Clinical Scientist, Clinical Development

Spyre Therapeutics

8h • $175,000 - $205,000 • Remote

About The Position

Spyre Therapeutics is a clinical-stage biotechnology company developing next-generation immunology therapies intended to provide more complete disease control, greater durability, and a simpler treatment experience. Its investigational pipeline includes extended half-life antibodies targeting α4β7, TL1A, IL-23, and IL-17A/F, as well as rational combination programs.

The Clinical Scientist plays a key role in designing, executing, and interpreting clinical trials supporting the development of novel antibody-based therapies. The role works across clinical operations, regulatory, translational science, biomarker teams, and other functions to support robust study design, high-quality data, and efficient program progression. The Clinical Scientist also connects internal teams with external investigators and CRO partners, while supporting the integrity, safety, and scientific validity of clinical study data.

Requirements

• At least 5 years of clinical development experience in the biotech or pharmaceutical industry.
• Bachelor's degree in life sciences, clinical pharmacology, immunology, or a related discipline.
• Demonstrated experience executing clinical trials in IBD or another I&I therapeutic area.
• Understanding of clinical biomarkers, PK/PD modeling, patient stratification, and immunologic endpoints.
• Familiarity with regulatory requirements, including FDA/ICH guidelines and Good Clinical Practice.
• Ability to work cross-functionally in a matrix organization, including with clinical operations, translational science, regulatory, and quality assurance teams.
• Excellent written and verbal communication, presentation, and interpersonal skills, with the ability to influence diverse stakeholders.
• Comfort working in a fast-paced, dynamic environment with ambiguity and willingness to take on multiple roles.

Nice To Haves

• At least 2 years of experience in immunology, gastroenterology/IBD, or an immune-mediated disease area.
• An advanced degree.

Responsibilities

• Collaborate with clinical operations, data management, and CRO partners on ongoing clinical data review; identify data trends, resolve discrepancies, and support patient safety and protocol compliance.
• Conduct regular, systematic reviews of clinical trial data, including adverse events, laboratory data, concomitant medications, medical histories, and clinical data query resolution.
• Assist with Medical Monitor responsibilities.
• Contribute to study design and protocol amendments with internal and external stakeholders.
• Collaborate with Clinical Development, regulatory, and other partners on authoring and submitting protocols, protocol amendments, regulatory filings, and other regulatory documentation.
• Support scientific oversight and decision-making during trial execution, including site selection, study start-up, monitoring key trial metrics, risk-based quality oversight, and study close-out.
• Write or review abstracts, posters, scientific meeting and conference content, presentations, and other publicly distributed materials, and coordinate reviews with internal partners and stakeholders.
• Write clinical science sections of meeting packages and assist with developing and reviewing clinical documentation for regulatory submissions and processes.
• Collaborate with Regulatory Affairs to ensure study designs meet regulatory standards, including FDA/ICH and GCP requirements, and support regulatory submissions and interactions.
• Develop and maintain clinical trial documentation, including protocols, clinical study reports, investigator brochures, and informed-consent forms.
• Monitor the competitive and scientific landscape in the therapeutics space and contribute to strategic positioning of Spyre's pipeline programs.
• Perform additional duties as assigned.

Benefits

• Market-competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, and health, welfare, and retirement benefits.
• Unlimited PTO.
• Two one-week company-wide shutdowns each year.
• Professional development opportunities.
• Remote working environment with frequent in-person meetings.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level