Clinical Scientist, Clinical Development

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

Benefits offered by this job

Unlimited PTO

Equity grant opportunities

Health, welfare & retirement benefits

Remote work environment

Job summary

Spyre Therapeutics is a clinical-stage biotechnology company focused on immunology therapies. As a Clinical Scientist you will design, execute, and interpret clinical trials, collaborating across operations, regulatory, translational science, and biomarker teams to ensure robust study designs and high-quality data.

You will contribute to regulatory submissions, safety oversight, and medical monitoring support, while maintaining scientific rigor and alignment with FDA/ICH and GCP standards in a

Qualifications

• 5+ years in biotech/pharma clinical development
• Experience in immunology or GI/IBD preferred
• Familiar with FDA/ICH and GCP guidelines

Responsibilities

• Design, execute, and interpret clinical trials.
• Collaborate across clinical ops, regulatory, translational science, and biomarkers.
• Ensure data integrity, safety, and scientific validity of data.
• Develop regulatory submissions and protocol amendments.
• Assist with Medical Monitor responsibilities and trial oversight.
• Monitor trial metrics, site initiation, and close-out activities.

Skills

Clinical development

Immunology

Regulatory compliance

Cross-functional collaboration

Communication skills

Education

Bachelor's degree in life sciences

Advanced degree preferred

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:

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 disab