Associate Director Clinical Science
2 weeks ago
About Daiichi Sankyo, Inc.
Daiichi Sankyo, Inc. is a global pharmaceutical innovator dedicated to creating and supplying innovative therapies to improve standards of care and address unmet medical needs. With a rich legacy of innovation and a robust pipeline of promising new medicines, we are committed to delivering value to our stakeholders and making a meaningful difference in people's lives.
Job Summary
We are seeking an experienced Associate Director, Clinical Science to join our team. This role will oversee a single non-pivotal trial, preparing the clinical section of regulatory documents, collaborating with AROs/CROs, and providing medical and/or scientific direction to Clinical Operations. The successful candidate will have a strong background in clinical science, excellent communication skills, and the ability to travel up to 30%.
Responsibilities
- Study Strategy
- Develops biomarker strategy in collaboration with Translational Medicine/Clinical Pharmacology
- Reviews patient population and protocol compliance for consistency with study strategy
- Provides input on major milestones of trial, clinical trial plan, and contingency planning
- Study Planning and Execution
- Oversees recruitment and retention
- Establishes and implements contingency plans for shortfalls
- Consults & recruits members for DSMB and/or adjudication committee setup
- Study Outputs
- Drafts responses to IRBs and Health Authorities
- Reviews emerging clinical data regularly
- Leads dose-escalation meetings
- External Collaboration
- Consults with internal experts and external KOLs, Ad Boards for protocol development
- Provides input on CRO/ARO Statement of Work and Budget
- Additional Non-Study Related Activities
- Occasional senior management interactions at FIHC, WDC
- Initiates contact w/KOL and prepares material for KOL interactions on a program based need
Qualifications
Successful candidates will have a Master's Degree or equivalent, PharmD or equivalent, PhD or equivalent, and postgraduate training in TA or related specialty. They will also have 4 or more years of relevant clinical experience or 7 or more years with a Master's degree and relevant clinical experience.
Travel
Ability to travel up to 30%. In-house office position that may require travel (global).
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