Description

About ParadromicsParadromics delivers the fastest and most durable brain-computer interface (BCI) that will restore and amplify human abilities. Our BCI captures brain activity at the highest possible resolution: the individual neuron. This unparalleled access to high resolution brain data lays the foundation for complex BCI-enabled therapeutics starting with the greatest unmet medical needs in neurology, including  motor impairment, sensory deficits, and mental health. Paradromics’ scalable device architecture enables platform potential that will serve dynamic applications, leading to distinct data sets capable of building frontier models that mimic and map human thoughts, emotions, and memories. Leveraging these models, our high-data-rate BCIs will augment human experience through neuromodulation, granting enhanced abilities that were once unimaginable.Location and TravelThis position is based in Austin with up to 30% travel, including international travel as needed.  The RoleThe Vice President of Clinical Affairs will provide strategic leadership for Paradromics’ clinical research and evidence-generation activities. Reporting to the Chief Operating Office, this role is responsible for setting the overall clinical vision and strategy across U.S. and OUS initiatives.  This role is intentionally strategic and outward-facing, serving as a key clinical ambassador for Paradromics. The VP of Clinical Affairs will build and maintain relationships with key opinion leaders (KOLs), medical societies, and external stakeholders, as well as investigators and clinical partners, while identifying new clinical research, indication expansion, and evidence-generation opportunities.This position will also represent Paradromics in external partnerships, clinical due diligence, and investor-facing engagements as needed, supporting the company’s growth and long-term clinical credibility.Key Responsibilities • Lead the development and execution of Paradromics’ long-term clinical strategy across the product pipeline, from early feasibility through pivotal IDE studies and post-market evidence generation. • Serve as the primary external-facing clinical leader, establishing and maintaining strong relationships with investigators, KOLs, clinical sites, academic collaborators, medical societies, and research partners. • In collaboration with the Chief Scientific Officer, identify, evaluate, and prioritize new clinical research opportunities, including new indications, geographies, and partnership models. • Provide strategic clinical input into corporate strategy, product development priorities, and scientific and medical communications. • Collaborate closely with Regulatory, Quality, Neuroscience, Data Science & Engineering, Product Development, and Executive Management to ensure alignment between clinical strategy and overall business objectives. • Provide leadership and guidance to the overall clinical program, ensuring effective execution of clinical programs while maintaining focus on strategic objectives. • Support FDA interactions and clinical regulatory submissions, including IDE-related activities, in partnership with Regulatory Affairs leadership. • Lead and support OUS clinical initiatives, including building relationships with local clinical leaders, investigators, and health authorities, with initial emphasis on Saudi Arabia and future expansion to additional regions. • Contribute to clinical evidence-generation strategies to support future reimbursement, including planning for CPT billing code development and leveraging external consultants and partners as appropriate. • Represent Paradromics in external partnerships, clinical due diligence, advisory boards, and investor-facing discussions as needed. • Represent Paradromics at scientific conferences, investigator meetings, and other external forums. • Support publication strategy and dissemination of clinical and scientific data through peer-reviewed publications, presentations, and other forums. • Ensure clinical programs are conducted in compliance with Good Clinical Practice (GCP), applicable regulations, and internal SOPs.  Required Education and Experience• Bachelor’s degree in Engineering, Science, Medicine, or a related field.  Masters or PhD in Neuroscience or related filed preferred. • Minimum of 5 years of clinical affairs and/or clinical research experience in the medical device industry. • Experience with implantable neuromodulation, neurostimulation, neurotechnology, or brain-computer interface systems is required.• Demonstrated experience developing and leading clinical strategies across early- and late-stage clinical programs. • Strong track record of engaging and collaborating with external investigators, KOLs, and clinical research networks. • Ability to identify clinical and scientific opportunities and translate them into actionable research and evidence-generation programs. • Experience supporting FDA engagement and regulatory clinical submissions, including IDE-related activities. • Excellent communication and presentation skills, with the ability to influence both internal and external stakeholders. • Proven ability to operate effectively in a lean, cross-functional, and fast-paced environment. • Fluency in designing and interpreting translational neuroscience research experiments.• Experience in neurophysiological recording methodologies and analysis.Preferred Qualifications• Experience with reimbursement-related clinical evidence generation and CPT code development. • Experience working with active implantable medical devices containing software in a clinical or commercial setting. • Prior experience in early-stage or high-growth medical device or neurotechnology companies.  Paradromics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin.

Vice President of Clinical Affairs

Description

Paradromics

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