---
title: 'Director, Drug Safety Physician at Spyre Therapeutics'
canonical: 'https://feeny.ai/job/director-drug-safety-physician-spyre-therapeutics-united-states-34byjx96nsbr'
type: 'job'
last_seen: '2026-10-27'
---

# Director, Drug Safety Physician at Spyre Therapeutics

- **Company:** Spyre Therapeutics
- **Location:** United States
- **Work type:** remote
- **Posted:** 2026-09-30
- **Last confirmed live:** 2026-10-27
- **Apply:** https://job-boards.greenhouse.io/spyretherapeutics/jobs/5437052008

## Job description

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 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. The role will also provide 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.

Key Responsibilities:

- Perform triage and medical review of ICSRs (in and/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
- Participates in and/or leads 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 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, safety management plans, and safety surveillance plans
- Participate in safety presentation development for independent Data Monitoring Committee (iDMC) meetings
- Collaborate closely and assists the Medical Review Lead and other physicians on the team on the ongoing review of cases and in developing a unified approach for medical review of ICSRs, safety presentations (relevant to medical review of ICSRs and/or safety surveillance aspects), and provides ongoing input into study protocols, periodic safety reports (DSURs), safety management plans etc.  Lead epidemiology projects with relevance for safety and pharmacovigilance (natural history of disease, comorbidities, class effects, population health data, real-world drug safety monitoring, literature searches, signal detection and data mining, comparative effectiveness and safety research)
- 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

Ideal Candidate:

- MD with 6+ years of related Clinical Development Drug Safety/Medical Review experience within the biotech/pharmaceutical industry (medical review of ICSRs and periodic reports)
- 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

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 $280,000 to $311,000. 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/.

## About Spyre Therapeutics

## Company Overview
- **One-liner**: Spyre Therapeutics is a clinical-stage biotechnology company developing next-generation antibody therapies and rational combinations to elevate the standard of care for inflammatory bowel disease (IBD) and other immune-mediated diseases.
- **Entity Type**: Public (NASDAQ: SYRE [ir.spyre.com](https://ir.spyre.com/overview))
- **Headquarters**: Not publicly available (company operates 100% remote with frequent in-person meetings [job-boards.greenhouse.io](https://job-boards.greenhouse.io/spyretherapeutics))
- **Founded**: Not publicly available
- **Founders**: Not publicly available

## Core Business
- **Primary industry/industries**: Biotechnology / Biopharmaceuticals / Immunology
- **Target customers**: B2B (partners, healthcare providers, payers); primarily focused on patients with IBD (Crohn’s disease, ulcerative colitis) and other immune-mediated conditions
- **Mission or purpose statement**: “Develop potentially best-in-class therapeutics for people living with IBD” by combining best-in-class antibody engineering, dose optimization, and rational therapeutic combinations [spyre.com](https://www.spyre.com/)

## Products & Services
Spyre’s pipeline consists of investigational extended half-life antibodies targeting validated mechanisms, designed for subcutaneous administration and potentially improved efficacy and convenience:
- **SPY001 (α4β7 integrin inhibitor)**: Phase 3-ready anti-integrin antibody with extended half-life; targeting gut-selective inflammation control [spyre.com](https://www.spyre.com/pipeline)
- **SPY120 (TL1A antibody)**: Phase 1/2 anti-TL1A antibody targeting fibrostenotic and inflammatory pathways in IBD [spyre.com](https://www.spyre.com/pipeline)
- **SPY130 (IL-23 antibody)**: Phase 1/2 anti-IL-23 p19 antibody targeting a validated and highly successful mechanism in IBD [spyre.com](https://www.spyre.com/pipeline)
- **SPY002 (α4β7 + TL1A) and SPY003 (α4β7 + IL-23)**: Rational combination programs designed to deliver more complete disease control and greater durability than monotherapy

## Market Standing
- **Valuation/Market Cap**: Not explicitly stated; recent public offering raised substantial capital
- **Key Metric**: **Total Funding via Public Offering**: $463.5 million gross proceeds from a public offering and full exercise of underwriters’ option, announced May 1, 2026 (upsized from $403.0M) [ir.spyre.com](https://ir.spyre.com/overview)
- **Notable Investors/Partners**: The company is publicly traded; institutional and retail investors participated in the offering. Partnership and investor details are disclosed in SEC filings.
- **Growth Signals**:
  - Announced positive **SPY001 Part A Induction Results** on April 14, 2026, demonstrating proof-of-mechanism [ir.spyre.com](https://ir.spyre.com/overview)
  - Raised $463.5M in a single public offering in May 2026, signaling strong institutional confidence
  - Pipeline advancing into Phase 2 and Phase 3 programs across multiple antibody formats
  - Company is rapidly expanding its R&D and clinical capabilities

## Competitive Advantages
- **Rational Combination Strategy**: Spyre is one of the few companies pioneering concurrent targeting of α4β7 with TL1A or IL-23 in a single therapeutic program, potentially offering superior efficacy over single-target biologics
- **Extended Half-Life Antibody Engineering**: All pipeline antibodies are engineered for longer dosing intervals, which could improve patient adherence and convenience
- **100% Remote-First Model**: Operates a fully remote team with periodic in-person gatherings, allowing access to top talent across geographies without requiring relocation
- **Deeply Validated Biology**: All three primary targets (α4β7, TL1A, IL-23) are clinically validated in IBD, derisking the pipeline

## Strategic Focus
- Advance **SPY001** into Phase 3 trials for IBD
- Progress **SPY120** and **SPY130** through Phase 1/2 dose optimization and proof-of-concept studies
- Generate clinical data for the **rational combination programs (SPY002, SPY003)** to demonstrate additive/synergistic benefit
- Leverage the significant capital raise to expand clinical operations, manufacturing, and pipeline expansion

## Why Work Here
- **100% Remote-First Culture**: Spyre is fully remote with “frequent all team, in-person meetings to build relationships and problem solve” [job-boards.greenhouse.io](https://job-boards.greenhouse.io/spyretherapeutics)
- **Generous Time Off**: Unlimited PTO plus two one-week company-wide shutdowns each year
- **Competitive Compensation**: Market-competitive base salary, performance bonus, and equity grant opportunities
- **Comprehensive Benefits**: Health, welfare, and retirement benefits included
- **Fast-Paced Startup Environment**: Opportunities to “wear multiple hats, learn quickly, and help shape the culture of our young company”
- **Mission-Driven**: Direct impact on improving the lives of millions of IBD patients. The team is described as “collaborative and interdisciplinary” [spyre.com](https://www.spyre.com/careers)
- **Transparent and Accessible Leadership**: Company updates and financial results are shared regularly; recent events include public webcasts and presentations

## Sources
1. [spyre.com](https://www.spyre.com/)
2. [ir.spyre.com](https://ir.spyre.com/overview)
3. [job-boards.greenhouse.io](https://job-boards.greenhouse.io/spyretherapeutics)
4. [spyre.com/careers](https://www.spyre.com/careers)
5. [spyre.com/pipeline](https://www.spyre.com/pipeline)

## Other roles at Spyre Therapeutics

- [Executive Director, Clinical Operations](https://feeny.ai/job/executive-director-clinical-operations-spyre-therapeutics-united-states-p8kh871y1tyz) — United States
- [Senior Director, Biostatistics](https://feeny.ai/job/senior-director-biostatistics-spyre-therapeutics-united-states-t018pkc6s859) — United States
- [Senior Scientist, Translational Science](https://feeny.ai/job/senior-scientist-translational-science-spyre-therapeutics-united-states-2bxjq71x123q) — United States
- [Senior Director, Drug Safety and Pharmacovigilance Operations](https://feeny.ai/job/senior-director-drug-safety-and-pharmacovigilance-operations-spyre-therapeutics-8z5gh0007fj3) — United States
- [Associate Director, Clinical Supply Chain](https://feeny.ai/job/associate-director-clinical-supply-chain-spyre-therapeutics-united-states-bat1jhy7310w) — United States