Director, Clinical Scientist

Responsibilities

• Develop and review clinical narratives.
• Monitor clinical data for specific trends.
• Support pharmacovigilance activities (e.g., contributing to aggregate reports, patient narratives).
• Assist in the development of site and CRA training materials.
• Deliver quality study strategy and design, including analysis and interpretation of data throughout the study.
• Review/query clinical trial data – monitor data quality for trends, and ensure appropriate quality measures are in place.
• Ensure consistency of study execution to facilitate data analysis and regulatory filing.
• Contribute to the development of end-to-end clinical development strategy.
• Contribute to the development of Statistical Analysis Plans, IND, Investigators’ Brochure, IRB responses, CSRs, and other study-related documents.
• Support regulatory interactions, including through briefing documents, presentations, questions, and responses.

Qualifications

• Advanced degree in Life Sciences with 10+ years of experience.
• Prior radiopharmaceutical experience a plus.
• Solid tumor study experience required.
• 6+ years as a Clinical Scientist or comparable role in Clinical Development, with a minimum of 2 years Sponsor experience.
• Working knowledge of GCP/ICH, drug development process, study design, statistics, and clinical operations.
• GCP/ICH experience, including writing and/or reviewing study protocols, procedures manuals, ICFs, and clinical study reports.
• Ability to understand assigned clinical protocol(s), their requirements, and support program-specific data review and trend identification.
• Strong project management capabilities with demonstrated ability to problem-solve and mediate complex issues.
• Outstanding written and oral communication skills for clinical, business, and scientific audiences.
• Strong sense of urgency and excellence in prioritization, planning, and execution.
• Strong interpersonal skills and ability to thrive in a matrix environment.
• Highly adept at solving complex, cross-functional problems.
• Effective verbal and written communication skills within and outside the company.
• Meticulous attention to detail, including the capacity to conduct thorough self-reviews.
• Highly organized, collaborative, and motivated in a fast-paced startup environment.
• Proven demonstration of transparent communication and fostering open and diverse debate.
• Ability to work with agility and manage ambiguity.
• Personifies positive energy and exemplifies respect.