Medical Director/Associate Director, MPD Clinical Science

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Job Description

OBJECTIVES:

• The Medical Director of MPD Clinical Science in Osaka (MDMP in Osaka) is accountable for Sponsor clinical and medical oversight for assigned marketed products globally including Japan  as well as Japan-specific products within MPD remit. Participates in new business evaluation.  Usually responsible for multiple products.
• The MDMP in Osaka is an integral member of the Marketed Products Development (MPD) that is responsible for providing dedicated R&D support for the products under its purview. The MDMP interacts and partners with marketed products R&D function leads (regulatory affairs, pharmacovigilance, global development operations and project management) to set R&D strategy and prioritise and deliver R&D functional support for assigned MP portfolio, that is aligned with the broader business objectives for the portfolio. This individual is responsible for medical and clinical scientific leadership and execution for the assigned products on the specific global program teams (GPT), the product support teams (PST) or the established product inspired collaboration (EPIC) oversight team .
• The MDMP provides Sponsor clinical and medical Oversight and support for assigned  products as part of the dedicated, integrated R&D support to ensure the ability of Takeda to meet its corporate obligations as MAH for assigned products. The MDMP provides medical and clinical leadership to anticipate potential compliance risks, and has appropriate contingency plans in place to allow the rapid response to regulatory agency, scientific, or commercial hurdles.
• The MDMP will be required to be the medical and clinical scientific expert for the assigned products and to develop and maintain an up-to-date expert knowledge of the scientific, medical and regulatory aspects of the products in order to provide medical, clinical and scientific support, guidance, mentoring and leadership across these areas.

ACCOUNTABILITIES:

The Medical Director of MPD Clinical Science in Osaka will be responsible for, and participate in the following activities:

Marketed Product R&D support & Leadership

• 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.

Japan specific product R&D support & Leadership

• Japan Development team (JDT) team leader and an expert of Clinical Science in JDT for the assigned marketed product or the assigned Japan specific newly developing product.  Provide medical and clinical scientific lead as well as exerting leadership as a JDT team leader in conducting and promoting clinical activities of the team partnering with Project Management.
• Establish integrated partnership(s) with R&D functional leads on assigned JDT such as regulatory affairs, pharmacovigilance, clinical operations, stats and with strategic partner vendor(s).
• In collaboration with Japan Business Unit (JPBU), exerts leadership from the aspect of Clinical Science in conducting and promoting clinical activities including life-cycle management to maximize the value of the assigned product(s).
• Form integrated partnerships and collaborate with all relevant cross-divisional stakeholders involved in the support of assigned products, including but not limited to, Quality, Global Manufacturing and Supply, Japan Medical Office. 
• As a manager in MPD clinical science, provides advice to his/her direct report(s) on the task management, career development, education, etc.

External Interactions

• Build and develop medical and clinical expert relationships to ensure delivery and maintenance of  state-of-the-art medical therapeutic and clinical scientific expertise into medical and clinical R&D support for assigned marketed products
• Participates in meetings with regulatory agencies as required
• Represent Takeda on external bodies as needed.

Due Diligence, Business Development & Alliance Projects

• Participate and conduct clinical due diligence evaluations and development of clinical development plans for potential alliances and or in-licensing opportunities.
• Assess both scientific and development feasibility, evaluating strategic fit with overall portfolio, evaluating complete or ongoing clinical trials, assessing regulatory interactions and future development plans, interacting with upper management of potential partner/acquisition companies during due diligence visits and alliance negotiations, and actively participating on internal assessment teams in conjunction with commercial colleagues.

EDUCATION, EXPERIENCE AND SKILLS：

• MD or internationally recognized equivalent plus 3~6 years of clinical research experience within the pharmaceutical industry, CRO, health-related consulting company, or biomedical/clinical experience within academia or clinical practice (or a combination of afore mentioned).
• Track record and demonstrated ability to lead and manage both science and business aspects of drug development.
• Experience with and demonstrated ability to lead and manage highly trained medical, scientific and technical professionals
• NDA/MAA/Submission experience 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

• Regional/global Regulatory requirements
• GCP/ICH

LANGUAGE AND OVERSEAS WORK EXPERIENCE：

• English skill is required to use without problem in business and discussion with global employees
• Fluency in Japanese required
• Working experience in a global team or environment is preferable.

BEHAVIOURAL COMPETENCIES : 

• Strong written and verbal Communication Skills: ability to communicate complex information in a clear and engaging manner.  ability to inspire commitment through a wide range of communication channels (meetings, writings, presentations)
• Establish productive relationships and partners with others across the organization: ability to reinforce open dialogue and exchange of perspectives through a variety of methods (meetings, conference calls, cross-functional teams, etc.). ability to cultivate a broad network of relationships throughout Takeda, with affiliates and alliance partners.
• Leadership skills: ability to understand differences in practices across organizations or countries, and balances local demands and perspectives with global strategies   ability to make key decisions with an effective combination of thoughtful analysis, buy-in and speed

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.

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