Vice President, Pharmacovigilance

Role Summary:

The Vice President of Pharmacovigilance at Spyre Therapeutics will lead and oversee all aspects of pharmacovigilance and patient safety activities within the company. This role is pivotal in ensuring the safety of our investigational products, fostering a culture where safety is integrated into every aspect of our drug development process. This individual will ensure the alignment of our PV strategies with the company’s corporate goals, cultivating innovation, and maintaining the highest standards of clinical excellence to drive the successful development and commercialization of our products. The Vice President of Pharmacovigilance will possess a deep understanding of Immunology and Inflammation, strong leadership skills and a track record of successful collaborations with cross-functional teams. This individual will report to the Chief Medical Officer and will be based remotely.

Key Responsibilities:

• Strategic Leadership: Lead and build the pharmacovigilance and risk management function, establishing and maintaining a safety infrastructure that prioritizes "safety by design" in all development activities. Lead safety review committee, clinical trial-specific safety review committees, and, where applicable, data monitoring committees.
• Safety Surveillance: Design, direct, and conduct ongoing safety surveillance, signal detection, and risk benefit assessments of the company’s drug products using internal and external resources to ensure delivery of high-quality pharmacovigilance services. Implement risk mitigation strategies as needed.
• Regulatory Compliance: Ensure compliance with global safety regulations and guidelines, and lead responses to safety-related inquiries from regulatory authorities.
• Safety Documentation: Contribute to the preparation and review of safety documents, including Development Safety Update Reports (DSURs), safety reports. Provide oversight of all clinical safety activities and processing of SAEs through the entire lifecycle including preparation of analyses of similar events (AOSE) for unexpected and related serious adverse events (SUSARs) from clinical trials.
• Vendor management: Oversee management of safety database and pharmacovigilance operations for investigational products.
• Cross-Functional Collaboration: Collaborate with Clinical Development, Regulatory Affairs, Clinical Operations, and Quality teams to integrate safety considerations into our company strategy.
• External Representation: Serve as the primary contact for safety-related issues, including interactions with regulatory authorities and management of safety service providers.
• Budget Management: Manage the pharmacovigilance budget and resources, including both internal teams and external contractors.
• Continuous Improvement: Drive continuous improvement in pharmacovigilance practices, ensuring readiness for regulatory inspections and audits.
• Other duties as assigned.

Ideal Candidate:

• Education and experience: M.D., D.O., or M.B.B.S. required with a minimum of 10 years of global experience in drug safety within the biotechnology or pharmaceutical industry. Immunology and Inflammation experience is strongly preferred.
• Pharmacovigilance Skills: Deep understanding of risks and risk mitigation steps related to safety signals and pharmacovigilance.
• Leadership: Proven track record of leading and managing pharmacovigilance teams and vendors. Strong strategic thinking and decision-making skills. Ability to lead cross functional study teams in a growing and dynamic organization.
• Communication: Excellent verbal and written communication skills. Ability to present complex medical information to diverse audiences.
• Regulatory Knowledge: In-depth understanding of regulatory requirements and guidelines (e.g., FDA, EMA).
• Interpersonal Skills: Strong interpersonal and relationship-building skills. Ability to lead and motivate teams and collaborate effectively across functions.

What We Offer:

• 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
• 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 $350,000 to $400,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.