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Clinical
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200004IT Requisition #
Location: Remote-based.  Boulder, CO preferred
 

Careers That Change Lives

Help lead the effort to create global strategies for worldwide medical device approvals to introduce new products to market.

 

In this exciting role as a Sr Manager, Clinical Affairs, you will be responsible for managing activities of clinical research programs for one or more product families in the Gastrointestinal & Hepatology (GIH) division of the Respiratory, Gastrointestinal & Informatics (RGI) global business unit. This role manages a team of professional and support staff, and supports Medical Affairs initiatives to drive mission-oriented programs that enable the business strategy.  The Sr Manager will be responsible for development and/or review and approval of clinical study protocols, site selection, monitoring of studies, assessment of clinical results, and training support staff, field personnel and users, and review and approval of study reports.

 

Come for a job, stay for a career.

 

The Minimally Invasive Therapies Group (MITG) strives to enable earlier diagnosis, better treatment, faster complication-free recovery, and enhanced patient outcomes through less invasive surgical solutions.

 

The Gastrointestinal & Hepatology (GIH) division of the RGI business unit develops diagnostic and therapeutic solutions that enable early detection and treatment of gastrointestinal diseases and cancers.

 
A Day in the Life
 

Responsibilities of the Sr. Manager and their team may include pre and/or post-market clinical research, clinical evidence development, clinical strategy, clinical operations, adhering to the Clinical Quality Management System (cQMS), representing and providing clinical input to product development core teams on the design of products, input to risk documents, input to and review of Clinical Evaluation Reports and other regulatory or marketing materials, and review of patient safety issues as requested. 

 

Works closely with partners inside Medical and Clinical Affairs as well as across the broader global, regional and functional organizations to achieve objectives (for example: Regulatory, Research & Development, Quality, Marketing, Scientific Communications, Medtronic Core Clinical Solutions).

 

Position reports to the Director, Clinical Affairs for the GIH division of the RGI business unit.

 

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

  • Provides leadership for the design and conduct of clinical studies
  • Manages a team of direct reports (professionals and support staff), ensuring talent development, establishing goals and managing performance, conducting performance reviews.
  • Development of clinical research strategies in alignment with the business priorities to ensure robust evidence generation for global market access and market development
  • 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 performance of the tested product (s) and attainment of product approvals (or published articles) in a timely matter.
  • Builds and maintains a strong network and close relationship with the various internal and external parties.
  • Leads execution for both local and global studies for one or more product families in the Gastrointestinal & Hepatology (GIH) division of the RGI global business unit.
  • The Sr. Manager and/or their staff may be required to represent the Medical/Clinical Affairs function on product development (or other) core teams
  • Presents to senior leadership to gain approval for projects and to present status updates

Must Have (Minimum Requirements):

To be considered for this role, the minimum requirements must be evident on your resume.

  • Bachelor’s degree required and a minimum of 7 years of experience in clinical research/medical affairs with 5+ years of managerial experience, or advanced degree with a minimum of 5 years of experience in clinical research/medical affairs with 5+ years of managerial experience. 

Nice to Have (Preferred Qualifications):

  • Advanced Degree MS or PhD or MD.
  • Experience at Medtronic or in medical device industry clinical trials. Familiar with Medical Device and/or combination product trials and regulations.
  • Cost-center/budget management experience.
  • Product development experience including global clinical strategy development
  • Experience managing direct reports in various locations.
 

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 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. (ADA-United States of America)

 

Travel up to 50% (domestic and international).


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