We anticipate the application window for this opening will close on - 6 May 2025 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 Endoscopy operating unit improves patient outcomes by empowering every gastroenterologist across the globe with artificial intelligence and disruptive therapeutic technologies. We develop diagnostic and therapeutic solutions that enable early detection and treatment of gastrointestinal diseases and cancers. As an Endoscopy Clinical Research Program Manager, you will have primary responsibility of managing the integrated clinical and medical science strategy for the Esophageal and Gastric portfolio. You will lead clinical evidence generation and dissemination and collaborate across the organization to drive market adoption for multiple innovations across the portfolio. This position should be able to function with minimal supervision. As an Endoscopy Clinical Research Program Manager, you will have primary responsibility of managing the integrated clinical and medical science strategy for the Esophageal and Gastric portfolio. You will lead clinical evidence generation and dissemination and collaborate across the organization to drive market adoption for multiple innovations across the portfolio. This position should be able to function with minimal supervision. The Endoscopy operating unit improves patient outcomes by empowering every gastroenterologist across the globe with artificial intelligence and disruptive therapeutic technologies. We develop diagnostic and therapeutic solutions that enable early detection and treatment of gastrointestinal diseases and cancers. Location: Lafayette, CO or Mounds View, MN - this role is not open for remote talent. Primary Job Duties: * Provide subject matter expertise to guide evidence-based targeting of the appropriate patient population, clinician, and disease state for MDT therapies. * Strategically influences potential product development and product roadmaps through providing medical / scientific input * Develops, implements, and oversees integrated CRMS strategy (in partnership with Medical Science, Medical Education, Health Economics, and Clinical Research functions) for assigned product portfolios aligned with the strategic goals of the business to enable market access and product adoption. May be involved in early clinical study development and statistical planning. * Provides scientific input for evidence generation including sponsored research, ERPs, Scientific Services, Collaborative Research and Alternative Data Source projects * Utilizes advanced subject matter expertise to provide medical / scientific input to various functions to facilitate insightful decision-making and enable achievement of business objectives * Serves as point of contact, subject matter expert, and liaison for Global and Regional level cross functional groups * Uses program management and influence skills with cross-functional partners to work towards common goals and drive execution of the CRMS strategy * Provides input into clinical evidence documents to ensure alignment with overall business strategy, including Protocols, Clinical Study Reports, EUMDR documentation (such as the Post-Market Clinical Follow-Up Plans [PMCF]), External Research Proposals (ERPs) * Tracks and leverages latest literature, regulations, clinical trends, and guidance to inform evidence strategies * Collaborates with key internal and external global/regional stakeholders to develop medical evidence reports, lead cross-functional gap analyses, determine geographic evidence prioritizations, and create future evidence strategy proposals * Creates, reviews and provides input on content, including internal and external medical education materials, key product messages and claims, promotional materials, new or existing literature and collateral, ensuring scientific validity and accuracy * Packages and disseminates medical and scientific information for both internal and external clients stakeholders * Provides evidence trainings and updates to the field team * Understands and effectively communicates current published medical / scientific knowledge. Compiles, analyzes, and summarizes data from a variety of sources as needed, and synthesizes complex data and information into succinct messages * Collaborates with R&D and Regulatory Affairs to review and approve device risk file documentation and provides medical / scientific expertise during interactions with regulatory bodies. Conducts scientific literature review for regulatory compliance purposes * Supports creation and maintenance of claim matrices to ensure accuracy and alignment with current evidence base 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. Required Knowledge and Experience: Requires practical knowledge in leading and managing the execution of processes, projects and tactics within one job area. Typically has advanced knowledge and skills within a specific technical or professional discipline with understanding of the impact of work on other areas of the organization. * Bachelor's degree with 5+ years of research or clinical research experience OR * An advanced degree with 3+ years of research or clinical research experience Nice to Have: * An advanced degree with a strong understanding of evidence-based science and research methodologies * Familiarity with endoscopy, speech pathology, gastrointestinal (GI) fields, or pharmaceutical/medical device industry experience * Ability to think strategically and identify gaps in clinical evidence, understand market challenges, and develop strategies to address these through evidence generation and marketing alignment * Strong program management and influence skills to effectively collaborate with cross-functional teams, including R&D, Regulatory Affairs, and Marketing, to drive execution of strategies and initiatives * Experience working with Key Opinion Leaders (KOLs) and clinical operations, as well as an understanding of when and how to apply real-world evidence in product development and market access strategies 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. 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. For Office Roles: 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, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. 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. Salary ranges for U.S (excl. PR) locations (USD):$129,600.00 - $194,400.00 This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others). The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program). The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums). Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico. Further details are available at the link below: Medtronic benefits and compensation plans 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 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. Learn more about our business, mission, and our commitment to diversity here. 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. If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.