Clinical Scientist, Clinical Development

The role

You will design, execute, and interpret clinical trials for novel antibody-based therapies. You will collaborate across functions to ensure robust study designs and high-quality data generation.

What you will do

• Collaborate with clinical operations, data management and CRO to identify data trends and ensure patient safety.
• Perform regular, systematic reviews of clinical trial data.
• Assist in Medical Monitor responsibilities.
• Contribute to study design and amendments.
• Collaborate with internal and external stakeholders on authoring and submission of protocols and regulatory filings.
• Assist with scientific oversight and decision-making support during trial execution.
• Write and review abstracts, posters, and content for scientific meetings and presentations.
• Write clinical science sections of meeting packages and assist in development of clinical documentation.
• Collaborate with regulatory affairs to ensure study designs meet regulatory standards.
• Develop and maintain clinical trial documentation.

Required qualifications

• 5+ years of clinical development experience in the biotech/pharma industry.
• 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.
• Excellent written and verbal communication skills, presentation and interpersonal skills.
• Bachelor's degree in life sciences, clinical pharmacology, immunology or related discipline.

Nice to have

• Advanced degree is a plus
• at least 2 years in immunology, gastroenterology/IBD or immune-mediated disease area

Benefits

• Market competitive compensation and benefits package
• Base salary
• Performance bonus
• Equity grant opportunities
• Health, welfare & retirement benefits
• Unlimited PTO
• Two, one-week company-wide shutdowns each
• Professional development opportunities

About the company

Spyre Therapeutics is a clinical-stage biotechnology company committed to developing next-generation therapies in immunology. Their pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, IL-23, and IL-17A/F.