[Hiring] Director, Drug Safety Physician @Spyre Therapeutics
Role Description
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)
• 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
• 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 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 meetings and 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, surveillance plans
• Work closely and assist the Medical Review Lead on the ongoing review of cases and in developing a unified approach for medical review of ICSRs, safety presentations, and provides ongoing input on study protocols, periodic reports (DSUR), safety management plans etc.
• Participate in safety presentation development for independent Data Monitoring Committee (iDMC) 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 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
• Provide input to other safety activities as requested
• Other duties as assigned
Qualifications
• MD with 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
• 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
Benefits
• Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly
• 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 $315,000. Actual pay offered may vary depending on job-related knowledge, experience, education, and geographic location
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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)
• 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
• 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 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 meetings and 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, surveillance plans
• Work closely and assist the Medical Review Lead on the ongoing review of cases and in developing a unified approach for medical review of ICSRs, safety presentations, and provides ongoing input on study protocols, periodic reports (DSUR), safety management plans etc.
• Participate in safety presentation development for independent Data Monitoring Committee (iDMC) 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 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
• Provide input to other safety activities as requested
• Other duties as assigned
Qualifications
• MD with 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
• 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
Benefits
• Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly
• 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 $315,000. Actual pay offered may vary depending on job-related knowledge, experience, education, and geographic location
Apply tot his job
Apply To this Job