C

Celea Therapeutics

Clinical-stage biopharma developing deupirfenidone for IPF

Clinical Scientist - Director

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timeBoston, MA, USA

About the Job

Requirements

  • A PhD, PharmD, MS, or advanced scientific degree in a relevant discipline.
  • At least 8 years of relevant experience in clinical development, clinical research, or a related pharmaceutical or biotechnology environment.
  • Experience supporting clinical trials in a biotechnology or pharmaceutical company, including reviewing, aggregating, and synthesizing blinded safety data; troubleshooting missing data and assessments; and reviewing risk-based monitoring output.
  • Experience working directly with contract research organizations and other external clinical development partners.
  • Understanding of clinical trial methodology, clinical development processes, and Good Clinical Practice principles.
  • Strong scientific writing and communication skills.
  • Excellent organizational and project-management skills.
  • An entrepreneurial mindset and comfort operating in a fast-paced, early-stage environment.
  • Proficiency using artificial intelligence tools to improve the quality and speed of work.

Responsibilities

  • Support the development and execution of clinical development strategies and plans.
  • Contribute to clinical study design and implementation, including developing 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 in real time and through 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 contract research organization clinical teams to support study planning, execution, and delivery.
  • Review and provide input on contract research organization deliverables, including study plans, protocols, data review materials, and clinical reports.
  • Help identify and escalate study issues and work collaboratively with contract research organization partners to develop solutions.

Desired Qualifications

  • Respiratory disease area experience.
  • Experience with Phase 1–3 clinical development.
  • Experience supporting regulatory submissions or interactions.
  • Experience working with external investigators.

About the Company

Celea Therapeutics

Clinical-stage biopharma developing deupirfenidone for IPF

Celea Therapeutics develops and advances treatments for severe respiratory diseases, focusing on late-stage development of deupirfenidone (LYT-100), a deuterated form of pirfenidone. Its lead program targets idiopathic pulmonary fibrosis (IPF) and other fibrotic lung diseases and is prepared for Phase 3 trials. Deupirfenidone aims to slow lung function decline and improve tolerability by changing how the drug is processed in the body, potentially offering advantages over current IPF therapies. The company pursues a Phase 3 head-to-head trial (SURPASS-IPF) against an approved therapy, supported by Orphan Drug Designations and funding from investors, with PureTech Health retaining a meaningful stake.

Company size
11-50
Company stage
Growth Equity (Non-Venture Capital)
Total funding
$180M
Headquarters
Boston, MA
Founded
Not listed

Recently Posted Jobs

Explore more opportunities at Celea Therapeutics

See more jobs