clinical program level.
• Excellent interpersonal skills, ability to cultivate strong internal/external network of relationships. Ability to lead and influence others.
• Excellent verbal and written communication and presentation skills, with an ability to interpret, synthesize and communicate complex clinical information to expert and lay audiences.
• Team oriented, highly motivated, execution focused with strong work ethic, ability to thrive in a fast speed, high growth, entrepreneurial environment.

THE QUALIFICATIONS

• Advanced degree in life sciences (PhD or PharmD)
• 8-10 years of experience of late stage (phase III outcome trials preferred) Clinical Development in the pharmaceutical industry or clinical research organization required
• Ability to work from SF Office 2 days (Tuesday and Wednesday) per week
• 25% business travel as needed

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 $199,500 - $230,000.

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.