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 Clinical Research Director for Pelvic Health reports to the VP, Clinical Research and Medical Science NMPH. 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 supporting the clinical strategy in alignment with the business, R&D, regulatory and commercial strategies for the pain therapies business. 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.Responsibilities may include the following and other duties may be assigned:
- Provides leadership for the conduct of clinical studies and in the development of clinical evidence for pre-market and post-market trials/studies as it applies to product lifecycle.
- 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.
- Collaborates with cross-functional partners to develop a therapy-specific clinical evidence strategy incorporating data generated from clinical studies.
- Provide strategic leadership to evidence generation activities including design of Clinical trials retrospective database analysis, meta-analysis, translation of clinical data to marketing messages.
- Creates a systematic approach to evidence dissemination from clinical study portfolio.
- Experience supporting clinical modules for PMA submissions and global submissions for Class III medical devices, inclusive of regional global regulatory bodies.
- Assume primary accountability for clinical trial execution.
- 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.
- Represents Medtronic from a clinical research respective within the country/region and also collects feedback from local customers and authorities. 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, etc.
Must have Requirements:
- Advanced degree (Master of Science, Ph.D., PharmD)
- Minimum of 8 years of clinical related experience with 7+ years of managerial experience
Nice to have/Preferred Requirements:
- Work experience directly in a strategic clinical or marketing role
- Demonstrated ability of research skills and data analytics
- Analyzes complex issues and significantly improves, changes, or adapts existing methods
- Experience developing and maintaining project plans for multiple projects and provide weekly and/or monthly status reporting to upper management.
- Understanding of dynamic clinical research environment including global regulations and policies
- Strong interpersonal skills and ability to collaborate with internal and external stakeholders
- Demonstrated ability maintain proactive relationship with Executives, R&D, Marketing, Regulatory etc across 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.
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 90,000+ 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.
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