Spyre Therapeutics
Clinical Scientist, Clinical Development
US- Remote
Sponsorship not specified$215k-$230kDetected 7 days ago
GCPClinical TrialsPharmacologyFDA RegulatoryExperimental DesignCommunicationCollaborationPublic SpeakingRegulatory Affairs
About the role
- Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.
- The expected salary range offer for this role is $215,000 to $230,000.
- Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.
Responsibilities
- Lead/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.
- Provide 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.
- 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.).
Requirements
- 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
- Ideal Candidate:
Nice to have
- PhD, MD, PharmD or equivalent in life sciences, clinical pharmacology, immunology or related discipline is preferred
- alternatively, MSc plus significant industry experience.
- 5+ years (or more for senior levels) of clinical development experience in the biotech/pharma industry, ideally with at least 2 years in rheumatology, or other immune-mediated disease area.
- Demonstrated experience designing and executing clinical trials in rheumatology, or other I&I therapeutic area.
- Strong understanding of clinical biomarkers, PK/PD modelling, patient stratification and immunologic endpoints.
- 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.
Compensation
- Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.
- The expected salary range offer for this role is $215,000 to $230,000.
Benefits
- Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.
- Collaborate with clinical operations, data management and CRO to develop and implement the overall data quality plan and lead internal medical data review and safety trend analysis on one or more studies/programs.
Company info
- 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.
Equal opportunity
- As an equal opportunity employer, Spyre is committed to a diverse workforce.
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This listing is sourced directly from Spyre Therapeutics's careers page and normalized into a canonical job model.