Remote Oncology Clinical Scientist | Associate Director

Candel Therapeutics; Needham (MA); Remote; USD 181,000 - 194,000; Full time

Job summary

Candel Therapeutics is seeking a Clinical Scientist to support oncology clinical development, with focus on prostate cancer and other solid tumors. You will perform data reviews, medical monitoring, and regulatory document authorship in a lean biotech setting.

Ideal candidates bring 5+ years in oncology clinical development, hands-on data review, and strong medical writing skills, with collaboration across Clinical Operations, Regulatory, Biostatistics, and Medical Writing.

Qualifications

• 5+ years of clinical scientist or related clinical development experience.
• Oncology clinical development experience required; prostate, lung, brain cancer or other solid tumors desirable.
• Hands-on experience with clinical data review and medical monitoring.
• Experience authoring clinical/regulatory documents (CSRs, IBs, protocols, DSURs, IND submissions).
• Experience supporting BLA preparation or regulatory filings is a plus.
• Experience in a small or mid-sized biotechnology company is preferred.

Responsibilities

• Perform ongoing clinical data review to ensure data integrity, identify trends, and support safety and efficacy assessments.
• Support medical monitoring activities, including review of adverse events, eligibility assessments, and long-term safety outcomes.
• Author and contribute to CSR, IBs, protocols, ICFs, DSURs, and regulatory submissions.
• Collaborate with Clinical Operations, Regulatory Affairs, Biostatistics, Data Management, Medical Writing, and Pharmacovigilance.
• Develop study synopses, protocols, statistical analysis plans, briefing books, and regulatory responses.
• Review and interpret clinical data to identify trends and provide insights to study teams.
• Contribute to literature reviews, abstracts, manuscripts, and scientific publications.
• Support multiple oncology programs as priorities evolve.
• Help establish and improve clinical development processes within a fast-growing biotech.
• Ensure compliance with ICH GCP, FDA, EMA, SOPs and industry standards.

Skills

Oncology clinical development

Clinical data review

Medical monitoring

Medical writing

Cross-functional collaboration

ICH GCP knowledge

Tools

MedDRA coding

Clinical data review tools

Job description

Candel Therapeutics is seeking a Clinical Scientist to support oncology clinical development, with focus on prostate cancer and other solid tumors. You will perform data reviews, medical monitoring, and regulatory document authorship in a lean biotech setting.

Ideal candidates bring 5+ years in oncology clinical development, hands-on data review, and strong medical writing skills, with collaboration across Clinical Operations, Regulatory, Biostatistics, and Medical Writing.