Clinical Scientist - Oncology (Prostate Cancer Focus)

Position Overview

This remote position requires flexibility in schedule, with the availability to travel to our Needham, MA office as needed. The role offers a competitive salary ranging between $181,000 and $194,000 annually.

About Candel Therapeutics

Candel is a pioneering clinical-stage biopharma company dedicated to developing innovative off-the-shelf multimodal immunotherapies that elicit tailored, systemic anti-tumor responses. Our technology platforms leverage genetically engineered adenovirus and HSV constructs. With promising Phase 3 clinical outcomes for our leading candidate, we are poised to transform cancer treatment landscapes. Our company culture emphasizes diversity, teamwork, transparency, and accountability, fostering an environment of ownership, trust, and innovation to make significant patient impacts.

Role Responsibilities

• Conduct continual clinical data evaluations to maintain data accuracy, spot trends, and aid in assessing safety and effectiveness.
• Assist with medical monitoring activities in oncology clinical trials, notably reviewing adverse events, protocol deviations, and long-term efficacy and safety.
• Develop and contribute to critical clinical and regulatory documents, including clinical study reports (CSRs), investigator brochures (IBs), protocols, informed consent forms (ICFs), development safety update reports (DSURs), and IND/IDE submissions.
• Collaborate with interdisciplinary teams such as clinical operations, regulatory affairs, biostatistics, and translational research to synchronize clinical deliverables.
• Engage in creating study synopses, protocols, statistical analysis schemes, and prepare briefing materials for regulatory bodies.
• Support scientific literature reviews, produce clinical evaluation reports, and participate in the publication process.
• Ensure adherence to industry standards such as ICH GCP, FDA and EMA regulations, along with internal standard operating procedures.

Qualifications and Experience

• Possess an advanced degree in life sciences or a related discipline.
• Have at least five years of clinical research experience in biotech or pharmaceutical settings, with a preference for oncology-focused roles.
• Experience in prostate cancer or solid tumor clinical studies is highly valued.
• Proven expertise in clinical data analysis and medical oversight of prolonged studies.
• Strong background in drafting regulatory and clinical documentation.

Core Skills and Competencies

• Extensive knowledge of oncology clinical trial design and management.
• Competence in clinical data assessment and interpretation.
• Superior medical writing and communication abilities.
• Excellent organizational capabilities, adept at managing multiple responsibilities efficiently.
• Familiarity with clinical trial databases, medical coding systems like MedDRA, and safety reporting software.
• A collaborative and adaptable professional spirit suitable for dynamic, cross-functional teams.

Additional Information

Candidates must be legally eligible to work in the United States at the time of hire and throughout employment, as the company does not provide or sponsor work authorization or visas now or in the future.