[Hiring] Director, Drug Safety Physician @Spyre Therapeutics

Role Description

The Director, Drug Safety Physician, will play a pivotal role within the Drug Safety & Pharmacovigilance (DSPV) 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/Analysis of Similar Events (AOSEs) for expedited safety reporting
• Contributing to ongoing safety assessment, safety surveillance, signal detection, risk management planning, and safety strategy
• Providing medical safety input into key clinical trial document reviews, including protocols, IB, ICF
• Ensuring pharmacovigilance compliance with global regulatory requirements

The position reports to Sr VP, Drug Safety and Pharmacovigilance with a dotted line reporting relationship to the Medical Review Lead.

Qualifications

• MD with 6+ years of related Clinical Development Drug Safety/Medical Review experience within the biotech/pharmaceutical industry
• A degree in epidemiology (Masters in Public Health, Masters of Science in Epidemiology, Doctor of Philosophy in Epidemiology, or Doctor of Public Health) or several years’ working knowledge in Epidemiology/Pharmacoepidemiology is highly preferred
• Working experience / proficiency in Argus global safety database and medical review activities
• Working experience in safety surveillance and signal detection activities
• 2-3 years Medical Device safety experience is a strong preference
• Knowledge of global pharmacovigilance regulations (EMA, FDA, etc.) relevant to the activities and responsibilities described above
• Excellent analytical and problem-solving skills, with the ability to interpret complex data and translate findings into actionable drug development strategies
• Excellent communication and interpersonal skills, with the ability to motivate teams and collaborate effectively across functions

Requirements

• Perform triage and medical review of ICSRs (in and/or outside the global safety database)
• Lead cross-functional medical review discussions pertaining to Individual Case Safety Report (ICSR) review
• 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 and/or lead review of scientific literature, including preparation of written summaries to support aggregate safety analyses
• Participate in safety data review including safety surveillance activities and the evaluation & management of safety signals emerging from any data source
• Participate and co-present cases at safety management team (SMT) and safety review team (SRT) meetings
• Co-lead safety surveillance and signal management meetings
• Participate in process improvement projects related to medical review and assessment, safety surveillance, and relevant aspects of PV compliance
• Assist the DSPV department head in developing and maintaining state-of-the-art Pharmacovigilance (PV) processes and procedures including SOPs, WI, safety management plans, and safety surveillance plans
• Participate in safety presentation development for independent Data Monitoring Committee (iDMC) meetings
• Collaborate closely and assist the Medical Review Lead and other physicians on the team on the ongoing review of cases
• Develop a unified approach for medical review of ICSRs, safety presentations, and provide ongoing input into study protocols, periodic safety reports (DSURs), safety management plans, etc.
• Lead epidemiology projects with relevance for safety and pharmacovigilance
• Ensure that all assigned activities are executed efficiently 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 input into 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
• Other duties as assigned

Benefits

• Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company
• Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
• Unlimited PTO
• Two, one-week company-wide shutdowns each year
• Commitment to provide professional development opportunities
• Remote working environment with frequent in-person meetings to address complex problems and build relationships
• The expected salary range offer for this role is $280,000 to $311,000