Clinical Scientist, Clinical Development

About Spyre Therapeutics

Spyre Therapeutics is a clinical-stage biotech company focused on pioneering next-generation immunology therapies. Their pipeline features investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23, aiming to provide enhanced disease control, longer durability, and simpler treatments for patients.

Role Summary

We seek a Director, Clinical Scientist to design, implement, and analyze clinical studies advancing Spyre's novel antibody therapies in rheumatic and other immune-inflammatory disorders. This role demands collaboration across clinical operations, regulatory affairs, translational science, and biomarker teams to ensure study rigor, high-quality data, and program progression. The position acts as a vital link between internal partners, external investigators, and CROs.

Key Responsibilities

• Lead or contribute to protocol design and amendments in consultation with internal and external stakeholders.
• Partner with Clinical Development, regulatory, and others to author and submit protocols, amendments, regulatory filings, and documents.
• Coordinate with clinical operations, data management, and CROs to establish and implement data quality plans, lead medical data review, and conduct safety trend analyses across studies.
• Collaborate with translational science and biomarker teams to incorporate mechanistic biomarkers, PK/PD modeling, patient stratification, and exploratory endpoints.
• Provide scientific oversight during trial execution including site selection, study start-up, monitoring of key metrics, risk-based quality control, and study closure.
• Interpret clinical results (safety, efficacy, biomarkers, PK/PD) and present findings internally and externally at scientific meetings and publications.
• Prepare and review scientific content such as abstracts, posters, presentations, and coordinate internal reviews.
• Draft clinical science materials for meeting packages and review regulatory documents.
• Ensure study designs comply with regulatory standards (FDA/ICH, GCP) and support regulatory submissions and communication.
• Maintain clinical trial documentation including protocols, clinical study reports, investigator brochures, and informed consent forms.
• Monitor competitive and scientific landscapes to aid strategic positioning of programs.
• Undertake additional duties as assigned.

Ideal Candidate Profile

• PhD, MD, PharmD or equivalent in life sciences, clinical pharmacology, immunology, or related fields preferred; alternatively, MSc with extensive industry experience.
• Minimum 5 years biotech/pharma clinical development experience, with at least 2 years focused on rheumatology or immune-mediated diseases.
• Proven record designing and conducting clinical trials in rheumatology or I&I areas.
• Deep knowledge of clinical biomarkers, PK/PD modeling, patient stratification, and immunologic endpoints.
• Familiarity with regulatory and Good Clinical Practice guidelines (FDA/ICH, GCP).
• Strong ability to collaborate cross-functionally within matrix organizations.
• Excellent communication, presentation, and interpersonal skills with the ability to influence diverse groups.
• Thrives in dynamic, fast-paced environments with changing priorities and roles.

Benefits and Working Environment

• Engage in a dynamic, evolving workplace shaping company culture and advancing impactful medicines.
• Competitive compensation including base salary, performance bonuses, equity, and comprehensive health and retirement benefits.
• Unlimited paid time off with two annual one-week company-wide shutdowns.
• Professional development opportunities to enhance skills and careers.
• Remote work flexibility combined with periodic in-person meetings to tackle complex challenges and foster relationships.

Additional Information

The anticipated salary range is $215,000 to $230,000, varying based on experience, qualifications, and location. Spyre Therapeutics is an equal opportunity employer committed to diversity and inclusion across all aspects of employment, prohibiting discrimination on any non-job-related characteristics. Candidates are reminded that official Spyre recruiters only use corporate email addresses ending in '@spyre.com' and never request purchases or sensitive information. Job postings are available exclusively on the company's careers webpage.