Careers That Change Lives
The increasing number and complexity of new products in Medtronics development pipeline and surging demands for clinical evidence is driving a need for a new business model that will deliver an efficient and effective generation of clinical evidence to fulfill regulatory requirements and meet product performance surveillance demands. This position is responsible for creating and implementing a real-world data and evidence strategy by using clinical practice data from real-world data sources. The objective is to provide thought and people leadership, and to support the development of new frameworks and methods to inform related efforts across the enterprise to drive change toward this evolving real-world evidence methodology. The successful candidate will have a track record of execution, especially the energy and drive to implement successful transformational business models. Strategic thinking, study design expertise, and an ability to navigate, influence and align across the matrix and with critical and influential external partners are key skill sets. Day in the Life Provides leadership in developing critical requirements for the utilization of real-world data sources to deliver high quality post-market evidence. Makes decisions from pilot learnings and operationalizes these decisions to help shape the future use of real-world data extraction and use. Recommends strategies, goals and plans for a group. Executes assignments in objective-oriented terms while independently leveraging and maintaining an entrepreneurial and agile learning environment. Initiates and manages programs or projects based on identified business and / or tactical needs. Decisions impact projects or operations, affect the deadlines, resources, and funds, and the achievement of organizational objectives. Develops new objectives, processes and standards in support as needed. Work must be scientific, meet relevant clinical and regulatory requirements and conducted within ethical guidelines. Establishes tools, methods or new frameworks. Problems and issues faced are complex, difficult and undefined, and require detailed information gathering, analysis and investigation to understand the problem. Applies expertise in study design (optimizing efficiency, control for bias, and endpoint definition and ascertainment) to effectively develop innovative solutions for clinical and regulatory requirements. Leads a team of employees focused on the execution of a methodology-driven strategy for the vision. Requires broad management knowledge to lead project teams. Manages employees who are focused on tactical, operational and some strategic activities within a specified area. Oversee team areas of responsibility, manage performance, develop talent, planning, prioritizing and / or directing the responsibilities of direct reports. Goal achievement is accomplished through performance of direct and / or indirect reports. Defines key milestones and helps develop realistic project plans. Manages hiring, firing, promotion and reward within own area. Manages and is responsible for own budget. Communicates with internal and external customers for advocacy in creating and delivering a real-world evidence strategy External representative and voice for new methodology in delivering post-market evidence. Develops and implements strategies to engage with regulatory bodies. Partners closely with solution consumers to make sure that efforts address their needs. Influences across functions and businesses while balancing divergent objectives to gain cooperation of other parties. Must Have Bachelor degree in business, scientific, healthcare or related field. 10 years of relevant clinical research experience 5 years of managerial experience Experience in medical device or healthcare space Nice to Have Masters Degree in clinical or scientific field of study (e.g., biological science, social science, engineering, or other related medical/scientific field), MBA, or doctoral degree Experience executing disruptive business models Strategic thinking, including proven success in taking concepts to value recognition Strong communication (oral and written), presentation, and interpersonal skills Analytical skills with the ability to define problems, collect data, establish facts, and draw valid conclusions The ability to negotiate and manage competing priorities across multiple clinical quality programs and areas Influence management skills; ability to work cooperatively at all levels in matrix environment to build and maintain the positive relationships required to accomplish organizational goals Effective decision-making skills-ability to negotiate and balance decisions and priorities across needs of several functional departments. Makes timely decisions in the face of risk and uncertainty. Demonstrated ability to identify and adapt to shifting priorities and competing demands, and maintain composure in difficult circumstances. Physical Job Requirements
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, communicate with peers and co-workers, and spend extended periods of time doing computer-based work.
Associated topics: dietician, drug discovery, histologist, immuno oncology, medicine, patient, pharmacy, physiologist, protein, toxicologist