Clinical Scientist, Director
Boston, MA, United States1w ago
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Skills
About the role
About Celea Therapeutics
Celea Therapeutics is dedicated to advancing transformative treatments for people with serious respiratory diseases. Drawn from the Latin word for “sky,” our name reflects our mission to rise above the status quo and deliver therapies that change lives. Our lead program, deupirfenidone (LYT-100), is currently in Phase 3 clinical development with active candidate enrollment, representing a potential new standard of care for idiopathic pulmonary fibrosis (IPF) and other fibrotic lung diseases.
Rising above the status quo takes a team as strong as its science, and we hire and work by five values: accountability — owning outcomes and acting like owners; transparency — talking straight and building trust; collaboration — achieving together what no one could alone; innovation — challenging accepted ideas and taking smart risks; and passion — bringing energy and heart to the mission.
As we prepare for our next stage of growth and clinical advancement, Celea is a highly motivated and collaborative Clinical Scientist to join the clinical development team. Reporting to the VP, Head of Clinical Development, this role will work closely with Clinical Development, Clinical Operations, Medical Affairs, and external partners to support the planning, execution, and interpretation of clinical studies. A key component of the role will be working closely with our CRO partners, helping to ensure high-quality study execution, timely delivery of clinical data, and alignment with the clinical development strategy.
This position is based in Boston, remote/hybrid friendly.
The ideal candidate is scientifically rigorous, highly organized, comfortable working in a fast-paced environment, and able to operate effectively with both internal stakeholders and external vendors.
Key Responsibilities
- Support the development and execution of clinical development strategies and plans.
- Contribute to clinical study design and implementation, including development of study concepts, protocols, schedules of assessments, medical monitoring plans and related clinical documents including investigator and site training materials.
- Conduct ongoing review and interpretation of clinical safety data and identify emerging trends, issues, and opportunities both in real-time and for aggregate review.
- Support clinical data review, including review of listings, tables, and figures.
- Partner with Clinical Operations and Data Management to identify and resolve data quality issues.
- Contribute to clinical study reports, regulatory documents, presentations, and other clinical development deliverables.
- Work closely with CRO clinical teams to support study planning, execution, and delivery.
- Review and provide input on CRO deliverables, including study plans, protocols, data review materials, and clinical reports.
- Help identify and escalate study issues and work collaboratively with CRO partners to develop solutions.
Qualifications
Required
- PhD, PharmD, MS or advanced scientific degree in a relevant discipline.
- 8+ years of relevant experience in clinical development, clinical research, or a related pharmaceutical/biotechnology environment.
- Experience supporting clinical trials in a biotechnology or pharmaceutical company including reviewing, aggregating and synthesizing blinded safety data and troubleshooting missing data and assessments, and reviewing risk-based monitoring output
- Experience working directly with CROs and other external clinical development partners.
- Understanding of clinical trial methodology, clinical development processes, and GCP principles.
- Strong scientific writing and communication skills.
- Excellent organizational and project-management skills.
- Entrepreneurial mindset and comfort operating in a fast-paced, early-stage environment.
- Proficiency using AI tools to work smarter — curiosity about how technology can improve the quality and speed of your work.
Preferred
- Respiratory disease area experience is preferred.
- Experience with Phase 1–3 clinical development.
- Experience supporting regulatory submissions or interactions.
- Experience working with external investigators.
Why Join Celea Therapeutics