Job Description
Job Description
SALARY: $325,000 - $345,000 yr.
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 Chief Medical Officer, the Sr. Medical Director, DSPV will be responsible for providing scientific and risk management expertise in support of 89bio's development compound(s). This position holds the primary responsibility for medical review of individual case safety reports which include confirmation of MedDRA coding, assessments (seriousness and expectedness), case queries, and analysis of similar events as needed. The position will also function as an interdepartmental project lead in the handling and analyses of safety data from clinical trial data and literature reports. The Safety Physician is a key contributor working closely with both internal and external Safety staff, as well as with cross-functional teams such as Clinical Development, Clinical Operations, Biometrics, Medical Writing, Regulatory Affairs, and other multi-disciplinary teams and committees contributing to signal detection and to the risk evaluation and management of safety data.
THE RESPONSIBILITIES
The major duties and responsibilities will include but are not limited to the following:
Provides medical reviews for SAEs, SUSARs, and other Safety reports to include case assessments and input to Analysis of Similar Events as required.
Oversees the Safety Review Committee in collaboration with internal and external cross-functional teams.
Participates in the presentation and discussion of safety data at Data Safety Monitoring Board meetings.
Contributes to the preparation and review of the safety sections of the Drug Safety Update Reports (DSURs), Investigator Brochure (IB)/Reference Safety Information, clinical trial protocols and final reports, the informed consent form (ICF), and safety reporting forms.
Contributes to the development and/or reviews of SOPs.
Leads and/or supports signal detection and literature review activities.
Contributes to regulatory submission documents, interactions with global regulatory agencies and/or external stakeholders, and health authority requests.
Participates in the MedDRA coding review of reported (non-serious) adverse events.
Ensure patient safety while adhering to the highest quality and ethical standards.
THE QUALIFICATIONS
Medical Degree (MD or equivalent) required
8+ years of medical safety experience (Safety Science/Risk Management) gained in Pharmacovigilance, Clinical Research, or Clinical Development within the Pharmaceutical industry.
Experience operating in a global pharmacovigilance organization strongly preferred.
ICSR Medical Review experience including knowledge of MedDRA and WHODrug coding dictionaries.
Extensive signal detection/risk management experience with knowledge of biostatistical methods used in drug development and Safety surveillance, analysis and reporting.
Working knowledge of ICH, US and worldwide Safety reporting regulations and requirements.
Expertise in or exposure to therapeutic areas (Hepatology and/or Endocrinology) is a plus but not required.
Strong organizational, project management, and leadership skills.
Excellent written and verbal communication skills.
Ability to work in the SF office two days a week (Tuesday & Wednesday)
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 $325,000 - $345,000.
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 protected veteran status, or based on disability status.
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.
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Job Tags
Work at office, Remote work, Worldwide, 2 days per week,