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We anticipate the application window for this opening will close on - 6 Jun 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 Sr. Clinical Research Director, Core Surgical Innovations (CSI) reports to the VP, Clinical Research & Medical Science, Surgical. This position is responsible for directing all global clinical research activities and programs to generate clinical evidence in support of the business. The Clinical Research Leader is responsible for developing the clinical strategy in alignment with the business, R&D and commercial strategies for the CSI Business Unit. The leader is also responsible for designing and driving the execution of pre-market and post-market clinical trials globally, including driving outcomes and results, and collaborating for the dissemination of the resulting evidence to internal and external stakeholders. The goal of these programs is to develop the medical evidence necessary to demonstrate safety, efficacy, economic and quality of life outcomes for the performance of our products and therapies. Programs will support global regulatory approval, reimbursement coverage through comparative effectiveness evidence, therapy adoption and new indications. The CSI Clinical Leader helps set the strategy and manages/approves funding for external physician-initiated research programs (ERP) on a global basis in partnership with the ERP Lead for Surgical. In addition, the leader will collaborate closely with the Health Economic Evidence team to provide additional value to the business.

Ideal candidate would work from our Boston, or North Haven site. We will consider candidates from Europe, with a preference for London, or remote within the US.

+ Lead global strategic clinical plan process, investment prioritization efforts, and area reviews. Create the global strategic clinical plan and lead the development of regional clinical strategies.

+ Lead the process to define the key stakeholder needs (including but not limited to customer, regulatory agency and payer requirements) for medical evidence for the safety, efficacy, and economic outcomes necessary to establish our therapies as the standard of care.

+ Provide strategic leadership to evidence generation activities including design of Clinical trials retrospective database analysis, meta-analysis, translation of clinical data to marketing messages and other health service research endeavors.

+ Have a working knowledge of patient reported outcomes instruments, and development of value messages to satisfy stakeholder needs.

+ Set the strategy and manage/approve funding for external physician-initiated research programs (ERP).

+ Develop and maintain an extensive physician network globally to understand customer needs and convey the evidence supporting the preferential use of our products and therapies.

+ Play a leading role in the development of evidence to support clinically and economically differentiated products for specific (emerging and developed) markets. Ensure that clinical trial design is aimed at fulfilling the common and unique needs of different geographies.

+ Successfully create, initiate, and conduct studies consistent with the clinical strategy and business unit objectives. In collaboration with the clinical research organization this includes Clinical Investigation Protocol (CIP) creation, budget drafting and management, trial execution, publication and evidence dissemination.

+ Direct trial concept assessment and creation with functional leaders’ support

+ Ensure effectiveness of CSI global clinical activities through strong collaboration and communication with Geography, Clinical Function, Marketing, Research, Technology, Product Development and Operating Unit leadership regarding clinical research and link to the overall business strategy.

+ Assume primary accountability for clinical trial strategy and execution.

+ Interact directly with senior leaders and executives to bring awareness and achieve resolution of significant issues concerning products and therapies detected during clinical trials.

+ Collaborate with Regulatory, Reimbursement, Healthcare Economics, and Marketing to develop and execute plans to utilize the results of clinical trials to advance business objectives.

+ Work cross-functionally and with external advisors, consultants and investigators to direct publication plans to ensure dissemination of clinical and economic evidence through manuscripts, society meetings presentations, payer presentations, etc.

+ Interface with representatives from key functional groups including field clinical and technical staff, Product Development, Marketing, Sales, Regulatory Affairs and Quality and local governing bodies.

+ Ensure the publishing of results and collaboration with physicians to make known the outcomes of studies and corresponding medical advancements.

+ Represent the CSI BU on matters related to clinical evaluation of products and therapies internally and externally.

+ Represent CSI business clinical research internationally and build deeper local market knowledge and connections regarding products and strategies. Support global product launches, training, and customer support plans. Collaborate with geography clinical and business leads to create local clinical strategies.

+ Collaborate with Business Development in the identification, early evaluation, and due diligence of opportunities for investment or acquisition.

+ Manage expenses within budget, maximizing effectiveness and efficiency.

+ Work within and actively promote Medtronic’s core mission, corporate strategies, policies, procedures and Code of Conduct.

Responsibilities may include the following and other duties may be assigned.

+ Provides leadership for the conduct of clinical studies as it applies to product approval, launch, adoption and maintenance.

+ 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, oversees clinical research projects over all of the products and therapies within the CSI BU.

Must Have: Minimum Requirements

+ Advanced degree (Master of Science, Ph.D., PharmD, or MBA)

+ 15+ years of experience in clinical research in the medical device industry with IDE and PMA submission experience

+ 10+ years of progressive managerial experience in clinical research

Nice to Have

+ Demonstrated ability to build deep product and therapy knowledge

+ Demonstrated ability to work with FDA and other global regulatory agencies and bodies

+ Work experience directly in a strategic clinical or marketing role

+ Demonstrated ability of research skills for study design and analysis

+ Demonstrated knowledge of Data Management and Clinical trial processes

+ Understanding of dynamic clinical research environment, including global regulations and policies

+ Strong interpersonal skills and ability to collaborate with and influence physicians, nurses, and regulators.

+ Demonstrated ability to work with organizational decision makers – Executives, R&D, Marketing, Regulatory, etc.

+ Ability to maintain proactive relationship with R&D, Marketing and Regulatory within CRM and Medtronic

+ Demonstrated use of business and financial measures

+ Excellent communication and presentation skills -- written and verbal

+ Demonstrating ability to negotiate and utilize effective influencing and sales 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.

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):$266,400.00 - $399,600.00

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.

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 (https://www3.benefitsolver.com/benefits/BenefitSolverView?page\_name=signon&co\_num=30601&co\_affid=medtronic)

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 (http://www.medtronic.com) .

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 (https://www.medtronic.com/content/dam/medtronic-wide/public/united-states/employee-support-services/careers/la-county-legal-notice.pdf) 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.

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) .

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