Simmy O.
Associate Director, Senior Clinical Scientist- Oncology at Bristol Myers Squibb
- Role
- Associate Director, Senior Clinical Scientist (Lung Oncology Solid Tumors at Bristol Myers Squibb
- Location
- New York, NY, US
- LinkedIn followers
- 500 followers
About Simmy O.
Clinical development professional with knowledge and experience in areas of clinical…
Experience
Associate Director, Senior Clinical Scientist (Lung Oncology Solid Tumors
Jul 2020 — Present · US
Responsible for implementation, planning, and execution of assigned clinical trial activities.• Successfully leads, plans, and executes trial level activities for multiple trials• Co-Leads study team meetings in partnership with GDO protocol manager; and collaborate with cross functional study team members• Support clinical development planning (collaboration with Clinical Development Lead/Clinical Trial Physician for provision and analysis of data to support future planning)• Maintain a thorough understanding of assigned protocols and protocol requirements; educate supporting team members• Plan and lead the implementation all study startup/conduct/close-out activities as applicable• Evaluate innovative trial designs (collaboration with Medical Monitor/Clinical Development Lead)• Protocol and ICF development process; including writing, reviewing, adjudication/resolution of cross functional comments and ensuring high clinical quality (collaboration with Medical Writing)• Site-facing activities such as training and serving as primary contact for clinical questions• Activities related to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent, quality data review by supporting CS team• Clinical data trend identification: provide trends and escalate questions to Medical Monitor were needed.• Develop clinical narrative plan; review clinical narratives• Provision of information required by Protocol Manager for development of trial budget, CRO scope of work, etc.• Review development of site and CRA training materials and presentation at SIV and Investigator meetings and support on Study committee (e.g, DMC) activities• Drafting/review and validation of clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g, IB, DSUR, regulatory responses)• Collaborate and serve as primary liaison between external partners for scientific advice
Education
Weill Cornell Graduate School of Medical Sciences
Clinical and Transitional Science Program- Career Enhancement Track
2014 — 2014
City University of New York-College of Staten Island
Bachelor's Degree
2007 — 2011
State University of New York Downstate Medical Center College of Medicine
Master's Degree (MPH)
2014 — 2016
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