Clinical Development Team Lead
3 days ago
Company Overview
">Daiichi Sankyo, Inc. is a leading pharmaceutical company dedicated to improving patient outcomes through innovative therapies.
">About Us
">We have over 125 years of scientific expertise and a presence in more than 20 countries, with a strong portfolio of medicines for cardiovascular diseases and a robust pipeline of promising new medicines in oncology.
">Job Summary
">This role provides critical support to the Clinical Development team, drafting development plans, protocol profiles, protocols, and clinical sections of submission documents under the guidance of CSL and/or Medical Monitor.
">Responsibilities
">- ">
- Study Strategy: Develops study plans under the guidance of CSL and/or Medical Monitor, contributes to study design, and provides strategic direction to Biostatistics and Data Operations (BDO) for EDC, edit checks, data quality listings, SAP, Data Management plan, and provides input to Clinical Operations on SDV plan.">
- Study Planning: Contributes to clinical trial planning, including identifying potential risks to study deliverables; develops contingency plans; selects ARO, CRO, and members for DSMB and/or adjudication committee; and develops charters for study committees (e.g., Executive Committee).">
- Study Execution: Reviews patient demographics, enrollment, retention, and protocol compliance for consistency with study strategy; reviews emerging clinical data regularly; performs quality assessment of Tables/Listings/Graphs before database lock; collaborates with lead statistician on SAP update, as needed; and provides input to Clinical Operations on site issues.">
- External Collaboration: Consults with internal experts and external KOLs for protocol development; provides input on CRO and ARO Scope of Work and budget; participates in study team meetings with CRO and ARO; establishes effective communication with CRO, ARO, and vendors; and meets with commercial group regarding new indications for Life Cycle Management.">
Qualifications
">Successful candidates will hold a Master's Degree or equivalent, PharmD or equivalent, PhD or equivalent, or Postgraduate training in TA or related specialty, or equivalent, with 1 or More Years of relevant clinical experience preferred or 4 or More Years with master's degree and relevant clinical experience preferred.
">Salary Range
">$120,000 - $180,000 per annum based on location and qualifications.
">Benefits
">We offer a competitive salary range, comprehensive benefits package, and opportunities for professional growth and development.
">Equal Employment Opportunity
">Daiichi Sankyo, Inc. is an equal opportunity employer and welcomes applications from diverse candidates.
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