Clinical Scientist

Candel Therapeutics • Full-time • Needham, MA, US • 4m ago

Clinical ScientistCandel Therapeutics | Needham, MA (Hybrid)
Salary: $175-$190,000Why Work With UsAt Candel, our people drive our success. We value diversity, collaboration, and bold thinking in a supportive, mission-driven environment. We are a high-performing team that shows up for each other and stays focused on making a difference for patients and families. Our leadership is transparent and empowering, and our culture is built on trust, flexibility, and accountability, encouraging ownership and innovation every day.Our Science: Advancing Cancer ImmunotherapiesCandel is a clinical-stage biopharma company developing off-the-shelf, multimodal immunotherapies that stimulate personalized, systemic anti-tumor responses. Our platforms use genetically modified adenovirus and HSV constructs. With positive Phase 3 results for our lead candidate, it’s an exciting time to join us and help bring transformative cancer treatments to patients. Learn more: www.candeltx.comThe OpportunityCandel 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.
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 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.

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 is 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.

Applicants must be legally authorized to work in the United States at the time of hire and throughout employment. We are unable to provide, assume, or sponsor work visas or employment authorization for this role now or in the future.