Description:
The Senior Clinical Scientist will contribute to the scientific, clinical, and operational scope of assigned study protocols. This role will work with the cross-functional teams for the design, execution, and monitoring of clinical studies, as well as assist with data review, interpretation, and communication to both internal and external stakeholders.
- Contribute to clinical development strategy and execution of the Clinical Development Plan (CDP) with a focus on early-phase development.
- Partner with cross-functional teams with oversight from senior team members to conduct clinical studies, including study start up, execution and close out activities, data review/analysis, and preparation of study reports.
- Contribute to the development of program-level documents, including but not limited to clinical protocols, investigator’s brochure, clinical study reports, abstracts and manuscripts, presentations, and various other internal and external documents and communications as needed.
- Conduct ongoing data reviews; prepare and present summaries to internal and external stakeholders.
- Ensure trial implementation according to the protocol and analyze information to assess issues relating to protocol conduct and/or individual subject safety.
- Interact with internal and external stakeholders (investigators, study sites, vendors, committees, etc.) in support of clinical trial objectives; responds to or triages questions for appropriate escalation.
- Conduct literature reviews as needed.
- Travel: Up to 20%.
Required Experience, Skills, and Education:
- BS/BA or master’s degree in a scientific discipline, or other relevant advanced degree in a health science field.
- Minimum 4 years of experience in the pharmaceutical or biotechnology industry as a clinical scientist or related role.
- Thrives in a collaborative team setting and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment.
- Detail-oriented with ability prioritize tasks and function independently as appropriate.
- Strong organizational skills and an ability to interpret, discuss, and report trial/program level data effectively and identify trends.
- Proficient with software tools (Microsoft Office), Electronic Data Capture, and other custom web-based software.
- Excellent written and verbal communication skills.