Kristen Drake

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.

Country

United States

City

Dallas-Fort Worth Metroplex

Industry

Biotechnology

Skill

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

StimCardio Medical

VP Clinical Affairs

StimCardio Medical

LinkedIn
2026-2 - Present · 8 mos
kd Consulting

Clinical Operations & Regulatory Affairs Consultant

kd Consulting

LinkedIn
2024-10 - 2026-2 · 1 yr 5 mos

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

Newronika S.p.A.

VP Clinical & Regulatory Affairs

Newronika S.p.A.

LinkedIn
2023-4 - 2024-9 · 1 yr 6 mos

Cologno Monzese, Lombardy, Italy

Restoring brain and body functions with neural devices. Newronika builds innovative neural devices based on its vast knowledge of biosignal decoding.

Functional Neuromodulation (in partnership with Boston Scientific)

Senior Clinical Director

Functional Neuromodulation (in partnership with Boston Scientific)

2023-4 - 2023-12 · 9 mos

North America

Functional Neuromodulation (in partnership with Boston Scientific)

Senior Clinical Director

Functional Neuromodulation (in partnership with Boston Scientific)

2019-5 - 2023-4 · 4 yrs

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.

Syneos Health (originally INC)

Manager, Global Operations - Clinical eSuite

Syneos Health (originally INC)

2016-10 - 2019-4 · 2 yrs 7 mos

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.

Functional Neuromodulation (in partnership with Medtronic)

Senior Clinical Manager

Functional Neuromodulation (in partnership with Medtronic)

2011-1 - 2016-10 · 5 yrs 10 mos

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.

Baylor University School of Law

Research Quality Improvement Specialist

Baylor University School of Law

LinkedIn
2011-1 - 2012-3 · 1 yr 3 mos

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.

Flextronics (Avail Medical)

Director, Corporate, Global Regulatory Affairs

Flextronics (Avail Medical)

2008-8 - 2011-1 · 2 yrs 6 mos

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.

Organ Transport Systems

Director, Clinical and Regulatory Affairs

Organ Transport Systems

2006-6 - 2008-7 · 2 yrs 2 mos

Plano, TX

St. Jude Medical - Advanced Neuromodulation Systems

Clinical Project Manager/Sr. CRA

St. Jude Medical - Advanced Neuromodulation Systems

2004-4 - 2006-5 · 2 yrs 2 mos

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.

Education

Michigan State University

Michigan State University

LinkedIn

Clinical Psychology

Central Michigan University

Central Michigan University

LinkedIn

Health Education and Health Sciences - Physiology

Michigan State University

Michigan State University

LinkedIn

Clinical Psychology

1986-9 - 1990-6 · 3 yrs 10 mos

Kristen Drake's Contact Information

Email

******@***.com

Phone

(**) *** ****

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