- Lead Clinical Development Programs for Cardiovascular and Metabolic Diseases
- Drive R&D Strategic Planning and Execution across the Company
About Our Client
- Leading pharmaceutical company globally.
- Developing drugs across the following therapeutic areas: Oncology, Infectious Diseases and Vaccines, Immunology, Cardiovascular and Metabolism.
- Responsible for planning/execution/reporting of clinical studies and health authority interactions on clinical matters.
- Maintain high quality of clinical documentation sufficient to obtain regulatory approval by reviewing documents generated by Japan clinical science team
- Responsible for talent development of other Japan Clinical Development members
- Leads primary publication of clinical study data
- Responsibilities for health authority interaction
- Develops clinical section of Briefing Book for PMDA consultation(s)
- Develops clinical section of Common Technical Document (CTD)
- Generates responses to clinical inquiries from health authorities
- Supports PMDA inspection on clinical matters.
- Supports development of Risk Management Plan and J-package insert
- Accountability for clinical data
- Accountable for interpretation of all clinical data in assigned indication(s) and compound(s)
- Presents scientific and clinical information, and leads clinical discussions with internal/external stakeholders including health authorities
The Successful Applicant
- Medical or Life Sciences degree or equivalent qualification
- Experience in managing or leading global or multi-country project
- Experience in project management and/or team leadership, functional line management in one or more of the Pharmaceutical functions.
- Ability to respond flexibly to changing project priorities and work assignments.
What's on Offer
- Excellent career development opportunities
- Competitive salary package and benefits
- Strong pipeline including: Oncology, Infectious Diseases and Vaccines, Immunology, Cardiovascular and Metabolism.