We are seeking a Full Time Associate Clinical Scientist to join our team! You will give the opportunity to work on multiple clinical research projects and sponsor meetings.

Responsibilities:

• Perform literature searches and critically review and summarize the relevant scientific, drug development and medical literature to support document development, such as the investigator brochure, protocol design, clinical study report, etc.
• Identify and review literature that addresses specific topics of interest relevant to drug candidates
• Author clinical trial documents including but not limited to protocols, charters, safety monitoring plans, IND reports, process documents, meeting presentations, publications, and clinical sections of regulatory documents such as INDs, briefing books, clinical study reports, investigator brochures, annual reports and updates, and clinical sections of regulatory submissions to support product approvals.
• Prepare communication of study results internal/external (Abstracts, publications, posters)
• Participate to the development plan under project director supervision including looking for additional indications and competition survey
• Participate in the preparation of regulatory documents within his/her perimeter (e.g. Briefing book for Health Authorities meetings, periodic reports DSUR, PSUR and investigator brochures, PIP, Orphan, Drug Designation (ODD), if applicable
• Maintain awareness and keep program team informed of internal and external developments that may impact the investigational agent Clinical Development Plan, including attendance at major scientific conferences, participation in competitive intelligence activities, and periodic literature review.
• Maintain current knowledge of the external environment to ensure scientific innovations are considered and/or incorporated into clinical trial development strategy.
• Participate in development of the long-range strategic plans for the assigned program(s).
• Other assigned activities but not limited to the above

​Qualifications:

• Candidates should have an advanced clinical/science degree (e.g., Pharm. D., PhD, MSN, MPH, etc.).
• Experience in the analysis and interpretation of clinical data and assessment of clinical relevance
• Comprehensive understanding of clinical research and experience across Phase I – III drug development projects and comprehensive understanding of safety profiles and risks
• Ability to work independently and to organize priorities and deliverables.

Contact BBCR Today to Apply:

Phone: +1(617) 401-2327
Email: [email protected]/bbcr2