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Medical Director
Medical Director89bio • San Francisco, CA, United States
Medical Director

Medical Director

89bio • San Francisco, CA, United States
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  • [job_card.temporary]
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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 Executive Medical Director, 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.

THE RESPONSIBILITIES

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

THE QUALIFICATIONS

  • MD or equivalent medical degree is required; board certification in Gastroenterology, Hepatology, or Internal Medicine with a focus on metabolic diseases preferred.
  • At least 5–8 years of industry experience in clinical development or medical monitoring, ideally with late‑phase experience in liver / metabolic diseases.
  • Demonstrated leadership in Phase 2 or 3 clinical trials, including protocol design, medical oversight, and regulatory engagement.
  • Experience working within or overseeing global, multi‑center trials and collaborating with CROs and external stakeholders.
  • Deep understanding of GCP, ICH guidelines, FDA / EMA regulations, and global drug development processes.
  • Excellent communication, critical thinking, and collaborative skills; ability to translate clinical data into strategic insights.
  • 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 $263,000 - $315,000.

    THE PERKS

  • Competitive health insurance coverage
  • 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.
  • Candidates must already hold work authorization, as visa sponsorship is not available for this role.
  • 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.

    #J-18808-Ljbffr

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