Associate Director, Clinical Science
3 weeks ago
Study Strategy:
Develops and implements the strategic direction for clinical trials, collaborating with Biostats, Data Management, and Data Operations to ensure EDC, edit checks, data quality listings, SAP, and Data Management plans are aligned with study objectives.
Study Planning and Execution:
Provides input on major milestones, clinical trial plans, and contingency planning, analyzing and updating management on potential risks to study deliverables.
Study Outputs:
Drafts responses to IRBs and Health Authorities, collaborating with Translational Medicine and Clinical Pharmacology to ensure appropriate biomarker, PK/PD measurements, and reviews emerging clinical data regularly.
External Collaboration:
Consults with internal experts and external KOLs, Ad Boards for protocol development, and provides input on CRO/ARO Statements of Work and Budget.
Qualifications:
Requires a Master's Degree or equivalent, with 4+ years of PharmD, PhD, and relevant clinical experience, or 7+ years with a Master's degree and relevant clinical experience.
Travel:
Ability to travel up to 30% for global in-house office position.
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer, committed to diversity and inclusion.
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