Pliant Therapeutics is a public, clinical stage biopharmaceutical company focused on the discovery and development of novel therapies for fibrotic diseases. Founded by Third Rock Ventures with world-renowned academic thought leaders, Pliant is raising the bar to meet the unmet medical needs of physicians, patients and families impacted by fibrotic disease. The Company’s focus is on mechanism-based intervention in the fibrotic process using small molecules. The Company’s lead product candidate, PLN-74809, is an oral, small molecule selective inhibitor of the αvβ1 and αvβ6 integrins that play a key role in multiple fibrotic pathways. PLN-74809 has received Orphan Drug Designation from the U.S. Food and Drug Administration in both idiopathic pulmonary fibrosis (IPF) and primary sclerosing cholangitis (PSC), and are currently in Phase 2a clinical trials for these indications. Pliant’s second product candidate, PLN-1474, is an oral, small molecule selective inhibitor of the αvβ1 integrin, in development as a potential treatment forlate-stage liver fibrosis under a partnership with Novartis. The Company also has discovery and development programs in oncology and muscular dystrophies. The Company is seeking passionate, creative, and dedicated individuals to join our team and contribute to our mission.

Responsibilities

  • Collaborate with a cross-functional team on the development of regulatory and nonclinical/clinical documents (e.g., protocols, investigator brochures, clinical study reports, INDs, eCTD clinical/nonclinical summaries, briefing books)
  • Ensure smooth and effective document management from template to a final approved version, which may include, but is not limited to: first draft authoring, reference retrieval, generating bibliographies, editing (e.g., follow house style guide), and managing various processes (e.g., reviews, QC, QA, formatting, publishing, document archiving)
  • Review, edit, and ensure quality of documents or sections of documents prepared by functional area representatives as required and ensure adherence to standards
  • Distill large amounts of clinical and scientific data into essential elements for graphical display
  • Oversee document review and comment resolution meetings with cross-functional teams
  • Formulate key messages from clinical and nonclinical study data
  • Perform literature-based research to support writing activities
  • Develop best practices for authoring and reviewing
  • Develop templates and outlines for regulatory documents

Qualifications

  • Bachelor’s degree in a scientific discipline required, advanced degree preferred
  • Minimum of 5 years of relevant pharmaceutical or biopharmaceutical industry experience
  • Demonstrated experience in medical writing, editing, and clinical development has written protocols, IBs and CSRs
  • Familiar with eCTD structure, and experience with eCTD summary documents (e.g. Modules 2.5 and 2.7) and/or regulatory briefing document
  • Strong leadership, planning and project management skills, along with initiative and ability of be productive with minimal supervision and support
  • Excellent oral and written communication skills
  • Flexible and adaptive work style to meet organization needs
  • Working knowledge of FDA, EMA and ICH regulatory guidance and regulations

 

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