Clinical Scientist

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 in oncology studies, including review of adverse events, protocol deviations, and long-term safety and efficacy outcomes.
• Author and contribute to clinical documents including CSRs, IBs, protocols, ICFs, DSURs, and regulatory submissions.
• Collaborate with cross-functional teams (clinical operations, regulatory, biostatistics, translational) to ensure alignment across clinical deliverables.
• Participate in the development of study synopses, protocols, statistical analysis plans, and briefing documents for regulatory interactions.
• Contribute to literature reviews, clinical evaluation reports, and scientific publications.
• Ensure compliance with ICH GCP, FDA/EMA guidelines, and internal SOPs.

Qualifications & Experience

• Advanced degree in life sciences or related field.
• 5+ years of clinical research experience in biotech/pharma, preferably in oncology.
• Experience supporting prostate cancer studies or solid tumors is highly desirable.
• Demonstrated expertise in clinical data review and medical monitoring for long-term studies.
• Strong background in authoring regulatory and clinical documents.

Core Skills & Competencies

• Deep understanding of oncology clinical trial design and execution.
• Proficiency in clinical data analysis and interpretation.
• Excellent medical writing and communication skills.
• Strong organizational skills and ability to manage multiple priorities.
• Familiarity with clinical trial databases, coding dictionaries (e.g., MedDRA), and safety reporting tools.
• Collaborative mindset and ability to work in a fast-paced, cross-functional environment.