Senior Director, Clinical Science
Senior Director, Clinical Science 1358047
Location: Boston, MA (Hybrid)
Science/ Focus: Genome Editing Systems – multiple disease states
Therapeutic Areas: Hematology/Oncology, Neurology, Immunology, Ophthalmology and Rare Disease/gene or cell therapy
Job Overview: Reporting to Head of Clinical Development, will drive the collection, review and analysis of clinical data for one or more complex compound programs.
- Ensure ongoing active review of clinical data for trends in safety, effectiveness, and adherence to protocol across clinical trial sites.
- Assist with safety monitoring including contribution to the Development Safety Update Report (DSUR), the Periodic Benefit Risk Evaluation Report (PBRER) and the Safety Risk Management Plan for assigned compounds.
- Drive the preparation of clinical documents for submission to global health authorities including briefing books/materials supporting EMA Scientific Advice, Pre-IND, IND, End-of-Phase II, NDAs, MAAs and other regulatory meetings and regulatory filings as required.
- Drive authorship of meeting abstracts and posters and the publication of clinical trial data in accord with the publication strategy for the clinical program.
- Develop in collaboration with Clinical Development team and CROs all clinical trial documents
- Advanced degree (PhD or PharmD) with 10+ years of experience in the Clinical Research & Development/Clinical Trials environment is required with a minimum of 2 years of clinical trial monitoring experience required.
- Experience in Hematology/Oncology, Neurology, Immunology, Ophthalmology and Rare Disease Drug Development preferred and familiarity with gene and/or cell therapy.
- Experience with all phases of clinical drug development including global regulatory submissions preferred.
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