Clinical Scientist, Associate Director

Candel Therapeutics•Needham, MA

2d•$181,000 - $194,000•Remote

About The Position

Candel Therapeutics is seeking an experienced and intellectually curious Clinical Scientist to support our oncology clinical development programs, with an initial focus on prostate cancer and opportunities to contribute across additional solid tumor programs, including lung and brain cancer studies. This role is ideal for someone who enjoys analyzing clinical data, asking scientific questions, solving complex problems, and working collaboratively in a lean biotech environment. You will play a key role in clinical trial execution, medical monitoring, data interpretation, regulatory documentation, and cross-functional collaboration while helping shape the future of our oncology programs. We're looking for someone who is excited by the science, thrives in a collaborative environment, and enjoys wearing multiple hats while contributing wherever needed.

Requirements

5+ years of Clinical Scientist or related clinical development experience within biotechnology or pharmaceutical organizations.
Oncology clinical development experience required; experience supporting prostate cancer, lung cancer, brain cancer, or other solid tumor studies is highly desirable.
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. We are unable to provide, assume, or sponsor employment visas now or in the future.

Nice To Haves

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.

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.