What are the responsibilities and job description for the Manager, Clinical Science position at Daiichi Sankyo, Inc.?
Join a Legacy of Innovation 125 Years and Counting!
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
- Study Strategy: Drafts development plan under guidance of CSL and/or Medical Monitor. Contributes along with CSL and/or Medical Monitor to development of study design to meet study objectives, development of biomarker/PK strategy in collaboration with Translational Medicine and Clinical Pharmacology (TMCP), providing strategic direction to Biostatistics and Data Operations (BDO) for EDC, edit checks, data quality listings, SAP, Data Mgmt plan, providing strategic direction to Clinical Operations on SDV plan. Performs literature review and creates reference list for study.
- Study Planning: Contributes to clinical trial planning including identification of potential risks to study deliverables; development of contingency plan; development of protocol profile, protocol, and ICF template; selection of ARO, CRO, and members for DSMB and/or adjudication committee; development of charters for study committees (e.g., Executive Committee). Provides input to Clinical Operations on monitoring plan (e.g. data fields to be SDV’d) and to Biostatistics on Statistical Analysis Plan (SAP).
- 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. Provides input to Clinical Operations on site issues. Contributes to development of CSR.
- 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. Meets with commercial group regarding new indications for Life Cycle Management.
- Additional non-study related activities: Clinical Development involvement in due diligence activities related to in-licensing and acquisitions. Performs literature review related to new indications for Life Cycle Management.
Education Qualifications (from an accredited college or university)
- Master's Degree or equivalent preferred
- PharmD or equivalent preferred
- PhD or equivalent preferred
- Postgraduate training in TA or related specialty, or equivalent preferred
- 1 or More Years with PharmD, PhD and relevant clinical experience preferred
- 4 or More Years with Master’s degree and relevant clinical experience preferred
