Tokyo, JPN
18 hours ago
Japan Clinical Research Director
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. **A Day in the Life** The MCRS Clinical Director, Japan Region is responsible for overseeing all aspects of the MCRS functions for the JAPAN region, including direct management of MCRS resources in Japan and indirect management of resources in rest of JAPAN region. This position accomplishes results through delegation of responsibility to others, including Monitoring Managers/Safety Managers and sometimes individual contributors (such as Monitors, Safety Specialists or equivalent), who exercise significant latitude and independence in their assignments. This role is strategic in nature and results are accomplished through planning, organizing, business management, organizational development and personnel oversight. This position is responsible for results in terms of costs, quality, compliance, methods and people in meeting study-specific and cross-departmental goals. This includes meeting required monitoring milestones and group objectives as well as internal and external customer satisfaction. Reports to the Vice President, MCRS ISS Global. + Responsible and Accountable for ensuring appropriate MCRS structure and strategy is in place to meet business needs in JAPAN region. This would include defining the strategic needs globally for the region (looking forward 2-3 years) and building infrastructure to support the strategy. + Accountable for Strategic planning and organizational design, resourcing, and talent management for the MCRS organization to enable the Business unit or therapy that they support to execute its patient safety and market access mandates. + Drives cost innovation, simplification, and performance improvement in all MCRS processes locally through lean-six sigma strategies. + Responsible and Accountable for the overall execution of MCRS activities for an assigned business unit, therapy, group(s) or region. + Responsible for results in terms of costs, quality, compliance, methods and employees, within assigned regions ensuring that ongoing operations, processes and programs are completed on schedule and within budget + Interprets, creates and executes policies and procedures and recommends modifications to operating policies (region specific customizations as required). + Responsible for the oversight and review of MCRS metrics/key performance indicators for the assigned business unit, therapy, group(s) or region. Ensures appropriate actions are taken based on key performance indicators. + Sponsor and actively monitor a performance management culture where all employees have clear performance expectations. Provide targeted coaching and feedback. Clearly identify and communicate the differentiation of talent and assure development actions and rewards align accordingly. Conduct timely and candid performance evaluations. Support meaningful development plans and related activities. + Responsible for resource management within the assigned business unity, therapy, group(s) or region working closely with MCRS Managers/Supervisors to ensure that MCRS resources are sufficient to meet local requirements + Lead briefings and meetings with internal and external contacts, groups within the assigned regions to meet business needs + Active collaboration with other MCRS functional leaders and Managers to ensure study milestones are met across regions and MCRS customer experience is at the required level. + Involved in escalation and resolution of issues within business unit and/or therapy + Oversee the review or creation of study specific materials (Clinical Investigational Plan, Case Report Forms, Monitoring Plan, etc.) Responsibilities may include the following and other duties may be assigned. + Provides leadership for the conduct of clinical studies and for the regulatory affairs function as it applies to product approval. + Studies must be scientifically valid, meet all relevant regulatory requirements and be conducted within ethical guidelines. + The end result of the clinical studies must be a fair assessment of the safety and efficacy of the tested product (s) and attainment of product approvals in a timely matter. + Develops and implements regulatory strategies to obtain timely product approvals form worldwide regulatory bodies. + Ensures regulatory submissions are accurately prepared and comply with regulatory approvals. + People working within region/country may also have the responsibilities that include: + Represents Medtronic from a clinical research respective within the country / region and also collects feedback from local customers and authorities. + Builds and maintains a strong network and close relationship with the various internal and external parties. + Leads execution for both local and global studies, manages clinical research projects over all of the Medtronic therapies across multiple businesses. **PEOPLE MANAGEMENT FUNCTIONAL CAREER STREAM:** Management and supervisory professionals with one or more employees who are focused on tactical, operational and some strategic activities within a specified area. Levels within the management career stream typically have six or more direct reports. The majority of time is spent overseeing their area of responsibility, managing performance, developing talent, engagement and inclusion, communicating business and operational developments, planning, prioritizing and / or directing the responsibilities of direct reports. Goal achievement is typically accomplished through performance of direct and / or indirect reports. A key responsibility of roles in this career stream is managing people. which includes: accountability for mentoring, developing and coaching staff on meeting/exceeding performance expectations and defined objectives, providing leadership to staff ensuring the prioritization of strategic and department level initiatives to include defining performance goals and targets, conducting performance reviews, and staff 1:1s to guide performance management and employee development efforts and manage toward departmental goals. **DIFFERENTIATING FACTORS** **Autonomy:** **-** Manages department (s) or small unit that includes multiple teams led by managers and / or supervisors. - Provides motivational leadership for the area managed. - Provides thought and technical leadership . - Performs work without appreciable direction. **Organizational Impact:** **-** Leads the development of the strategy for own department or business area, ensuring links to the company’s aims and objectives. - Management authority to make large business decisions and some strategic decisions. - Decisions impact the financial performance, employees, or public image of the operational unit and/or company. - Typically has budget or P&L accountability for a department, broad functional area or geography. **Innovation and Complexity:** **-** Drives innovation across the business area, encouraging best practice and knowledge sharing. - Significantly improves, changes or adapts own department or business area’s processes, systems, products or services. - Problems and issues faced are complex, difficult and undefined, and require detailed information gathering, analysis and investigation to understand the problem. **Communication and Influence:** **-** Develops long term strategic relationships and alliances with key internal and external stakeholders. - Communicates and conducts briefings with senior or executive leadership regarding ongoing operations and strategic initiatives . - Influences across functions and businesses to negotiate and gain cooperation on operational issues and internal divergent objectives. **Leadership and Talent Management:** **-** Directs and leads a department, broad functional area or geography, including one or more teams led by managers and / or supervisors . - Determines supervisory relationships, and creates workforce and staffing plans to accomplish business results . - Authorizes hiring, firing, promotion and reward within own area. **Required Knowledge and Experience:** **-** Requires broad management and leadership knowledge to lead multiple job areas, and detailed functional and operational expertise. - Typically has mastery level knowledge and skills within a specific technical or professional discipline with broad understanding of other areas within the job function. - Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum of 10 years of relevant experience with 7+ years of managerial experience, or advanced degree with a minimum of 8 years of relevant experience with 7+ years of managerial experience. - Requires fluent Japanese & English language skills **Physical Job Requirements** The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.  **Benefits & Compensation** **Medtronic offers a competitive Salary and flexible Benefits Package** A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). This position is eligible for an annual long-term incentive plan. **About Medtronic** We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here (http://www.medtronic.com) **Welcome to our new Careers Site!** **If you applied before July 22nd, please check your email for a notification from us providing you with instructions and a link to set up your new account and retain access to your current activity. If you do not see an email from us, please feel free to proceed with creating a new account.** We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. **We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. **We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. **This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will… + **Build** a better future, amplifying your impact on the causes that matter to you and the world + **Grow** a career reflective of your passion and abilities + **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning These commitments set our team apart from the rest: **Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need. **Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. **Better outcomes for our world** . Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls. **Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here (https://www.e-verify.gov/employees) . For updates on job applications, please go to the candidate login page and sign in to check your application status. If you need assistance completing your application please email AskHR@medtronic.com To request removal of your personal information from our systems please email RS.HRCompliance@medtronic.com
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