At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.
Job Summary
Responsibilities
- Study Strategy: Under guidance of CSL and/or Medical Monitor, drafts development plan.
- Supports CSL and/or Medical Monitor in development of study design to meet study objectives.
- Contributes to provide strategic direction to Biostatistics and Data Operations (BDO) for EDC, edit checks, data quality listings, SAP, Data Mgmt plan and to Clinical Operations on SDV plan.
- Participates in the development of biomarker/PK strategy in collaboration with Translational Medicine and Clinical Pharmacology (TMCP).
- Provides input to the Integrated Data Review Plan process with Data Management. Performs literature review and creates reference list for study. Study Planning and Execution: Contributes to clinical trial planning including identification of potential risks to study deliverables and contingency planning.
- Supports development of protocol profile, protocol, and ICF template.
- Participates in the selection of ARO, CRO, and members for DSMB and/or adjudication committee and the 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), to Data Management on the Integrated Data Review Plan, and to Biostatistics on Statistical Analysis Plan (SAP).
- Reviews patient demographics, enrollment, retention and protocol compliance. Study outputs: 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: Participates in discussions with internal experts and external KOLs for protocol development.
- Participates in the review of CRO and ARO Scope of Work and budget.
- Participate in study team meetings with CRO and ARO.
- Contributes to establish effective communication with CRO, ARO, and vendors. Additional non-study related activities: Performs literature review related to new indications for Life Cycle Management.
Qualifications
Education Qualifications
- Bachelor's Degree in life sciences or related field required
- Master's Degree, PharmD, PhD or equivalent preferred
- Postgraduate training in TA or related specialty, or equivalent, preferred
Experience Qualifications
- 1-3 years of relevant clinical experience with advanced degree (PharmD, PhD) preferred
- 3 or more years of relevant clinical experience with Bachelor’s degree
- Technical Proficiency: Develop and demonstrate proficiency in necessary technical skills and tools.
- Be adept at preparing documentation and supporting materials for various clinical trial activities preferred
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
Salary Range:
USD$124,960.00 - USD$187,440.00