Sanofi
biopharma
ClinicalResearchDirector
“Clinical Research Director at Sanofi. Skills: clinical trial strategy, clinical development plan, clinical development and studies activities, clinical interpretation of study results, regulatory and safety documents and discussions, scientific data evaluation and authorship. Leads clinical trial strategy of assigned program(s) within the clinical development team. Establishes or adapts clinical development plan for the program(s)”
What You'll Achieve.
drive breakthroughs that could turn the impossible into possible for millions; achieve project milestones
Industry & Context.
plans contingencies
What They're Looking For.
Must Have
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
What You'll Do.
Leads clinical trial strategy of assigned program(s) within the clinical development team
Establishes or adapts clinical development plan for the program(s)
supports and oversees the execution of clinical development and studies activities
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
Participates and contributes to regulatory and safety documents and discussions
Authors clinical abstracts
presentations for conferences
Supports the planning of advisory board meeting
Presents and discusses development strategy and clinical study result with external investigators and advisory boards
How You'll Work.
Team & Collaboration
interactions with Clinical Operations, Biostatistics, Regulatory, Translational Medicine, Project Management, New Product Planning and Pharmacovigilance; work with a multifunctional team to achieve project milestones; Provides effective clinical guidance to other functions, including Clinical Operations, Biostatistics and Translational Medicine
Communication Scope
interactions with clinical investigators, advisors and regulatory authorities; Provides effective clinical guidance to other functions; Participates in Advisory Committee preparation; Presents and discusses development strategy and clinical study result with external investigators and advisory boards
Process & Methodology
clinical development plan, execution of clinical development and studies activities
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