Clinical Research Director

Act boldly. Compete to win. Move with speed and decisiveness. Foster belonging. Deliver results...the right way. That's the Medtronic Mindset - our cultural norms. Our brand is rooted in action, not just words. The Medtronic Mindset defines the expectations of our culture. Every person here plays a role in bringing it to life. We recognize your extraordinary potential to ensure future generations live better, healthier lives., the Right Way - accountable for results, operating to the highest standards of ethics and quality.

Medtronic pioneered the field of neuromodulation with the first commercially available spinal cord stimulator to treat chronic pain and engineered the first deep brain stimulation (DBS) system to treat movement disorders and the first implantable drug pump to deliver medication directly to the intrathecal space of the spine. More than 40 years later, we continue to innovate, constantly challenging ourselves to disrupt the markets we created. We advance science by thinking and acting boldly, bringing together the right people with the right breadth of expertise to engineer groundbreaking therapies and technologies.

This Clinical Research Director will have the opportunity to work within the innovative, developing, and dynamic environment of Neuromodulation.  The Director will be responsible for the development of the global Clinical Research strategy for brain modulation and laser ablation (Deep Brain Stimulation, DBS, Visualase) therapies for the current indications of Parkinson's Disease, Essential Tremor, Dystonia, Obsessive Compulsive Disorder, and Epilepsy. The position will also have responsibility for the development of the clinical strategy for new indications.   The Director will work with global internal and external cross-functional leaders in the field, including Clinical Research, technology, research, development, and marketing, along with physician innovators and academic institutions. The resultant clinical strategy will create a competitive advantage for the Neurological sector. 

The position will provide leadership and guidance to direct reports on the design and implementation of pre-market and post-market global Clinical Research programs. Programs will support global regulatory approval, reimbursement coverage, and market expansion. These programs will develop the medical and economic evidence necessary to demonstrate safety, efficacy, cost-effectiveness, and quality-of-life outcomes for our products to external stakeholders, including patients, physicians, researchers, academia, hospital administrators, regulatory agencies, policymakers, and payers. The position will be on the leadership staff for the General Manager of the Brain Therapies business.

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

• Represent Clinical Research on the Brain Therapies Global Business Team to support the development and execution of therapy specific business unit strategic plans 

• 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, economic data collection/economic modeling, retrospective database analysis, meta-analysis and other health service research endeavors. 

• Have a working knowledge of patient reported outcomes instruments, and development of value messages to satisfy stakeholder needs and least burdensome ways to address funding streams for product/therapy payment.

• Apply Real World Evidence to address clinical development challenges and support new regulatory interaction using Real World Data

• Direct large-scale, hybrid clinical trials that augments traditional clinical trial data with at-home digital data collection using apps and sensors

• Direct the development and implementation of key investigator management systems that will insure the broad-based participation of key researchers and investigators in the design and conduct of global trials.

• Overseethe inclusion of data needs into the product development process(product development requirements and evidence generation).

• Direct the development and implementation of pre and post-market approval studies.  This includes cost-benefit, health outcomes and indication extension studies to ensure successful commercialization worldwide.

• Manage Clinical Research professionals focused on the conduct of clinical trials of Deep Brain Stimulation and Visualase. Provide leadership and support mentoring and recruiting new staff.

• Work 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.

• Prepare and manage annual operating budget, the strategic plan and general department logistics and administration for this area of the Clinical Research organization

• Support direct reports on grant/contract negotiation and implementation at clinical centers, monitor investigator performance to milestones and contract objectives.

• Work cross-functionally to manage the dynamic relationships inherent in Clinical Research between the department, regulatory colleagues, product development colleagues, reimbursement colleagues, marketing colleagues and others.

• Perform other responsibilities as required.

• Posting Date: Dec 15, 2023
• Travel: Yes, < 25 % of the Time
• Salary Min: 196,800
• Salary Max: 295,200