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

Remote Role: Flexible schedule with occasional travel to our Needham, MA headquarters as business needs require.

Salary: $181,000–$194,000

Why Work With Us

At Candel, our people drive our success. We value diversity, collaboration, and bold thinking in a supportive, mission-driven environment. Like a team, we show up for each other and stay 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 Immunotherapies

Candel 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.com

The Opportunity

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.

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, 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.

Qualifications & Experience

• 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.
• Experience supporting BLA preparation or regulatory filings is a plus.
• Experience working within a small or mid‑sized biotechnology company is preferred.

Core Skills & Competencies

• Passion for oncology science with genuine curiosity about clinical data and patient outcomes.
• Strong analytical mindset with the ability to critically evaluate clinical data, identify trends, and investigate complex scientific questions.
• Collaborative team player who enjoys working across multiple functions in a highly interactive environment.
• Adaptable, flexible, and comfortable supporting multiple clinical programs in a lean biotechnology company.
• Coachable, proactive, and eager to continuously learn and expand scientific knowledge.
• Excellent medical writing, presentation, and communication skills.
• Strong organizational and project management skills with the ability to balance multiple priorities.
• High attention to detail and commitment to scientific rigor, quality, and patient safety.
• Experience with clinical trial databases, MedDRA coding, safety reporting systems, and clinical data review tools is preferred.
• 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.