Clinical Study Lead
Tokyo 23 Wards
Permanent
¥8,000,000 - ¥10,000,000
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Contribute to an CNS/Neurology Specialized Biopharmaceutical Company
Lead Global Studies without Drug Lag
About Our Client
- US headquartered global biopharmaceutical company specialising in CNS, Neuroscience and Immunology TAs
- Ranked within the top 20 biopharmaceutical companies globally in terms of annual revenue
- Broad pipeline consisting of gene therapy, biotherapeutics, small molecular therapies
Job Description
- Deliver and execute clinical studies in Japan
- Provide input into study start up activities (e.g. study feasibility, study specifications, vendor/partner contracts, authoring of clinical study protocols and budgeting including authorisation and governance of payment).
- Oversee deliver of plan of studies performed through external partners (such as Alliance partners, CROs, vendors and Academic Research Organizations)
- Monitor progress, identify and solve operational issues
- Lead and manage all activities related to site management and monitoring including the following with agreed time lines, agreed budget and company standard quality
- Plan and deliver site selection strategy
- Patient recruitment strategy including SMO managements
- Lead and manage CRAs including CRO CRAs to deliver clinical study data
The Successful Applicant
- University degree, preferably in medical or biological sciences or discipline associated with clinical research. Advanced degree is preferred
- Experience in pharmaceutical industry or relative academic experience
- Extensive knowledge of clinical operations, project management tools and processes
- Good experience of clinical development / drug development process in various phases of development and therapy areas.
- Knowledge of process improvement methodology
- Evidence of developing partnering skills
- Native level Japanese
- Business level English
What's on Offer
- Lead and manage clinical operations for Japan R&D
- Contribute to oncology portfolio of leading global pharmaceutical company
- Good work/life balance
- Opportunity to work on global projects