Note: The job is a remote job and is open to candidates in USA. Candel Therapeutics is a clinical-stage biopharma company focused on developing innovative cancer immunotherapies. The Clinical Scientist, Associate Director will support oncology clinical development programs, with a primary focus on prostate cancer, while also contributing to other solid tumor studies through data analysis, medical monitoring, and regulatory documentation.
Responsibilities
- Perform ongoing clinical data review and analysis to ensure data integrity, identify trends, and support safety and efficacy assessments
- Support medical monitoring activities, including review of adverse events, protocol deviations, eligibility assessments, and long-term safety and efficacy outcomes
- Author and contribute to key clinical and regulatory documents including Clinical Study Reports (CSRs), Investigator Brochures (IBs), protocols, informed consent forms (ICFs), DSURs, clinical narratives, and IND/BLA regulatory submissions
- Collaborate closely with Clinical Operations, Regulatory Affairs, Translational Medicine, Biostatistics, Data Management, Medical Writing, and Pharmacovigilance to deliver high-quality clinical programs
- Participate in the development of study synopses, protocols, statistical analysis plans, briefing books, regulatory responses, and scientific presentations
- Review and interpret clinical data to identify trends, investigate unexpected findings, and provide meaningful scientific insights to study teams
- Contribute to literature reviews, clinical evaluation reports, abstracts, manuscripts, and scientific publications
- Support multiple oncology programs as business priorities evolve, serving as a collaborative scientific partner across studies
- Help establish and continuously improve clinical development processes within a fast-growing biotechnology company
- Ensure compliance with ICH GCP, FDA and EMA regulations, company SOPs, and applicable industry standards
Skills
- 5+ years of Clinical Scientist or related clinical development experience within biotechnology or pharmaceutical organizations
- Oncology clinical development experience required
- Hands-on experience with clinical data review and medical monitoring
- Experience authoring clinical and regulatory documents including CSRs, Investigator Brochures, protocols, DSURs, IND submissions, and related regulatory documentation
- Thorough understanding of oncology clinical trial design, execution, Good Clinical Practice (ICH GCP), FDA regulations, and global clinical development
- Applicants must be legally authorized to work in the United States at the time of hire and throughout employment
- Experience supporting prostate cancer, lung cancer, brain cancer, or other solid tumor studies is highly desirable
- Experience supporting BLA preparation or regulatory filings is a plus
- Experience working within a small or mid-sized biotechnology company is preferred
- Experience with clinical trial databases, MedDRA coding, safety reporting systems, and clinical data review tools is preferred
Benefits
- Remote Role: Flexible schedule with occasional travel to our Needham, MA headquarters as business needs require.
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