Summary
Overview
Work History
Education
Skills
Publications
Timeline
Generic

Stephanie Washburn

Southlake

Summary

Seasoned Clinical and Medical Affairs Executive with nearly 20 years of experience in medical device innovation, clinical research strategy, and regulatory alignment. Adept at building clinical evidence portfolios, leading cross-functional teams, and accelerating time-to-market for emerging therapies. Recognized for ability to translate complex science into actionable strategy, cultivate high-performing teams, and drive value for investors, regulators, and patients alike. Therapeutic expertise in neuromodulation, migraine, chronic pain, substance use disorders, and mental health.

Overview

18
18
years of professional experience

Work History

VP, Strategy & Solutions

Moxie Clinical
03.2025 - Current
  • Lead strategic development and solution delivery at a boutique CRO specializing in neuroscience and medtech innovation.
  • Collaborate directly with startup founders, investors, and clinical stakeholders to design trial-ready programs that align with regulatory and funding milestones.
  • Spearhead customized clinical and regulatory strategies, leveraging deep therapeutic expertise to accelerate timelines and de-risk product development.
  • Drive strategic partnerships, business development initiatives, and service innovation to expand market reach and client value.
  • Develop scalable frameworks for clinical readiness and regulatory alignment tailored to early-stage medtech companies.
  • Lead cross-functional collaboration across medical writing, data management, and operations to streamline study design and execution.
  • Advise on U.S. and international trial strategies, including first-in-human and pivotal studies.
  • Build strategic alliances with CRO partners, academic centers, and service providers to extend capabilities.
  • Play a key role in positioning client companies for investor funding, acquisition, or regulatory engagement.

Head of Clinical and Medical Affairs Strategy

Senseye, Inc.
09.2023 - 04.2024
  • Provided executive oversight for all clinical and medical affairs programs at a software as a medical device (SaMD) startup.
  • Built and led the clinical trial operations function, including medical writing and vendor management.
  • Established scalable infrastructure, SOPs, and quality systems to support global study execution and regulatory readiness.
  • Collaborated closely with R&D and therapeutic area leaders to prioritize studies and align operational strategy with scientific goals.
  • Designed and implemented clinical operations model supporting feasibility, budgeting, contracting, and compliance.
  • Developed end-to-end clinical processes ensuring timely execution and alignment with QMS and regulatory standards.
  • Oversaw vendor selection and performance, budget forecasting, and cross-functional timelines.
  • Provided strategic input into protocol development and post-approval lifecycle planning.

Founder & Principal Consultant

Regenesis Health LLC
01.2014 - 09.2023

Established and led a consulting practice delivering end-to-end clinical and medical affairs services to early-stage and growth-phase medical device companies. Supported commercialization and regulatory strategies through the design and execution of clinical trials across diverse therapeutic areas, including orthopedics (implantable spine), peripheral vascular disease, and cardiovascular surgical devices.

  • Directed clinical research project teams and provided hands-on execution of trial planning, vendor management, and study oversight.
  • Developed statistical analysis plans, conducted data analyses, authored clinical study reports, and wrote Clinical Evaluation Reports (CERs) compliant with MEDDEV 2.7.1 Rev 4.
  • Created customized clinical evidence strategies aligned with client business objectives and regulatory requirements.
  • Managed IRB submissions, site feasibility, patient recruitment strategies, and data infrastructure planning.
  • Authored peer-reviewed publications, developed publication plans, and supported scientific communications.
  • Secured contracts with three separate organizations through targeted relationship-building and domain expertise.
  • Successfully led a clinical study with a budget exceeding $1 million.

Senior Clinical Research Scientist

PainTEQ, Inc.
11.2022 - 09.2023

Responsible for leading a team of clinical research scientist consultants with diverse responsibilities including clinical trial management and closeout, clinical research representation on product development teams, clinical research protocol development, assimilating medical information to key opinion leaders and other healthcare professionals, scientific/medical communications including development of publication strategies, drafting and submitting abstracts, posters, and manuscripts as well as presenting research study findings at national conferences. Key accomplishments include:

  • Study close-out of complicated trial

Vice President, Clinical and Medical Affairs

Spark Biomedical
03.2021 - 03.2022
  • Directed clinical operations strategy and execution for an innovative neurostimulation company focused on opioid withdrawal treatment. Oversaw all aspects of clinical trial design, planning, and delivery to ensure alignment with regulatory and commercialization milestones.
  • Led end-to-end clinical trial processes, ensuring adherence to timelines, budgets, and quality standards.
  • Authored operational components of protocols and managed site identification, selection, and oversight.
  • Collaborated cross-functionally on integrated development plans, including protocol development and data management.
  • Built and maintained key relationships with CROs, investigators, and external experts to ensure successful trial execution.
  • Delivered high-quality clinical data packages to support FDA submissions and regulatory interactions.
  • Oversaw creation of CRFs, clinical study reports, and statistical collaboration to support trial integrity and reporting.

Medical Science Liaison (contract)

Tardis Medical
06.2018 - 03.2019

Served as the primary scientific liaison between electroCore and the neurology/headache medicine community for the gammaCore device, a non-invasive vagus nerve stimulator for migraine and cluster headache. Engaged with healthcare professionals to facilitate clinical education, scientific exchange, and evidence-based adoption.

  • Identified and cultivated relationships with Key Opinion Leaders (KOLs) in neurology and headache medicine.
  • Delivered scientific presentations and engaged in meaningful clinical discussions at national, regional, and local meetings.
  • Supported field-based scientific communication to drive awareness and understanding of device mechanisms and clinical data.
  • Bridged communication between internal teams and external stakeholders to inform strategy and gather insights from the field.

Principal Scientist

Abbott, formerly St. Jude Medical Inc.
03.2017 - 07.2017

Led clinical evidence generation initiatives and served as a key scientific contributor across multiple clinical programs within the neuromodulation portfolio.

  • Authored and reviewed clinical study documents, protocols, and regulatory submissions including PMAs and clinical study reports.
  • Provided scientific guidance on trial design, protocol development, and statistical analysis plans as an active study team member.
  • Synthesized competitive intelligence and literature to inform strategy across multiple therapeutic areas.
  • Directed publication planning and led the development of abstracts, posters, and manuscripts in collaboration with investigators.
  • Acted as lead reviewer for physician-initiated studies and supported FDA interactions through targeted dossier preparation.
  • Drove clinical evidence strategies to support product development, market positioning, and regulatory success.

Senior Clinical Affairs Manager

St. Jude Medical, Inc.
10.2015 - 03.2017

Led the design, execution, and oversight of pre- and post-market clinical trials for neuromodulation therapies, ensuring compliance with regulatory standards and alignment with business objectives.

  • Designed and managed clinical studies to support product development, marketing, and regulatory submissions.
  • Collaborated with R&D and marketing to inform new product development and commercial strategy.
  • Developed launch materials, trained national sales teams, and supported KOL engagement and scientific communication.
  • Provided strategic input for publications, investigator meetings, and public presentations.
  • Interfaced with regulatory authorities and supported IDE and post-approval study submissions.
  • Activated 12 clinical sites in 3 months through strong relationship management.
  • Authored IDE post-approval study protocol resulting in FDA approval.

Director, Clinical Research

ImThera Medical, Inc.
01.2015 - 10.2015

Led the execution of clinical trial strategy for an implantable device targeting sleep apnea. Oversaw site evaluation, selection, initiation, and close-out while ensuring regulatory compliance and data integrity.

  • Provided hands-on support to clinical sites, investigators, and coordinators to ensure protocol adherence and high-quality data collection.
  • Resolved site-level challenges efficiently and ensured timely monitoring and documentation of study progress.
  • Successfully configured electronic data capture (EDC) system and developed study worksheets by fostering strong vendor partnerships.
  • Initiated 18 clinical sites within 4 months through proactive relationship-building and operational coordination.

Manager, Scientific Affairs and Communications

St. Jude Medical
01.2012 - 01.2014
  • Developed and managed the scientific communications team responsible for overseeing all abstracts, posters and manuscripts created within the division as well as the physician-initiated study proposal process. Key accomplishments include:
  • Strategic alignment of publication plan with business initiatives.
  • Significantly increased the number of published manuscripts created within the division year over year.
  • Successful communication of key study results at scientific/medical conferences, establishing the organization as a leader in clinical research.

Senior Clinical Research Scientist

St. Jude Medical
10.2009 - 01.2011
  • Responsible for leading a team of clinical research scientists with diverse responsibilities including clinical research representation on product development teams, preclinical research development, implementation and management, clinical research protocol development, assimilating medical information to key opinion leaders and other healthcare professionals in the role of clinical science liaison, scientific/medical communications including development of publication strategies, drafting and submitting abstracts, posters, and manuscripts as well as presenting research study findings at national conferences. Authored CERs. Key accomplishments include:
  • Drafted regulatory documents and responded to questions from FDA resulting in 510(k) approval of a novel lead delivery system.
  • Drafted regulatory documents and responded to questions from TUV resulting in approval (CE mark) of peripheral nerve stimulation system for the management of intractable chronic migraine.
  • Researched and identified appropriate preclinical migraine model, determined appropriate outcome measures, identified contract laboratory and finalized contract for conduction of preclinical migraine study.
  • Provided scientific expertise on development and implementation of the diabetic peripheral neuropathy, traumatic brain injury, and spinal cord stimulation/peripheral nerve stimulation IDE studies, intractable chronic migraine international registry, and the Epiducer lead delivery system observational study including protocol and case report form review.
  • Provided scientific expertise on content of the final report of the peripheral nerve field pilot study.
  • Developed and implemented clinical science liaison program to facilitate successful physician interactions with clinical research team.

Clinical Research Scientist

Clinical Research Scientist
10.2008 - 10.2009
  • Served as clinical research representative on product development teams. Developed, implemented and managed preclinical research projects. Provided input into design and appropriate outcome measures for clinical research protocols for both pre- and post-market studies. Assimilated scientific/medical information to key opinion leaders and other healthcare professionals. Drafting and submitted abstracts, posters, and manuscripts. Presented research study findings at national conferences. Performed literature reviews for regulatory submissions and internal guidance. Wrote reports for regulatory submissions for product approval. Worked with healthcare professionals on the development of study ideas and clinical research protocols. Reviewed physician-initiated study proposals to determine the feasibility and importance of the proposed research. Authored CERs.

Clinical Monitor

Clinical Monitor
10.2007 - 10.2008
  • Planned, organized and coordinated clinical studies. Identified, selected, initiated and closed out appropriate study sites for clinical studies. Developed assigned investigational plans (including clinical protocol, case report forms, and all required documents). Performed investigator training, site audits, and reports progress of the clinical studies. Assured study compliance to study protocol, domestic and international good clinical practices (GCPs) guidelines and standard operating procedures (SOPs). Trained clinical site personnel and investigators. Assured study compliance and that all safety information was reported appropriately. Maintained communication with sites. Presented clinical study updates and summaries in written and oral reports. Monitored (initiation, periodic and close-out visits) all clinical studies according to written GCPs and SOPs.

Education

Doctor of Philosophy - Psychology (Behavioral & Cellular Neuroscience)

Texas A&M University
College Station, TX
01.2007

Master of Science - Psychology (Behavioral & Cellular Neuroscience)

Texas A&M University
College Station, TX
01.2005

Bachelor of Science - Psychology

Texas A&M University
College Station, TX
01.2001

Skills

  • Team leadership
  • Relationship building
  • Decision-making
  • Critical thinking
  • Complex Problem-solving
  • Strategic planning
  • Results-driven
  • Data analysis
  • Budget oversight
  • Partnerships and affiliations
  • Lead generation
  • Rules and regulations
  • Proposal writing

Publications

  • Skaribas IM, Washburn SN. Successful treatment of Charcot-Marie-Tooth chronic pain with spinal cord stimulation: A case-study. Neuromodulation. 2010; 13: 224-228.
  • Logé D, De Coster O, Washburn SN. Technological innovation in spinal cord stimulation: Use of a newly developed delivery device for introduction of spinal cord stimulation leads. Neuromodulation. 2012; 15: 392-401.
  • Silberstein SD, Dodick DW, Saper J, Huh B, Slavin KV, Sharan A, Reed K, Narouze S, Mogilner A, Goldstein J, Trentman T, Vaisman J, Ordia J, Weber P, Deer T, Levy R, Diaz RL, Washburn SN, Mekhail N. Safety and efficacy of peripheral nerve stimulation of the occipital nerves for the management of chronic migraine: results from a randomized, multicenter, double-blinded, controlled study. Cephalalgia. 2012; 32: 1165-1179.
  • Washburn SN, Catlin R, Bethel K, Canlas B. Patient perceived differences between constant current and constant voltage spinal cord stimulation systems. Neuromodulation. 2014; 17(1): 28-35.
  • Deer TR, Skaribas, IM, Haider N, Salmon J, Kim CH, Nelson C, Tracy J, Espinet A, Lininger TE, Tiso RL, Archacki MA, Washburn SN. Effectiveness of Cervical Spinal Cord Stimulation for the Management of Chronic Pain. Neuromodulation. 2014; 17(3): 265-71.

Timeline

VP, Strategy & Solutions

Moxie Clinical
03.2025 - Current

Head of Clinical and Medical Affairs Strategy

Senseye, Inc.
09.2023 - 04.2024

Senior Clinical Research Scientist

PainTEQ, Inc.
11.2022 - 09.2023

Vice President, Clinical and Medical Affairs

Spark Biomedical
03.2021 - 03.2022

Medical Science Liaison (contract)

Tardis Medical
06.2018 - 03.2019

Principal Scientist

Abbott, formerly St. Jude Medical Inc.
03.2017 - 07.2017

Senior Clinical Affairs Manager

St. Jude Medical, Inc.
10.2015 - 03.2017

Director, Clinical Research

ImThera Medical, Inc.
01.2015 - 10.2015

Founder & Principal Consultant

Regenesis Health LLC
01.2014 - 09.2023

Manager, Scientific Affairs and Communications

St. Jude Medical
01.2012 - 01.2014

Senior Clinical Research Scientist

St. Jude Medical
10.2009 - 01.2011

Clinical Research Scientist

Clinical Research Scientist
10.2008 - 10.2009

Clinical Monitor

Clinical Monitor
10.2007 - 10.2008

Master of Science - Psychology (Behavioral & Cellular Neuroscience)

Texas A&M University

Bachelor of Science - Psychology

Texas A&M University

Doctor of Philosophy - Psychology (Behavioral & Cellular Neuroscience)

Texas A&M University