Clinical Scientist
Candel Therapeutics
7 months ago
Remote friendly (Needham, MA)
United States
Clinical Research and Development
Remote role (Flexible schedule; must be open to coming to the Needham, MA office as needed)
Salary: $181,000–$194,000
Key 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 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.
Qualifications & Experience:
- Advanced degree in life sciences or related field.
- 5+ years of clinical research experience in biotech/pharma, preferably in oncology.
- Experience supporting prostate cancer studies or solid tumors (highly desirable).
- Demonstrated expertise in clinical data review and medical monitoring for long-term studies.
- Strong background in authoring regulatory and clinical documents.
Core Skills & Competencies:
- Deep understanding of oncology clinical trial design and execution.
- Proficiency in clinical data analysis and interpretation.
- Excellent medical writing and communication skills.
- Strong organizational skills and ability to manage multiple priorities.
- Familiarity with clinical trial databases, coding dictionaries (e.g., MedDRA), and safety reporting tools.
- Collaborative mindset and ability to work in a fast-paced, cross-functional environment.
Salary: $181,000–$194,000
Key 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 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.
Qualifications & Experience:
- Advanced degree in life sciences or related field.
- 5+ years of clinical research experience in biotech/pharma, preferably in oncology.
- Experience supporting prostate cancer studies or solid tumors (highly desirable).
- Demonstrated expertise in clinical data review and medical monitoring for long-term studies.
- Strong background in authoring regulatory and clinical documents.
Core Skills & Competencies:
- Deep understanding of oncology clinical trial design and execution.
- Proficiency in clinical data analysis and interpretation.
- Excellent medical writing and communication skills.
- Strong organizational skills and ability to manage multiple priorities.
- Familiarity with clinical trial databases, coding dictionaries (e.g., MedDRA), and safety reporting tools.
- Collaborative mindset and ability to work in a fast-paced, cross-functional environment.