Senior Director, Clinical Research Scientist (Hybrid)

Summary: This role is ideal for someone with a strong background in clinical research and drug development. The position involves shaping and driving the clinical development process, contributing to clinical program strategy and execution, and working closely with cross-functional teams to ensure the successful design and delivery of clinical studies. The ideal candidate will bring expertise in regulatory standards, data analysis, and clinical development within a fast-paced environment.Responsibilities:Shape and drive the clinical development process, including strategy, design, and execution.Assess the competitive and global regulatory landscape, develop endpoints, and optimize data management.Collaborate with the clinical development team to design clinical studies.Develop presentations and communicate study data results to internal and external audiences, including investigators and scientific conferences.Author and review clinical study documents in compliance with regulatory standards (protocols, informed consent documents, investigator brochures, INDs, NDAs).Provide clinical input on case report form (CRF) design, statistical analysis plans, and drug supply planning.Perform and coordinate clinical data review and analysis of study results.Monitor efficacy and safety data, taking appropriate actions as needed.Prepare clinical content for regulatory submissions and documents, including Investigator’s Brochure (IB) and Development Safety Update Report (DSUR).Conduct regular reviews of individual subject safety data and document findings.Prepare abstracts, posters, presentations, and publications.Assist in arranging investigator meetings, scientific advisory boards, Data Monitoring Committees, and steering committees.Requirements:Advanced degree (Ph.D., PharmD, or Master’s) in a scientific field.At least 8 years of experience in pharmaceutical or biotechnology clinical research.Comprehensive understanding of all stages of drug development.Clinical development experience in oncology is preferred.Thorough knowledge of FDA, GCP, ICH, and eCTD compliance standards and relevant regulatory requirements.Strong ability to interpret clinical data and prepare regulatory submissions.Demonstrated ability to review, summarize, and present study data.Analytical and strategic thinking skills, with a proven ability to contribute to clinical strategies and development plans.Strong written and oral communication skills with the ability to collaborate across disciplines.Department: Direct ClientsThis is a full time position