Clinical Scientist, Clinical Development

Spyre Therapeutics; United States; Remote; USD 175,000 - 205,000; Full time

Benefits offered by this job

Unlimited PTO

Company-wide shutdowns

Remote work with occasional in-person

Professional development opportunities

Job summary

Spyre Therapeutics is seeking a Clinical Scientist, Clinical Development to design, execute, and interpret clinical trials for their antibody therapies. The role requires collaboration across clinical operations, regulatory, translational science, and biomarker teams to ensure robust study designs and high-quality data.

You will help drive program progression while maintaining regulatory compliance and scientific integrity.

Qualifications

• 5+ years of clinical development experience in biotech/pharma.
• Experience in immunology or immune-mediated diseases.
• Bachelor's degree in life sciences; advanced degree is a plus.
• Familiarity with FDA/ICH, GCP.

Responsibilities

• Collaborate with clinical operations, data management and CRO to ensure patient safety and protocol compliance.
• Regularly review clinical trial data, including adverse events and lab data.
• Assist in Medical Monitor responsibilities.
• Contribute to study design and amendments with stakeholders.
• Author regulatory documents and review protocols and amendments.
• Support trial execution with site selection, start-up, monitoring and quality oversight.
• Prepare and review abstracts, posters and presentations for scientific meetings.

Skills

Cross-functional collaboration

Regulatory knowledge

Scientific writing

Study design

Data interpretation

Education

Bachelor's degree in life sciences or related

Job description

Clinical Scientist, Clinical Development

US- Remote

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 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.

I certify that Spyre Therapeutics may collect and process my personal information as I provide it and pursuant to the terms of Spyre Therapeutic’s “Candidate Privacy Statement”, which is available here for my review Privacy Policy. .
I further certify that the information I provide herein is accurate and that Spyre Therapeutics or its designee(s) may process it.