Title: Medical Director

Location: San Francisco Bay Area

Specialties: Gastroenterology, Hepatology, Internal Medicine

Base: $263,000 - $315,000

401k matching: 401k match

Summary

The Medical Director provides medical and scientific expertise to support Phase 3 clinical trials focused on liver and metabolic diseases, including medical oversight, safety signal detection, protocol compliance, clinical data review, regulatory submissions, and collaboration with cross-functional teams and external partners. The role requires leadership in late-phase clinical trials and interaction with CROs, investigators, and regulatory authorities, with travel expected up to 30%.

Added on: 07/17/2025

Full Job Description

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 ROL

EReporting to the Executive Medical Director the Medical Director will be primarily responsible for providing medical and scientific expertise to support our Phase 3 clinical MASH program primarily focused on cirrhosis. The Medical Director will serve as a key clinical leader working cross-functionally with Clinical Operations, Regulatory Affairs, Pharmacovigilance, Biometrics, and external partners to ensure the integrity, safety, and success of our late-stage trials


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SPECIAL ADVISO

RYThe 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 Scam


s.
THE RESPONSIBILITI

ES Serve as one of the Medical Monitors for ongoing Phase 3 trials, overseeing medical oversight, safety signal detection, and protocol complian ce.Provide clinical and scientific input into trial design, protocols, amendments, and study conduct documentation (e.g., IBs, ICFs, SAP s).Participate in clinical data review, interpretation, and decision-making, including support for database locks, interim analyses, and regulatory submissio ns.Collaborate with the Safety/Pharmacovigilance team to monitor and assess adverse events and serious adverse events, ensuring timely escalation and communicati on.Lead or participate in Clinical Study Team (CST) meetings and contribute to cross-functional program team discussio ns.Review and contribute to regulatory documents, including briefing books, INDs, NDAs, and responses to health authoriti es.Provide medical expertise in interactions with CROs, investigators, DSMBs, and KOLs to support trial execution and data integri ty.Remain current on therapeutic trends, competitive landscape, and emerging data in MASH, liver fibrosis, and metabolic diseas es.Requires successful cross-collaboration with groups such as clinical science, clinical operations, regulatory, biometrics, safety and other functions as needed throughout the organizat ionRequires travel to sites, scientific meetings, CRO’s and other meetings as needed (25-30


%).
THE QUALIFICAT

IONSMD or equivalent medical degree is required; board certification in Gastroenterology, Hepatology, or Internal Medicine with a focus on metabolic diseases prefer red.At least 5–8 years of industry experience in clinical development or medical monitoring, ideally with late-phase experience in liver/metabolic disea ses.Demonstrated leadership in Phase 2 or 3 clinical trials, including protocol design, medical oversight, and regulatory engagem ent.Experience working within or overseeing global, multi-center trials and collaborating with CROs and external stakehold ers.Deep understanding of GCP, ICH guidelines, FDA/EMA regulations, and global drug development proces ses.Excellent communication, critical thinking, and collaborative skills; ability to translate clinical data into strategic insig


hts.
SALARY &

LEVEL89bio 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 $263,000 - $315

,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 co verageGenerous PTO all owance401k matchEmployee Stock Purchase Plan (ESPP)Commuter Be nefitsWomen's forum / men toringOffice based in the heart of San Francisco, near plenty of shops and resta urantsFun opportunities to engage with co-workers in-person and re


motely
CONDITIONS OF EMP

LOYMENTBackground investigations are required for all positions by 89bio, consistent with applicab

le 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 disa

bility.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 ha

rdship.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 Acquisitio


n Team.