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: As a Clinical Scientist at Spyre Therapeutics, you will play a key role in designing, executing, and interpreting clinical trials that support development of our novel antibody-based therapies. You will collaborate across functions (clinical operations, regulatory, translational science, biomarker teams) to ensure robust study designs, high-quality data generation and efficient progression of programs. You will bring scientific and operational expertise and act as a bridge between internal teams, external investigators and CRO partners. You will ensure the integrity, safety, and scientific validity of data collected during clinical studies. Key Responsibilities: - Collaborate with clinical operations, data management and CRO, with a focus on ongoing clinical data review, to identify data trends, clean discrepancies, and ensure patient safety and protocol compliance. - Perform regular, systematic reviews of clinical trial data, including adverse events, lab data, concomitant medications, medical histories and resolution of clinical data queries. - Assist in Medical Monitor responsibilities. - Contribute to study design and amendments in collaboration with internal and external stakeholders. - Collaborate with Clinical Development, regulatory and other internal partners/stakeholders with authoring and submission of protocols, protocol amendments, regulatory filings, and other regulatory documentation. - Assist with scientific oversight and decision-making support during trial execution: site selection, study start-up, monitoring of key trial metrics, risk-based quality oversight and study close-out. - Write and/or review abstracts, posters, content for scientific meetings, conferences, other events and presentations, and other publicly distributed materials and coordinate further reviews with internal partners and stakeholders. - Write clinical science sections of meeting packages and assist in the development and review of other clinical documentation required for regulatory submissions and other regulatory processes - Collaborate with regulatory affairs to ensure study designs meet regulatory standards (e.g., FDA/ICH, GCP) and support regulatory submissions and interactions. - Develop and maintain clinical trial documentation (protocols, clinical study reports, investigator brochures, informed-consent forms, etc.). - Monitor the competitive and scientific landscape in therapeutics space and contribute to strategic positioning of Spyre’s pipeline programs. - Additional duties as assigned. Ideal Candidate: - 5+ years of clinical development experience in the biotech/pharma industry, ideally with at least 2 years in immunology, gastroenterology/IBD or immune-mediated disease area. - Bachelor's degree in life sciences, clinical pharmacology, immunology or related discipline; advanced degree is a plus. - Demonstrated experience in executing clinical trials IBD or other I&I therapeutic area. - An understanding of clinical biomarkers, PK/PD modelling, patient stratification and immunologic endpoints. - Familiarity with regulatory requirements (FDA/ICH guidelines, GCP) and Good Clinical Practice. - Proven ability to work cross-functionally in a matrix organization (clinical operations, translational science, regulatory, QA). - Excellent written and verbal communication skills, presentation and interpersonal skills; ability to influence diverse stakeholders. - Comfortable working in a fast-paced, dynamic environment with ambiguity, and willing to wear multiple hats. 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 $175,000 to $205,000. 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...