Kaela Leonard

Kaela Leonard Email and Phone Number

Director of Clinical and Regulatory Affairs at Jana Care @ Jana Care
Newton, Massachusetts
Kaela Leonard's Location
Ayer, Massachusetts, United States, United States
Kaela Leonard's Contact Details

Kaela Leonard personal email

Kaela Leonard phone numbers

About Kaela Leonard

• Currently the Clinical Trial Lead – US for Mauna Kea Technologies, a medical device company that makes an adjunct technology for use in endoscopy procedures. In charge of the US based clinical trials.• 6+ years experience in Clinical Affairs/Operations• Previously managed clinical operations for Seventh Sense Biosystems from design of trials, management of day-to-day trial operations and analysis of data post-trial• 10+ years experience in microdevice design and fabrication, biological sample handling and experimental design• Earned PhD in Chemical Engineering from Michigan Technological University in August 2012• Dissertation focused on microfluidics, electrokinetics and human erythrocytes. Specifically my research is aimed at creating a microdevice that could rapidly test for a human's blood type using only a drop of blood and taking a matter of minutes.• Mentored 17 undergraduates during graduate school and post-doc years• Participation in University of Notre Dame’s Abroad Program for Engineers in London fed passion for globalizationSpecialties: Clinical research, clinical trial design and management, analysis of clinical data, microdevice fabrication via soft photolithography, dielectrophoresis, human erythrocytes, electrokinetics, lab on a chip devices

Kaela Leonard's Current Company Details
Jana Care

Jana Care

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Director of Clinical and Regulatory Affairs at Jana Care
Newton, Massachusetts
Website:
janacare.com
Employees:
51
Kaela Leonard Work Experience Details
  • Jana Care
    Director Of Clinical And Regulatory Affairs
    Jana Care Nov 2024 - Present
    Boston, Massachusetts, Us
  • Vectis Solutions Llc
    Clinical Operations And Regulatory Support Consultant
    Vectis Solutions Llc May 2022 - Present
    • Provide clinical support for customers looking to acquire human biologic samples• Interface with customers to determine sample needs and requirements• Conduct data analysis support and copy writing for EUA and FDA submissions for client’s existing product• Develop customer specific clinical investigation documents such as informed consent, protocol, and case report forms
  • Mauna Kea Technologies
    Clinical Trial Lead
    Mauna Kea Technologies Jan 2021 - Oct 2024
    Allston, Ma, Us
    • Successfully led US based clinical trials in pulmonology, navigating numerous involved parties and ensuring study completion• Oversees the setup of study sites in the US including device training, protocol training, and compliance with protocol requirements• Participates in study results analysis• Provides support for French-based team with European-specific activities such as CE mark renewal• Ensure adherence of clinical studies with company SOPs• Interfaces with global marketing and US-based sales team on US based clinical activities• Active participant in cross-departmental discussions involving product improvement and new product development
  • Seventh Sense Biosystems
    Clinical Research Manager
    Seventh Sense Biosystems Nov 2019 - Dec 2020
    Medford, Ma, Us
    • Led investigation into alternative material option, requiring iterative interaction with potential vendors as well as with manufacturing team with input from marketing• Responsible for protocol development for FDA appropriate trials and clinical sections of FDA submission• Primary interface with IRB, principal investigators, and medical monitors• Managed study sites including setup, data collection and data output• Responsible for vendor and timeline management• Responsible for data integrity and accuracy throughout the clinical trial lifecycle• Actively participated in board meetings
  • Seventh Sense Biosystems
    Clinical Research Scientist
    Seventh Sense Biosystems Nov 2018 - Nov 2019
    Medford, Ma, Us
    • Led usability studies to build data set for self-collection 510k submission to FDA, ultimately leading to successful 510k clearance in November 2019• Led day-to-day operations of clinical testing of device prototypes• Responsible for the training of clinical staff according to GCP standards
  • Seventh Sense Biosystems
    Scientist
    Seventh Sense Biosystems Mar 2016 - Nov 2018
    Medford, Ma, Us
    • Led investigation into alternative material option• Developed system for anticoagulating blood during collection with novel blood collection technique (TAP system)• Determined testing procedures for ensuring that blood quality meets necessary standards• Performed clinical testing of device prototypes on human volunteers and assessing device performance and collected blood quality.• Documented experiments to enable the integration of research findings into device development in preparation for FDA submission• Interfaced with design and development team through design review and device feedback• Wrote procedures for anticoagulant preparation and deposition into device
  • Seventh Sense Biosystems
    Engineer
    Seventh Sense Biosystems Sep 2014 - Feb 2016
    Medford, Ma, Us
  • Wentworth Institute Of Technology
    Adjunct Professor
    Wentworth Institute Of Technology Sep 2017 - Dec 2020
    Boston, Ma, Us
    Taught: Engineering Calculus I-III, Linear Algebra and Matrix Theory, and Multivariable Calculus
  • Michigan Technological University
    Postdoctoral Research Fellow
    Michigan Technological University Mar 2013 - Jan 2014
    Houghton, Mi, Us
    • Entrepreneurial Lead for National Science Foundation I-Corps team; won top award in cohort• Designed business canvas model for start-up company developing a medical device to determine ABO-Rh blood type based on the fundamental work done in my PhD research• Involved cost analysis, market research for competitors, partners and customers • Conducted over 100 customer discovery interviews with potential customers, partner, suppliers and competition in a 7-week period.• Recommended path forward for start-up company based on insights gained during customer discovery interviews• Transformed the design of a microfluidic device enabling the transition from laboratory research to a viable commercial product
  • Michigan Technological University
    Graduate Research Assistant
    Michigan Technological University Jan 2010 - Aug 2012
    Houghton, Mi, Us
    Objective: To create a custom-fabricated microdevice that can be used to test for the ABO-Rh blood type of an unknown sample by way of subjecting the sample to an alternating current dielectrophoretic field.Researching AC Dielectrophoresis in medical micro-devices: • Exploring theoretical connection between Dielectrophoresis and Maxwell-Wagner Membrane Relaxations • Completed a study of the rupturing rates of human erythrocytes when subjected to 1kHz alternating current dielectrophoretic field• Studying the movement of erythrocytes in a 1MHz AC field as well as the movement of modified erythrocytes (without the ABO-Rh antigens)• Determining a method for removing the ABO-Rh antigens from the human erythrocytes• Exploring the change in dielectrophoretic cross-over frequency based on blood typeDesign and fabricate microdevices:• Pattern on Si wafers using soft photolithography and a UV mask aligner in a clean room environment. • Design and fabricate plated electrodes using a six inch sputter system and soft photolithography techniquesExperimental design & Analysis of data:• Image analysis via customized Zeiss Automeasurement Software program• Statistical analysis, scaling, image manipulationTrained in safety precautions for a BSL2 lab:• Biosafety Cabinet, Centrifuge, Plasma generator, etc.Mentoring 4 undergraduate researchers on individual erythrocyte electrokinetic projects14 presentations, 3 papers and 8 awards
  • Mississippi State University
    Teaching Assistant- Chemical Engineering Department
    Mississippi State University Aug 2009 - Dec 2009
    Mississippi State, Ms, Us
    • Graduate level Process Computations, taught by Dr. Adrienne Minerick• Responsible for creating homework solutions and grading homeworks
  • Mississippi State University
    Tutor- Athletic Academics Office
    Mississippi State University Jan 2009 - Dec 2009
    Mississippi State, Ms, Us
    • Tutored 2 student-athletes to SouthEastern Conference All-Scholastic Honors (Spring 2009)• Tutored various student athletes in all subject areas, mentoring them to excel in both academics as well as athletics• Learned various study techniques to assist students• Learned to motivate and teach student athletes
  • Mississippi State University
    Graduate Research Assistant
    Mississippi State University Aug 2007 - Dec 2009
    Mississippi State, Ms, Us
    I was a PhD candidate at Mississippi State University studying the effect of an alternating current dielectrophoretic field on human erythrocytes in a medical microdevice until I transferred with my advisor to Michigan Technological University.
  • University Of Notre Dame
    Resident Assistant And Teaching Assistant- London Summer Program For Engineers
    University Of Notre Dame Jun 2007 - Aug 2007
    Notre Dame, In, Us
    • Responsible for 40 students as they spent 6 weeks studying in London, UK (resident safety and knowledge of the city)• Teaching Assistant for “Energy and Society” taught by Dr. Frank Incropera
  • University Of Notre Dame
    Tutor- Academic Services For Student Athletes
    University Of Notre Dame Aug 2006 - May 2007
    Notre Dame, In, Us
    • Tutored student athletes in mathematics (Calculus I thru Differential Equations)• Ran multi-student tutoring sessions in mathematics over school breaks
  • University Of Notre Dame
    Undergraduate Research Assistant
    University Of Notre Dame Aug 2005 - May 2007
    Notre Dame, In, Us
    Objective: To stabilize liposome formation with calcium phosphate and encapsulate polystyrene molecules with these liposomes. (Research Advisor: Dr. Elaine Zhu)• Designed and implemented project based on the synthesis and stabilization of liposomes• Assisted graduate students with their research• Trained graduate and undergraduate students on the confocal microscope
  • University Of Notre Dame
    Teaching Assistant- Mathematics Department
    University Of Notre Dame Aug 2005 - May 2007
    Notre Dame, In, Us
    • Homework grading for Differential Equations in the Fall of 2005• Conducted two weekly help sessions in the Spring of 2006 • Teaching assistant for Business Calculus II

Kaela Leonard Skills

Chemical Engineering Microfluidics Experimentation Matlab Characterization Photolithography Scanning Electron Microscopy Comsol Statistics Microfabrication Spectroscopy Labview Research Microsoft Office Autocad Confocal Microscopy Electrophoresis Design Of Experiments Medical Devices Engineering Research And Development Sputtering Electrokinetics Transparency Photoplotting Data Analysis

Kaela Leonard Education Details

  • Michigan Technological University
    Michigan Technological University
    Chemical Engineering
  • Mississippi State University
    Mississippi State University
    Chemical Engineering
  • University Of Notre Dame
    University Of Notre Dame
    Chemical Engineering; Biomolecular Engineering
  • Thayer Academy
    Thayer Academy
    High School Diploma

Frequently Asked Questions about Kaela Leonard

What company does Kaela Leonard work for?

Kaela Leonard works for Jana Care

What is Kaela Leonard's role at the current company?

Kaela Leonard's current role is Director of Clinical and Regulatory Affairs at Jana Care.

What is Kaela Leonard's email address?

Kaela Leonard's email address is ka****@****ail.com

What is Kaela Leonard's direct phone number?

Kaela Leonard's direct phone number is +161754*****

What schools did Kaela Leonard attend?

Kaela Leonard attended Michigan Technological University, Mississippi State University, University Of Notre Dame, Thayer Academy.

What skills is Kaela Leonard known for?

Kaela Leonard has skills like Chemical Engineering, Microfluidics, Experimentation, Matlab, Characterization, Photolithography, Scanning Electron Microscopy, Comsol, Statistics, Microfabrication, Spectroscopy, Labview.

Who are Kaela Leonard's colleagues?

Kaela Leonard's colleagues are Tim Richards, Kavitha D S, Pooja Negi, Byregowda R K Gowda, Shivakumar C, Rahul Tikate, Daniel Lookadoo.

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