Address
Form of workThe Sr. Clinical Research Director, Cardiac Ablations Solutions (CAS) reports directly to the Chief Medical Officer, CAS. This position is responsible for directing all global Clinical Research activities and programs to generate clinical and economic evidence in support of the business. The Clinical Research Leader is responsible for developing the clinical strategy in alignment with the business and R&D strategies for the Cardiac Ablation Solutions Operating 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 CAS Clinical Leader helps set the strategy and manages/approves funding for external physician-initiated research programs (ERP) on a global basis. In addition, the leader will collaborate closely with the Economic Evidence team to provide additional value to the business.
A Day in the Life
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 CAS 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.
Take primary accountability for clinical trial 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 CAS OU on matters related to clinical evaluation of CAS Business products and therapies internally and externally.
Represent CAS 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 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.
Advanced degree (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
Deep EP 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
About Medtronic
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.
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. 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. (ADA-United States of America)
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. Learn more about our benefits here.
This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) here.
This position is eligible for an annual long-term incentive plan. Learn more about Medtronic Long-Term Incentive Plan (LTIP) here.
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).
- Posting Date: Oct 18, 2023
- Travel: Yes, < 25 % of the Time
- Salary Min: 241200
- Salary Max: 361800
