Lead Clinical Research Scientist

About the Opportunity

This is an exciting opportunity to join our team at Daiichi Sankyo Inc. as a Clinical Science Program Manager. You will have the chance to lead clinical research initiatives and contribute to the development of innovative pharmaceutical therapies.

Key Responsibilities

• Study Strategy: You will develop biomarker strategies in collaboration with Translational Medicine and Clinical Pharmacology, and review patient population and protocol compliance for consistency with study strategy.
• Study Planning and Execution: You will oversee recruitment, retention, and establish contingency plans for shortfalls. You will interact with Key Opinion Leaders and Principal Investigators to plan studies and monitor completion.
• Study Outputs: You will draft responses to Institutional Review Boards and Health Authorities, collaborate with TMCP to ensure appropriate biomarker and PK/PD measurements, and review emerging clinical data regularly.
• External Collaboration: You will develop and lead external advisory panels to advise on Phase 2 study strategy, design, and conduct, and interact with KOLs for indication-specific advice.
• Scientific, Program-Related: You will create early development plans, contribute to overall development strategy, and interpret new preclinical/clinical data to inform Go/No Go decisions and reprioritization.
• Additional Non-Study-Related Activities: You will initiate contact with KOLs, prepare material for KOL interactions, and contribute to portfolio decisions.

Qualifications

Successful candidates will meet the qualifications below with or without a reasonable accommodation.

Education Qualifications: Master's Degree or equivalent preferred.

Experience Qualifications: 7 or More Years with PharmD, PhD, and relevant clinical experience preferred. 10 or More Years with Masters degree and relevant clinical experience preferred.

Travel: Ability to travel up to 30%. In-house office position that may require global travel.