Elizabeth Hanson
- Role
- Associate Scientific Director at Takeda
- Location
- Chicago, IL, US
- LinkedIn followers
- 500 followers
Experience
Associate Scientific Director
Apr 2013 — Present
Develop tactical clinical plan and study designs to support the global development and establish the conditions essential for determining the safety, efficacy, medical usefulness, and marketability of CNS compounds - Develop clinical synopsis in collaboration with other members of the clinical team- Protocol development and scientific oversight of clinical development programs in CNS - Participate in development of Statistical Analysis Plan, Medical Monitoring Plan and other clinical trial-related documents- Provide responses to regulatory authorities in collaboration with Medical Monitor and Regulatory Affairs team members- Provide input on trial executional issues as needed- Provide training to CRAs and other site personnel internal team members on therapeutic area, appropriate subject selection and mitigating placebo response- Review aspects of the study execution and determine if any modification is required to maintain quality control- Review clinical data for meaningful trends to support improvements in trial design and execution for future CNS trials.
Skills
- Clinical Monitoring
- Clinical Research
- Regulatory Submissions
- Clinical Development
- Therapeutic Areas
- Gcp
- Regulatory Affairs
- Sop
- Pharmaceutical Industry
- Clinical Data Management
- Drug Development
- Clinical Trials
- CRO
- Ich-Gcp
- Edc
- Protocol
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