Spyre Therapeutics is a biotechnology company that aims to create next-generation inflammatory bowel disease (IBD) and other immune-mediated disease products by combining best-in-class antibody engineering, rational therapeutic combinations, and precision medicine approaches. Spyre’s pipeline includes extended half-life antibodies targeting α4β7, TL1A, and IL-23.

ROLE SUMMARY:

The Director, Drug Safety Physician will play a pivotal role on our Drug Safety & Pharmacovigilance team, helping to advance the development of our cutting-edge antibody portfolio. This position’s deliverables include: Individual Case Safety Report (ICSR) review and aggregate safety monitoring (DSUR, etc.), oversight of cases/AOSE for expedited safety reporting, contributing to safety assessment, safety surveillance, signal detection, risk management planning and strategy, clinical trial document review (protocol, IB, ICF), and ensuring pharmacovigilance compliance with global regulatory requirements.

KEY RESPONSIBILITIES:

• Perform triage and medical review of ICSRs (in or outside the global safety database), and oversight of cases/AOSE for expedited safety reporting
• Participate in the preparation, writing, and/or review of aggregate safety review documents (DSUR) and safety sections of relevant clinical trial documents and regulatory filings
• Participate in safety data review including safety surveillance activities and the evaluation & management of safety signals emerging from any data source
• Participate and present cases at safety management team meetings and lead safety surveillance and signal management meetings
• Participate in process improvement projects related to medical review and assessment. Assist the DSPV department head in developing and maintaining state-of-the-art Pharmacovigilance (PV) processes and procedures including SOPs, WI, surveillance plans
• Participate in safety presentation development for independent Data Monitoring Committee (iDMC) meetings and present safety data at such meetings
• Ensure that tasks are performed in the most efficient manner possible commensurate with quality, accuracy, and timeliness and in accordance with current global regulatory requirements
• Provide medical safety strategy and execution of benefit-risk management strategies for assigned products
• Provide safety input to clinical development plans, responses to HA or institutional review board/ ethics committee queries
• Provide guidance to the development of safety risk language, risk management strategy, pre-filing safety activities including safety table shells, integrated safety data review, integrated safety summary document review, and safety-focused publication development
• Provide input to other safety activities as requested