Associate Director Clinical Science
1 day ago
Company: Daiichi Sankyo Inc.
Job Type: Full-time
Location: Global
About the RoleThe Associate Director, Clinical Science will oversee a single non-pivotal trial, preparing the clinical section of regulatory documents and collaborating with AROs/CROs. This role will provide medical and/or scientific direction to Clinical Operations and represent Clinical Development on Project Teams.
Responsibilities- Study Strategy: Develops biomarker strategy in collaboration with Translational Medicine/Clinical Pharmacology and provides strategic direction to Biostats Data Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, and Data Mgmt plan.
- Study Planning and Execution: Provides input on major milestones of trial, clinical trial plan, and contingency planning, and analyzes and updates management on potential risks to study deliverables.
- Study Outputs: Drafts responses to IRBs and Health Authorities, collaborates with Translational Medicine and Clinical Pharmacology to ensure appropriate biomarker, PK/PD measurements, and reviews emerging clinical data regularly.
- External Collaboration: Consults with internal experts and external KOLs, Ad Boards for protocol development, and provides input on CRO/ARO Statement of Work and Budget.
- Additional Non-Study Related Activities: Occasional senior management interactions at FIHC, WDC, and involvement with in-licensing and acquisitions on individual due diligence activities.
Successful candidates will meet the qualifications below with or without a reasonable accommodation.
- Education Qualifications: Master's Degree or equivalent preferred, or PharmD or equivalent preferred, or PhD or equivalent preferred, or Postgraduate training in TA or related specialty, or equivalent preferred.
- Experience Qualifications: 4 or More Years with PharmD, PhD, and relevant clinical experience preferred, or 7 or More Years with Master's degree and relevant clinical experience preferred.
Ability to travel up to 30%. In-house office position that may require travel (global).
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.
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