Sr. Medical Director, Drug Safety & Pharmacovigilance

THE COMPANY

89bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases. The company's lead product candidate, pegozafermin (BIO89-100), is a specifically engineered glycoPEGylated analog of FGF21. Pegozafermin is being developed for the treatment of nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG).

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.

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

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 travel to SF office 2 times per week or as travel policy requires.

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.

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.
• We require all employees to be fully vaccinated against COVID-19, as part of our commitment to ensuring a safe workplace for our team. Proof of vaccination will be required. Reasonable accommodations will be considered for individuals with medical or religious exemptions, in accordance with applicable laws.

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.

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.