- Location
- JPN - Osaka - Osaka Headquarters, Japan
- Type
- Full-time
- Department
- Healthcare
- Seniority
- Entry
- Education
- Master
- Source
- Workday
Description
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Job Description
OBJECTIVES/PURPOSE:
- Leads and drives strategy for the overall global clinical development taking into consideration the medical, scientific, regulatory and commercial issues for multiple pipeline compounds.
- Applies clinical/medical decision making to clinical development issues.
- Influences senior leadership decision-making by setting strategic direction as well as by advocating for, designing, aligning, piloting and establishing new development processes that require cross-functional collaboration within Takeda R&D.
- Success or failure directly translates to the ability to meet its corporate goals and for Takeda to have future commercial products.
- Lead a multidisciplinary team (ie GCL). In this context knowledge, expertise needs to go beyond clinical and disease-area expertise to include broader areas of drug development (working knowledge of CMC, Commercial, etc.).
- Oversees medical monitor or clinical programs.
- Will have leadership of multidisciplinary clinical sub teams.
ACCOUNTABILITIES:
Clinical Development team participation and leadership
- Leads the Global Development Team (US, EU, Japan) managing both the US/EU Development Team and the Japan Development team for assigned compounds. In some cases may lead the US/EU Development Team but more likely will oversee the clinical scientist responsible for leading this team. Emphasis will be on insuring that the development teams are proactively identifying contingencies, potential risks and strategies to address future obstacles.
- Directs Development Team strategy and deliverables overseeing the Development Strategy, Clinical Development Plan and Clinical Protocols. Recommends scope, complexity and size, which influence the budget of all aspects of a program. Provides continual critical evaluation of the development strategy to maintain a state-of-the-art development plan that is competitive and consistent with the latest regulatory requirements, proactive identification of challenges, and development of contingency plans to meet them.
- Responsible for high impact local decisions: monitoring and interpreting data from ongoing internal and external studies, assessing the medical and scientific implications and making recommendations that impact local development such as “go/no go” decisions or modification of development plans or study designs that may have a significant impact on timelines or product labeling. Plans clinical development strategies in context of medical/clinical significance considering how a given product will fit in with current treatments, standard of care, and unmet medical need. A significant error in judgment may result in loss of approvability and/or commercial viability of a product.
Synopsis / Protocol Development, Study Execution, & Study Interpretation
- Drives all Clinical Science department activities relating to the preparation / approval of Synopses, Protocols and the conduct of clinical studies. Serves as an advisor to the clinical scientists involved in these activities, and be accountable to senior company management for the successful completion of underlying objectives. For the assigned compounds, accountable for the successful completion of projects undertaken - and for pro-active contingency planning / interventions necessary to ensure achievement of related goals.
- Interprets data from an overall scientific standpoint as well as within the context of the medical significance to individual patients.
Trial Medical Monitoring
- Oversees medical monitoring activities, assessing issues related to protocol conduct and/or individual subject safety. Assesses overall safety information for studies and compounds in conjunction with Pharmacovigilance.
External Interactions
- Directs activities involved in interactions with regulatory authorities/agencies and clinical development and key opinion leaders relevant to assigned compounds. Provides leadership and serves as an advisor to the other clinical scientists engaged in these activities and, in the context of these responsibilities, will be accountable to senior leadership for the successful completion of related objectives.
Leadership, Task Force Participation, Upper Management Accountability
- Interacts directly with research division based on pertinent clinical and development expertise and with US/EU to provide knowledge/understanding of market environment in line with status as R&D scientific content matter expert for assigned compounds. Represents clinical science on high impact/priority task forces across the organization or external to the company. Leads R&D internal teams and global cross-functional teams.
- Hires, manages, mentors, motivates, empowers, develops and retains staff to support assigned activities. Conducts performance reviews and drive goal setting and development planning.
Education & Competencies
Education/Experience
- MD or internationally recognized equivalent plus 3 years of clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned).
- Previous experience successfully leading a clinical development team/matrix team with responsibility for studies.
- JNDA/NDA/MAA/Submission experience preferred
- Experience with and demonstrated ability to lead and manage highly trained medical, scientific and technical professionals preferred
Skills
- Superior communication, strategic, interpersonal and negotiating skills
- Ability to proactively predict issues and solve problems
- Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix teams
- Diplomacy and positive influencing abilities across multinational business cultures
Knowledge
- Therapeutic area knowledge relevant to mechanisms of action of compounds in remit
- Regional/global Regulatory requirements
- GCP/ICH
- Emerging research in designated therapeutic area
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.