Director, Clinical Scientist
Spyre Therapeutics
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $215,000 - $230,000 per year
Job Level
Lead
Tech Stack
Google Cloud Platform
About the role
- 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.
- 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.
- Work closely with translational science to integrate mechanistic biomarkers, PK/PD modelling, patient stratification, and exploratory endpoints.
- 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.
- Interpret clinical data (safety, efficacy, biomarker, PK/PD) and present findings internally and externally (investigators, scientific meetings, publications).
- 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.
Requirements
- PhD, MD, PharmD or equivalent in life sciences, clinical pharmacology, immunology or related discipline is preferred; alternatively, MSc plus significant industry experience.
- 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.
- Demonstrated experience designing and executing clinical trials IBD or other I&I therapeutic area.
- Strong 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.
Benefits
- 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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical trial designclinical data interpretationPK/PD modellingbiomarker analysisdata quality plan developmentregulatory documentation authoringclinical study report writinginvestigator brochure developmentinformed consent form creationsafety trend analysis
Soft skills
cross-functional collaborationcommunication skillspresentation skillsinterpersonal skillsinfluencing stakeholdersdecision-making supportadaptabilityorganizational skillsteam leadershipproblem-solving
Certifications
PhDMDPharmDMScGood Clinical Practice (GCP) certification