Senior Director, Drug Safety and Pharmacovigilance Operations

The posting, as Spyre Therapeutics wrote it

Spyre Therapeutics is a clinical-stage biotechnology company committed to developing next-generation therapies that elevate the standard in immunology by delivering more complete disease control, greater durability, and a simpler treatment experience for patients. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, IL-23, and IL-17A/F as well as rational combination programs.

Role Summary

The Senior Director, Drug Safety and Pharmacovigilance (DSPV) Operations will provide operational leadership for pharmacovigilance activities, including case management, vendor governance, regulatory compliance, the PV Quality Management System (QMS), inspection and audit readiness, training, and performance metrics. This individual will also oversee DSPV contracts, budgets, and invoices.

Serving as the subject matter expert for outsourced safety operations, the Senior Director will oversee case processing, expedited reporting, and activities related to the Argus global safety database (GSDB), including reporting, business continuity, and disaster-recovery planning.

Responsible for reports preparation and vendor management for GSDB related activities. Serves as lead for PV compliance, QMS, and inspection /audit readiness for the DSPV function, and for the organization and oversight of the Safety Management Plans (SMP), Safety Management Team (SMT) meetings, Vendor Oversight Plan (VOP).

As the case management lead, the Senior Director will monitor case-processing activities performed by patient support programs (PSPs), vendors, and business partners. This individual will ensure compliance with applicable study protocols, SMPs, VOPs, SOPs, work instructions (WIs), study plans, contractual obligations, and established key performance indicators (KPIs).

This position reports to the Senior Vice President, Drug Safety and Pharmacovigilance.

Key Responsibilities

Case Management and Safety Systems

• Provide oversight of end-to-end case processing for clinical development programs, ensuring timely, accurate, and compliant collection, review, processing, follow-up, reconciliation, and reporting of safety information.
• Serve as the operational subject matter expert and lead for the Argus global safety database, including workflows, vendor activities, data outputs, reporting, system compliance, and applicable business-continuity and disaster-recovery processes.
• Oversee expedited safety reporting, including SUSAR submissions, in accordance with applicable regulatory requirements and timelines.
• Establish and monitor case-processing workflows, KPIs, compliance metrics, and operational deliverables; review and escalate performance issues and trends.
• Monitor safety operations performed by PSPs, vendors, and business partners for compliance with protocols, SMPs, VOPs, SOPs, work instructions, study plans, contracts, and applicable regulations.
• Serve as the unblinded Drug Safety Operations representative, as r

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k 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 $295,000 to $312,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.
As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing life-changing products for patients.

Spyre Therapeutics, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Please be aware that official recruiters at Spyre Therapeutics only use email addresses with the domain “@spyre.com.” We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email.

Please also be aware that all job postings will be listed on our website at spyre.com/careers/.