Kristen Drake
VP Clinical Affairs @ StimCardio Medical
About
Enthusiastic and experienced professional with a demonstrated history of achieving excellence in the biotechnology industry. Skilled in Medical & Combination Devices, Clinical Operations, clinical informatics systems implementation, Neurosurgery, Neurology, Psychiatry, Cardiology, Cardiac Electrophysiology, Ophthalmology, FDA, ICH GCP, internal & external auditing, clinical & regulatory affairs, creative & analytical strategy, AI & ML applications in life sciences, and cross-functional/international relations. Master's in Health Education & Health Sciences with a focus in Physiology; B.S. in Clinical Psychology.
United States
Dallas-Fort Worth Metroplex
Biotechnology
Clinical Operations, Communications, Project Management, Research, Regulatory Affairs, Medicine, ISO 13485, Medical Devices, FDA, Clinical Research, Clinical Trials, Cross-functional Team Leadership, GCP, Validation, Process Improvement, Lifesciences, Team Building, Product Launch, Product Development, Quality System
Experience

Clinical Operations & Regulatory Affairs Consultant
Dallas, TX USA
• Provide strategic guidance on global clinical operations and regulatory compliance across multiple regions, including FDA and ICH. • Develop and execute clinical protocols and databases, enhancing operational efficiency and data integrity. • Conduct comprehensive audits for GCP and BIMO, ensuring adherence to regulatory standards and improving audit outcomes. • Areas of Clinical work: cardiology, cardiothoracic surgery, neurosurgery, psychiatry, ophthalmology, neurology

Senior Clinical Director
Functional Neuromodulation (in partnership with Boston Scientific)
North America

Senior Clinical Director
Functional Neuromodulation (in partnership with Boston Scientific)
North America
Functional Neuromodulation Ltd. is dedicated to advancing the application of deep brain stimulation (DBS) therapies to help improve the lives of people with Alzheimer’s and other memory and cognitive disorders. The company is investigating the use of DBS of the fornix (DBS-f) to drive neural activity and modulate the brain’s memory circuit. The company has raised a total of $13.4 in funding commitments from Genesys Capital, Foundation Medical Partners and Medtronic, Inc. Building on early clinical data, the company has initiated the ADvance Study, a multi-center feasibility study of DBS-f in patients with mild Alzheimer’s. The ADvance Study is also supported through a translational grant of up to $2.75M from the National Institute on Aging, part of the National Institutes of Health.

Manager, Global Operations - Clinical eSuite
Syneos Health (originally INC)
Global
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. At Syneos Health, we’ve built an advanced technology infrastructure and are using sophisticated data analytics and AI/ML capabilities to improve outcomes at every stage of the asset lifecycle, from clinical development to commercialization. Our approach to tech-enabled problem-solving is to be agile and intentionally pragmatic. We focus on your real-world challenges with intelligent applications and customized technology solutions for protocol design, strategic feasibility, patient enrollment, diversity in clinical trials, data transparency and interoperability, medical and scientific exchange, HCP engagement and market intelligence.

Senior Clinical Manager
Functional Neuromodulation (in partnership with Medtronic)
www.functionalneuromodulation.com
Functional Neuromodulation Ltd. is dedicated to advancing the application of deep brain stimulation (DBS) therapies to help improve the lives of people with Alzheimer’s and other memory and cognitive disorders. The company is investigating the use of DBS of the fornix (DBS-f) to drive neural activity and modulate the brain’s memory circuit. The company has raised a total of $13.4 in funding commitments from Genesys Capital, Foundation Medical Partners and Medtronic, Inc. Building on early clinical data, the company has initiated the ADvance Study, a multi-center feasibility study of DBS-f in patients with mild Alzheimer’s. The ADvance Study is also supported through a translational grant of up to $2.75M from the National Institute on Aging, part of the National Institutes of Health.

Research Quality Improvement Specialist
Dallas–Fort Worth metroplex, Texas, United States
Baylor Scott & White Research Institute (BSWRI) is the dedicated research and development arm of the largest not-for-profit healthcare system in Texas. BSWRI provides the critical infrastructure and operational resources needed to both safely and effectively conduct research across a broad range of specialty areas.

Director, Corporate, Global Regulatory Affairs
Flextronics (Avail Medical)
Irving, Texas, United States
End-to-end capabilities that transform healthcare, from concept to care - Based in the Flextronics Avail Medical Products division with corporate medical regulatory responsibilities for all of Flextronics.

Director, Clinical and Regulatory Affairs
Organ Transport Systems
Plano, TX

Clinical Project Manager/Sr. CRA
St. Jude Medical - Advanced Neuromodulation Systems
Plano, TX
Neurostimulation therapies from Abbott allow people living with chronic pain and movement disorders to move easier and feel better. Neurostimulation is a medication-free* technology that can help chronic pain patients get back to living their lives. It also can combat the symptoms of movement disorders for those living with Parkinson's disease or essential tremor so daily tasks aren't as difficult.
Kristen Drake's Contact Information
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