Senior Clinical Research Scientist

2 weeks ago


Cambridge Massachusetts, United States Bicycle Therapeutics Full time
Job Summary

Bicycle Therapeutics is seeking a highly motivated and experienced Clinical Scientist (Associate Director) to provide scientific support for all clinical development activities involving the conduct of clinical studies. This role will sit within the clinical department, working to advance Bicycle Toxin Conjugates and Bicycle Immune Agonists as novel cancer therapeutics.

Key Responsibilities
  • Design and conduct clinical studies for the development of novel tumor antigen-targeted Bicycle therapeutics.
  • Participate in the strategy, design, authoring, and review of clinical documents, including protocols, amendments, informed consent forms, clinical study reports, investigator brochures, drug safety update reports, and clinical development plans.
  • Lead medical and safety data review and associated meetings in collaboration with the Medical Monitor, review and query data.
  • Participate in study start-up, including identification of investigators/sites, feasibility, review of CRF, etc.
  • Develop content and give presentations during site initiation visits; participate in site training.
  • Serve as a liaison between the study team, CROs, and investigators.
  • Track study progress and metrics related to emerging clinical data.
  • Contribute to regulatory documents, including INDs and briefing books and other regulatory documents.
  • Enable translational medicine by working closely with biomarker and discovery scientists.
  • Perform literature searches and critically review and summarize results to support activities such as document development, new indications for a given molecule, and competitive intelligence.
  • Contribute to publication strategy and provide support for publication of data.
  • Assist in preparing material for advisory boards, conference activities, external collaborations, and partnerships.
  • Support internal initiatives to develop best practices, lessons-learned, problem-solving, and risk mitigation.
  • Potential to mentor other clinical scientists.
  • Attend congresses as needed to support publications as well as interactions with key opinion leaders and investigators.
Requirements

The ideal candidate will have a strong background in oncology or immunology and experience in clinical development. They will be able to work effectively in a team environment and communicate complex scientific information to both technical and non-technical stakeholders.



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