Director, Drug Safety Physician

The role

The Director, Drug Safety Physician will advance the development of an antibody portfolio through ICSR review and aggregate safety monitoring. This role provides medical safety input for clinical trial documents and manages safety surveillance, signal detection, and risk management planning.

What you will do

• Perform triage and medical review of ICSRs and oversight of cases for expedited safety reporting
• Lead cross-functional medical review discussions pertaining to ICSR review
• Prepare, write, and review aggregate safety review documents and safety sections of clinical trial documents
• Lead review of scientific literature to support aggregate safety analyses
• Participate in safety data review, safety surveillance, and evaluation of safety signals
• Co-present cases at safety management team and safety review team meetings
• Participate in process improvement projects related to medical review and PV compliance
• Assist in developing and maintaining Pharmacovigilance processes, SOPs, and safety plans
• Participate in safety presentation development for iDMC meetings
• Provide medical safety strategy and execution of benefit-risk management strategies

Required qualifications

• MD
• 6+ years of related Clinical Development Drug Safety/Medical Review experience within the biotech/pharmaceutical industry
• Working experience / proficiency in Argus global safety database and medical review activities
• Working experience in safety surveillance and signal detection activities
• Knowledge of global pharmacovigilance regulations (EMA, FDA, etc.)

Nice to have

• A degree in epidemiology (Masters in Public Health, Masters of Science in Epidemiology, Doctor of Philosophy in Epidemiology, or Doctor of Public Health)
• Several years’ working knowledge in Epidemiology/Pharmacoepidemiology
• 2-3 years Medical Device safety experience

Benefits

• Market competitive compensation and benefits package
• Performance bonus
• Equity grant opportunities
• Health, welfare & retirement benefits
• Unlimited PTO
• Two, one-week company-wide shutdowns each
• Professional development opportunities

About the company

Spyre Therapeutics is a clinical-stage biotechnology company committed to developing next-generation therapies in immunology. Their pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, IL-23, and IL-17A/F.