- Location
- JPN - Osaka - Osaka Headquarters, Japan
- Type
- Full-time
- Department
- Healthcare
- Seniority
- Director
- Source
- Workday
Description
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Job Description
· Partner with MPD Global Project Management to coordinate R&D function support for assigned products within the GPT or PST or products under EPIC portfolio. Provide medical and clinical scientific leadership, expertise and execution for assigned products to support other R&D function leads within the team.
· Establish integrated partnership(s) with R&D functional leads on assigned team (regulatory affairs, pharmacovigilance, global development operations).
· Collaborates with the commercial organizations to achieve team objectives
· Form integrated partnerships and collaborate with all relevant cross-divisional stakeholders to support assigned products, including but not limited to, Quality, Global Manufacturing and Supply, Medical Affairs (Global and Regional), Global Commercial, LOC MDs, Regional Business Units (e.g., product brand leads) and LOC product leads.
· Forms integrated partnerships with and works with Global Product Team Leaders (GPL) and Global Project management (GPM) as necessary, and ensures excellence in delivery of medical and clinical support and execution of clinical development activities/studies across assigned products. Works effectively to support GPT/PSTs.
· Forms integrated partnership with strategic partner vendor(s) and provide oversight of all strategic partner vendor medical and clinical deliverables for assigned products. Ensure highest quality of medical/clinical science input and clinical components of deliverables from the strategic partner vendor.
· Partners with strategic partner vendor(s) and drives medical and clinical scientific activities relating to the preparation / approval of protocols and the conduct of clinical studies to support LCM, post marketing requirements and regional or local registration as needed. Provides Takeda oversight of strategic partner MDs/clinical staff involved in these activities. Accountable for the successful design, execution and interpretation of clinical studies.
· Oversees the strategic partner vendor(s) to ensure appropriate and continuous medical monitoring and medical data review of clinical studies, to ensure appropriate benefit/risk of subjects within the study. Responsible for internal oversight of strategic partner vendor medical monitoring activities, assessing issues related to protocol conduct and/or individual subject benefit/risk. Assesses overall safety information for studies and compound in conjunction with Pharmacovigilance. Makes final decisions regarding study conduct related to scientific integrity
· Establish integrated partnership with strategic partner clinical operations and statistical functional leads to ensure the integrity and correctness of data analysis and interpretation with the appropriate integration of safety and efficacy data from clinical studies longitudinally and cross-sectionally in support of regulatory submissions, ensuring data quality and adherence to national and international regulations and requirements and ICH.
· Participates in cross functional non-project-specific initiatives and committees on behalf of project clinical perspective
· Presents study conclusions to management and determine how individual study results impact the product strategy. Interprets data from an overall scientific and regulatory standpoint as well as within the context of the medical significance to individual patients
· Participate in and support all required regulatory submissions/interactions for assigned products. Represent Takeda as Responsible Medical Doctor and Medical/Clinical expert to regulatory agencies globally for assigned products as needed. Support Local Operating Company (LOC) medical staff for regulatory agency interactions for assigned products, as needed. Drive and execute medical and clinical scientific input and development of required documents for regulatory applications/submissions (e.g. briefing reports, CTDs, IND updates, PSUR updates, label changes etc.), materials used for meeting presentations, and formal responses to communications received from the regulatory agencies.
· Provide scientific education and mentoring for internal and external audiences (academic partners, scientific community)
· Oversee compliance with internal SOPs and external legal requirements, including training of assigned personnel, contractual arrangements with external service providers and partner companies.
· Lead the application of appropriate AI tools, internal digital platforms and new technological skills to enhance the efficiency of Clinical Science (CS) related activities. Explore and experiment with new ideas to stay ahead in the rapidly evolving field of technology, especially those most relevant to CS responsibilities. Collaborate closely with DD&T related functions to combine the clinical science expertise with new technology expertise in the organization to develop innovative approaches for rapid evaluation and reporting of clinical trial data to facilitate quick and robust decision making to bring value to patients and the organization.
Takeda Compensation and Benefits Summary:
Allowances: Commutation, Housing, Overtime Work etc.
Salary Increase: Annually, Bonus Payment: Twice a year
Working Hours: Headquarters (Osaka/ Tokyo) 9:00-17:30, Production Sites (Osaka/ Yamaguchi) 8:00-16:45, (Narita) 8:30-17:15, Research Site (Kanagawa) 9:00-17:45
Holidays: Saturdays, Sundays, National Holidays, May Day, Year-End Holidays etc. (approx. 123 days in a year)
Paid Leaves: Annual Paid Leave, Special Paid Leave, Sick Leave, Family Support Leave, Maternity Leave, Childcare Leave, Family Nursing Leave.
Flexible Work Styles: Flextime, Telework
Benefits: Social Insurance, Retirement and Corporate Pension, Employee Stock Ownership Program, etc.
Important Notice concerning working conditions:
It is possible the job scope may change at the company’s discretion.
It is possible the department and workplace may change at the company’s discretion.