The Clinical Research Scientist role will work within the Clinical Development Team and have opportunities to make
Reporting Relationship: Vice President, Research and Development
- Contributes to and/or lead the design of clinical studies in close collaboration with the Clinical Development Team.
- Collaborates on the review, analysis, and interpretation of study results, including exploratory endpoints and assuring appropriate data review and accurate data reporting.
- Provides scientific support by interpreting safety and efficacy results data, including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations.
- Contributes to database lock, statistical analysis plans, and preparation of Clinical Study Reports and other clinical documents.
- Assists in writing and providing scientific input, review, and edits of clinical study reports, Investigator Brochures,
INDs, NDA annual reports, integrated medical reports, and other regulatory submissions.
- Provides support for advisory boards, consultant meetings, and investigator meetings, including preparation and/or delivery of presentations.
- Minimum of 3 to 5
yearsclinical development experience in the pharmaceutical/biotech industry (clinical science, clinical operations, medical writing, etc.).
PhDin a related life science discipline.
- Comprehensive understanding of the drug development process from Phase 1 to Phase 3.
- Prior oncology drug development experience preferred.
Job Location: Cambridge, MA
Please send resumes to email@example.com