Senior Director, Clinical Research Scientist (Hybrid) (Cambridge, MA)

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 Clients
This is a full time position