Manager overseeing Project Management team in Clinical Research at Sanford Health. Collaborating with Clinical Research Managers and guiding strategic research initiatives.
About the role
- Clinical Research Director at Sanofi managing clinical trial strategy in oncology development. Overseeing execution of clinical development and collaborating with multifunctional teams.
Responsibilities
- Establishes or adapts clinical development plan for the program(s) including discussions with clinical investigators, advisors and regulatory authorities and plans contingencies.
- Leads, supports and oversees the execution of clinical development and studies activities, including but not limiting to: Authors abbreviated protocol.
- Reviews the final protocol and protocol amendments.
- Reviews the Informed Consent Form, Written Subject Information and Trial Disclosure Form.
- Reviews the study specific committee charters.
- Leads study specific committees with operational support.
- Leads the clinical interpretation of study results, contributes to clinical study reports and clinical summaries.
- Provides effective clinical guidance to other functions, including Clinical Operations, Biostatistics and Translational Medicine.
- Participates and contributes to regulatory and safety documents and discussions.
- Reviews and/or contributes clinical sections of the Investigator Brochure, IND/IMPD filings, DSUR, development risk management plans.
- Contributes to the clinical sections of the NDA/CTD, Briefing packages for regulatory meetings, PSP/PIP.
- Participates in Advisory Committee preparation.
- Scientific data evaluation and authorship. Authors clinical abstracts, presentations for conferences, and manuscripts, when appropriate.
- Supports the planning of advisory board meeting. Presents and discusses development strategy and clinical study result with external investigators and advisory boards, as appropriate.
Requirements
- MD degree or equivalent, with Medical Oncology fellowship
- Hematology/Oncology fellowship or experience (4+ years) in Oncology Development
- Expertise in pharmaceutical medicine based on industry experience (3+ years) or academic clinical research experience (3+ years)
- Experience in clinical development, late-stage preferred
- Demonstrated ability to interact productively with external investigators
- Demonstrated ability to work with a multifunctional team to achieve project milestones
- Understanding of and willingness to meet applicable regulatory, quality and compliance standards.
Benefits
- high-quality healthcare
- prevention and wellness programs
- at least 14 weeks’ gender-neutral parental leave
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