Senior Clinical Development Specialist
5 days ago
Dedicated to creating and supplying innovative pharmaceutical therapies, Daiichi Sankyo Group has a rich legacy of innovation and a robust pipeline of promising new medicines. With over 125 years of scientific expertise and a presence in more than 20 countries, the company is committed to improving standards of care and addressing diversified, unmet medical needs globally.
Job SummaryThe Senior Clinical Development Specialist will play a critical role in drafting development plans, protocol profiles, protocols, and clinical sections of submission documents under the guidance of CSL and/or Medical Monitor. This position provides essential support to the CSL and Medical Monitor in executing Clinical Development functions.
Key Responsibilities- Study Strategy: Drafts development plans under the guidance of CSL and/or Medical Monitor. Contributes to the development of study design to meet study objectives, biomarker/PK strategy, and data quality listings, providing strategic direction to Biostatistics and Data Operations (BDO) for EDC, SAP, and Data Management Plan. Performs literature reviews and creates reference lists for studies.
- Study Planning: Contributes to clinical trial planning, including identification of potential risks to study deliverables; development of contingency plans; selection of ARO, CRO, and members for DSMB and/or adjudication committees; development of charters for study committees. Provides input to Clinical Operations on monitoring plans and to Biostatistics on Statistical Analysis Plans (SAP).
- Study Execution: Reviews patient demographics, enrollment, retention, and protocol compliance for consistency with study strategy. Collaborates with lead statisticians on SAP updates and provides input to Clinical Operations on site issues.
- External Collaboration: Consults with internal experts and external KOLs for protocol development. Participates in study team meetings with CRO and ARO and establishes effective communication with CRO, ARO, and vendors.
This role requires:
- A 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
$120,000 - $180,000 per year, depending on experience and qualifications.
BenefitsDaiichi Sankyo, Inc. offers competitive benefits, including health insurance, retirement plans, and paid time off.
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