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• 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
Jana Care
View- Website:
- janacare.com
- Employees:
- 51
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Director Of Clinical And Regulatory AffairsJana Care Nov 2024 - PresentBoston, Massachusetts, Us -
Clinical Operations And Regulatory Support ConsultantVectis 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 -
Clinical Trial LeadMauna Kea Technologies Jan 2021 - Oct 2024Allston, 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 -
Clinical Research ManagerSeventh Sense Biosystems Nov 2019 - Dec 2020Medford, 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 -
Clinical Research ScientistSeventh Sense Biosystems Nov 2018 - Nov 2019Medford, 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 -
ScientistSeventh Sense Biosystems Mar 2016 - Nov 2018Medford, 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 -
EngineerSeventh Sense Biosystems Sep 2014 - Feb 2016Medford, Ma, Us -
Adjunct ProfessorWentworth Institute Of Technology Sep 2017 - Dec 2020Boston, Ma, UsTaught: Engineering Calculus I-III, Linear Algebra and Matrix Theory, and Multivariable Calculus -
Postdoctoral Research FellowMichigan Technological University Mar 2013 - Jan 2014Houghton, 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 -
Graduate Research AssistantMichigan Technological University Jan 2010 - Aug 2012Houghton, Mi, UsObjective: 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 -
Teaching Assistant- Chemical Engineering DepartmentMississippi State University Aug 2009 - Dec 2009Mississippi State, Ms, Us• Graduate level Process Computations, taught by Dr. Adrienne Minerick• Responsible for creating homework solutions and grading homeworks -
Tutor- Athletic Academics OfficeMississippi State University Jan 2009 - Dec 2009Mississippi 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 -
Graduate Research AssistantMississippi State University Aug 2007 - Dec 2009Mississippi State, Ms, UsI 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. -
Resident Assistant And Teaching Assistant- London Summer Program For EngineersUniversity Of Notre Dame Jun 2007 - Aug 2007Notre 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 -
Tutor- Academic Services For Student AthletesUniversity Of Notre Dame Aug 2006 - May 2007Notre Dame, In, Us• Tutored student athletes in mathematics (Calculus I thru Differential Equations)• Ran multi-student tutoring sessions in mathematics over school breaks -
Undergraduate Research AssistantUniversity Of Notre Dame Aug 2005 - May 2007Notre Dame, In, UsObjective: 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 -
Teaching Assistant- Mathematics DepartmentUniversity Of Notre Dame Aug 2005 - May 2007Notre 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
Kaela Leonard Education Details
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Michigan Technological UniversityChemical Engineering -
Mississippi State UniversityChemical Engineering -
University Of Notre DameChemical Engineering; Biomolecular Engineering -
Thayer AcademyHigh 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?
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What is Kaela Leonard's direct phone number?
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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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