Ellen Shen
- Role
- Director Project Management at Gilead Sciences
- Location
- San Mateo, CA, US
- LinkedIn followers
- 500 followers
About Ellen Shen
More than 10 years of experience in clinical development and post-approval setting, in a…
Experience
Director Project Management
Oct 2015 — Present
Currently leading Research Operations to support the Research organization-Provide assistance with contracts/agreements -Support those who write nonclinical documents for regulatory submissions -Manage and archive Research governance materials. Coordinate deliverables for Clinical Virology and ensuring good communication and teamwork with other functional areas. Manage relationship with external vendor and collaborator. Facilitate biomarker subteam and nonclinical subteam meetings, decision making and communication- Work closely with Clinical Virology to develop acceptable timelines for virology analyses and statistical datasets toward global regulatory submissions (NDAs, sNDAs, MAAs, Type 2 Variations, etc.)- Monitor timelines, proactively identify risks and foster cross-functional communication- Effectively negotiate and ensure tactical plan is aligned with timelines and regulatory submission goals- In partnership with the Nonclincal Lead, ensure execution of nonclinical strategy in accordance with governance processes- Facilitate subteam meetings and actively help the team identify and work through issues and achieve objectives- Manage direct report who ensures nonclinical regulatory documents meet regulatory submission standards and are managed in document management system. Also guide or support implementation of new processes and initiatives- Supported Biomarker Lead to manage execution of strategy; manage biomarker subteam meetings and facilitate cross-functional alignment for deliverables- Managed joint project team meetings with a startup company (external collaborator): work with Project Leader to develop agenda topics, build trustworthy relationship with external company, create and manage timelines, and track deliverables and action items- Therapeutic Areas: Virology, Emerging Viruses, Inflammation, Oncology.
Skills
- Oncology
- Biotechnology
- Gcp
- Clinical Trials
- Drug Development
- Clinical Development
- Ind
- Fda
- Clinical Research
- Regulatory Affairs
- Regulatory Submissions
- Pharmaceutical Industry
- Sop
- Life Sciences
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