Associate Director Clinical Research Scientist – Oncology

Associate Director Clinical Research Scientist – Oncology

Requirements

• Minimum of a bachelor’s degree in a scientific discipline or health-related field required, with advanced degree (i.e., MSc, MPH, Ph.D., or Pharm D) preferred.
• At least 5 years of drug development experience in a related clinical research position and at least part of the time within the pharmaceutical/biotech industry is required.
• Experience conducting trials in hematologic oncology is required with strong preference for experience with clinical trials for leukemia.
• Strong understanding of Good Clinical Practices (ICH/GCP), the drug development process, and the design and conduct of clinical trials.
• Fluent in written and spoken English with excellent oral and written communication skills
• Ability to critically review, synthesize and present data.
• Ability to interact with associates at all levels to coordinate and execute study activities in a fast-paced small biotech environment.
• High performing and energetic individual with a passion for and dedication to clinical research and advancement of potential new treatments for patients.

Responsibilities

• Supports study-responsible physician (SRP) and/or lead junior clinical research scientist in execution of clinical trials.
• Participates in and leads aspects of protocol training for site initiation and investigator meetings in collaboration with clinical operations.
• Reviews and adjudicates study subject eligibility and protocol deviations and responds to specific site protocol questions, working closely with the SRP and/or lead clinical research scientist.
• Identifies scientific and/or clinical quality issues to discuss with investigator and study sites and escalates as appropriate to the quality team to ensure compliance with Good Clinical Practice (GCP).
• Collaborates effectively with internal cross-functional teams and external CRO partners to ensure the successful achievement of study goals, including meeting enrollment milestones and generating high-quality data.
• Actively participates in or leads the development of Clinical Study Protocols and Protocol Amendments, Informed Consent Forms, Investigator Brochures, Development Safety Update Reports, Clinical Study Reports, Safety Review Committee charters, study plans (e.g., Medical Data Review, Medical Monitoring, Cohort Management, Protocol Deviation Plans) and publications in collaboration with the SRP and/or lead clinical scientist.
• Assists in the development and finalization of clinical content for Health Authority and IRB/EC responses.
• Collaborates with lead clinical scientists, SRP, biometrics, pharmacovigilance and data management to plan and execute the analysis of clinical data.
• Conducts ongoing review of clinical data and performs critical analysis in partnership with lead clinical scientist, SRP, and data management, ensuring data integrity throughout the study.
• Identifies emerging data trends, communicates and discusses trends with SRP and pharmacovigilance scientist, when appropriate.
• Provides clinical insight to develop or update electronic case report forms (eCRFs), eCRF completion guidelines, Interactive Response Technology (IRT) specifications, patient profiles, and statistical analysis plans.
• Collaborates cross functionally to ensure that all clinical trial activities, data, and documentation adhere to regulatory guidelines, ethical standards, and internal processes.
• Ensures that clinical trial sites, documents, and data are always audit-ready. This includes maintaining thorough, organized documentation and ensuring that any findings from internal or external audits or otherwise are addressed promptly.
• Supports regulatory interactions by providing clear, accurate, and comprehensive data and documents for review, demonstrating adherence to compliance standards.

Preferred Qualifications

• Advanced degree (i.e., MSc, MPH, Ph.D., or Pharm D) preferred.