Clinical Scientist, Associate Director
$181,000–$194,000 year
On-siteNeedham, Massachusetts, United States
Job Summary
Conduct ongoing clinical data review and analysis to ensure data integrity, identify trends, and support safety and efficacy assessments for oncology programs. Perform medical monitoring activities, including adverse event reviews, protocol deviation analysis, and eligibility assessments. Author and contribute to clinical and regulatory documents such as Clinical Study Reports, Investigator Brochures, protocols, and regulatory submissions. Collaborate with Clinical Operations, Regulatory Affairs, and Biostatistics to deliver high-quality clinical programs while developing study synopses and statistical analysis plans. Ensure compliance with ICH GCP, FDA, and EMA regulations. This Associate Director role supports Candel's Phase 3 lead candidate in prostate cancer and solid tumor studies within a lean biotech environment.
Required Qualifications
- 5+ years of Clinical Scientist or related clinical development experience within biotechnology or pharmaceutical organizations
- Oncology clinical development experience
- 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
- Applicants must be legally authorized to work in the United States at the time of hire and throughout employment
Desired Qualifications
- experience supporting prostate cancer, lung cancer, brain cancer, or other solid tumor studies
- Experience supporting BLA preparation or regulatory filings
- Experience working within a small or mid-sized biotechnology company
- 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
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