Clinical Scientist

Candel TherapeuticsNeedham, MA
6d$175,000 - $190,000Hybrid

About The Position

Candel Therapeutics is seeking a highly motivated Clinical Scientist to support our oncology clinical development programs, with a focus on prostate cancer. This role will contribute to the design, execution, and documentation of clinical trials, including long-term studies. The ideal candidate will have hands-on experience in clinical data review, medical monitoring, and authoring key regulatory documents such as clinical study reports (CSRs), investigator brochures (IBs), and IND/IDE submissions.

Requirements

  • Advanced degree in life sciences or related field.
  • 5+ years of clinical research experience in biotech/pharma, preferably in oncology.
  • Demonstrated expertise in clinical data review and medical monitoring for long-term studies.
  • Strong background in authoring regulatory and clinical documents

Nice To Haves

  • Experience supporting prostate cancer studies or solid tumors is highly desirable.

Responsibilities

  • Perform ongoing clinical data review and analysis to ensure data integrity, identify trends, and support safety and efficacy assessments.
  • Support medical monitoring activities in oncology studies, including review of adverse events, protocol deviations, and long-term safety and efficacy outcomes.
  • Author and contribute to clinical documents including CSRs, IBs, protocols, ICFs, DSURs, and regulatory submissions.
  • Collaborate with cross-functional teams (clinical operations, regulatory, biostatistics, translational) to ensure alignment across clinical deliverables.
  • Participate in the development of study synopses, protocols, statistical analysis plans, and briefing documents for regulatory interactions.
  • Contribute to literature reviews, clinical evaluation reports, and scientific publications.
  • Ensure compliance with ICH GCP, FDA/EMA guidelines, and internal SOPs.
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