- Leads a team of approximately 50 employees dedicated to the collection, analysis and reporting of Medtronic clinical surveillance data to characterize product/procedure performance and provide a feedback loop to product/procedure development.
- Partners closely with all Medtronic Business Units on multiple, high-risk therapies to design surveillance programs to assess performance and provide meaningful data for product improvements. Promotes collaborative, transparent business relationships between surveillance team and Business Units.
- Partners closely with Data Science PDN and Clinical Research Community to develop innovative approaches to generate post approval cost effective real-world evidence.
- Will be a member of the global Clinical Research Council to represent Data Science and drive strategic and operational execution in delivering cost-effective evidence in the post-market surveillance space.
- Provides surveillance expertise in regulatory and quality negotiations with regulatory authorities.
- Supports development of reports used by Medical Safety, Medical Affairs and other governing bodies to support review and interpretation of safety and evidence data within the surveillance space.
- Drives global expansion and ongoing assessment of existing participating sites to ensure quality data and cost-effective execution at these centers. Assesses and grows Medtronic Surveillance Site Network to meet the increasing demand for global, representative participation to match Medtronic product and procedure use.
- Leads governance of the Medtronic Product Surveillance Registry (PSR) program to make sure all products and procedures included maintain the core essence of program tenets. Building strategic and innovative ways to improve PSR program to maintain scientific rigor, statistical modeling, high quality and cost effectiveness to produce meaningful, significant data.
- Directs development and implementation of all established surveillance programs for product performance.
- Collaborates closely with other Medtronic Surveillance leadership on understanding innovative approaches that increase value to internal and external stakeholders. Supports development of signal detection methodology for Medtronic products and procedures.
- Focus on continuous improvement to identify opportunities for greater operational efficiency and scalable solutions for improved produce and procedure surveillance.
- Responsible for organization performance of teams to meet internal customer needs including high quality work, activities model (time tracking, ECU, R&R), and SOW with budget and milestones.
- Engage in the organization’s strategic planning process, prepare and manage annual operating budget, headcount management, finance/customer service modeling and general department logistics and administration for defined areas of the post market studies organization. Provide leadership, support, and mentoring staff. Engage in staff recruitment as appropriate
BASIC QUALIFICATIONS EDUCATION REQUIRED
- Bachelor’s Degree in engineering, biological sciences or other relevant medical/scientific or business field.
YEARS OF EXPERIENCE
- 10+ years’ experience directly supporting clinical research or research experience in a medical/scientific area.
- 5+ years’ direct people management experience.
- Strategic planning, financial modeling and budgeting experience
- Advanced degree in a technical field. Technical degree defined as engineering, biological sciences or related medical/scientific area.
- Regulatory and quality experience
- Expertise with GCPs, regulatory, quality and compliance guidelines for clinical trials.
- Knowledge of clinical and outcomes research study design, statistical methods, and clinical research study management
- Business acumen/strategic thinking skills
- Ability to drive successful/positive change management
- Able to pull a team together under a common/shared vision and goal.
- Empowers team, able to delegate successfully
- Excellent people management skills – lead, motivate, select, retain, develop, and coach.
- Strong analytical skills, including ability to interpret data and draw conclusions relevant to work at hand
- Strong track record of execution and delivery results with high attention to detail and accuracy
- Advanced oral and written communication skills, including ability to present work in a clear and confident and enthusiastic manner.
- Ability to manage multiple tasks and demonstrate flexibility
- Good problem-solving skills and ability to think out of the box
- Excellent listening skills
- Courage to speak up