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Summary

  • Clinical & Medical Affairs Professional, specializing in neuropharmacology, surgical biotech, biologics, and medical device.
  • Successfully moves across multiple therapeutic areas (Neurology/CNS, Surgery/OR, Hematology/Oncology, and Infection Prevention) and categories (pharmaceuticals, biologics, and medical device.) 
  • Cultivates and maintains relationships with internal and external stakeholders across multiple departments and institutions to facilitate collaboration and scientific exchange. 
  • Leverages clinical trial management experience to support clinical operations with company-sponsored clinical trials and requests for investigator-initiated studies.
  • Highly-effective communicator with over 15 years of experience in publishing and presenting scientific information. 
  • Extensive experience in project management and regulatory compliance.
  • Innovative problem-solver with excellent organizational, interpersonal, and leadership skills.

Professional Experience

20212023

Vice President, Clinical Research & Medical Affairs

Aerobiotix

Leads clinical research and medical affairs (C&M) activities to support the company's mission of improving overall safety in  operating rooms and other healthcare environments. .

  • Collaborates with cross-functional leadership (ie: R&D, commercial, quality, and regulatory) to develop integrated C&M strategies that align with and support key company initiatives.
  • Supports the generation of the preclinical & clinical evidence strategies to support clinical claims.
  • Designs, implements and manages post-marketing clinical studies to support and enhance company technologies. 
  • Develops and manages organization’s KOL program and medical advisory boards to glean valuable medical insights. 
  • Served as interim compliance officer; ensures that company activities are compliant with applicable requirements and participates in product claim approvals process.
  • Serves as scientific expert (internal and external) and contributes to the review and approval of all educational, promotional, and internal training material.  
  • Represents Aerobiotix at key external events and provides medical oversight for the scientific aspects of medical congresses and educational workshops. 
  • Develops and manages department budget.
20202021

Medical Science Liaison

Biogen

Develops and fosters purposeful relationships with key opinion leaders (KOLs) and HCPs in Alzheimer's Disease to provide unbiased clinical and scientific information, facilitate collaboration, and produce high value medical insights to support the company's medical strategy. 

  • Presents clinical and disease state information to KOLs/HCPs in multiple specialties (neurology, psychiatry, radiology, geriatrics, pharmacy, etc.)
  • National Lead for R&D-focused team, supporting both clinical and medical affairs activities
  • Participates in pre-launch activities and discussion of MSL team strategy 
  • Successfully utilizes technology to virtually engage KOLs/HCPs
  • Demonstrates cross-functional leadership through initiating/leading bi-weekly regional calls with internal stakeholders including commercial & medical value 
  • Served as a regional lead on the Veeva CRM system (appointed the 'Veeva Power User' for central region)
  • Organizes weekly calls with fellow MSLs from multiple regions to share best practices, review training materials, and discuss scientific literature/news
20192020

Medical Science Liaison

Axogen
  • Supported entire portfolio of products for peripheral nerve repair at various stages of the lifecycle including launch.  
  • Gathered, distilled, and presented relevant information from national and regional meetings to provide high value insights to cross-functional teams. 
  • Drove awareness and education regarding company technologies by presenting scientific data and contributing to scientific discussions at professional education events at the national and regional level. 
  • Contributed to medical strategic planning with cross-functional partners.
  • Supported the launch and expansion of a digital patient outreach initiative.  
  • Provided medical education and training to cross-functional colleagues
  • Assisted in the onboarding process for new MSLs
  • Successfully managed a large territory which encompassed the Central US
  • Experienced in working in a surgical environment and conducting cadaver labs. 
20182019

Clinical Trial Manager

Medpace

Led clinical trial teams (Phase I-III) and served as primary contact for all operational components of worldwide planning and execution in multiple therapeutic areas including CNS & sleep disorders, hematology/oncology, and rare disease.

  • Facilitated collaboration and effective communication by acting as a central liaison among the sponsor, CRO, PIs, KOLs, and vendors for all protocol interpretations and project-related issues.
  • Communicated operations strategy to ensure clarity of scope for clinical trial team and assures that functional area leadership appropriately understands milestones and accountability.
  • Coordinated project start-up, maintenance, and close-out activities.
  • Tracked patient and CRF status, safety issues, and timelines.
  • Provided oversight for CRAs and Project Coordinators on project team and mentored newly hired CTMs.
  • Provided input for study protocol, edit check specifications, data analysis plan, MDRGs, data clean-up results and analysis, and final study report. 
2018Present

Adjunct Assistant Professor

University of Cincinnati

Lectures on Principles of Pharmacology to PharmD students, as-needed. 

20162018

Postdoctoral Fellow

University of Cincinnati

Designed and implemented studies to assess the pharmacodynamic and pharmacokinetic aspects of psychostimulant and anti-cancer compounds.

  • Designed and managed multiple projects simultaneously.
  • Established project priorities and aligned timelines to maximize productivity. 
  • Facilitated collaborative research across 3 departments and 3 institutions.
  • Managed controlled substances to ensure compliance with DEA regulations.
  • Supervised the research activities of 2 graduate students by assigning laboratory responsibilities, coordinating experiments, and training them in laboratory techniques.
20092016

Graduate Research and Teaching Assistant

University of Cincinnati

Designed, executed, and communicated research focusing on the mechanisms and consequences of MDMA-induced neurotoxicity.

  • Research efforts resulted in 3 publications in peer reviewed journals.
  • Managed controlled substances to ensure compliance with DEA regulations.
  • Improved previously used protocols (microdialysis probe construction and implantation) which increased experimental success rate by 30%.
  • Communicated scientific information at lab meetings and departmental seminars.
  • Consistently earned top scores in oral communication skills on annual evaluation.
  • Presented novel scientific findings at local, regional, and national conferences.
  • Instructed a physiology lab section of ~ 30 PharmD students.

Education

20092016

Ph.D. in Pharmaceutical Sciences

University of Cincinnati

Concentration: Drug Development Sciences – Neuropharmacology

Dissertation: “MDMA and Glutamate: Implications for Hippocampal GABAergic Neurotoxicity.”

Additional Research:

  • "Gender Based Differences in Single Dose and Steady State Brain and Plasma Pharmacokinetics of Letrozole in Sprague-Dawley Rats."
  • “The Effect of Repeat Exposure to MDMA on the Function of the 5-HT Transporter in the Rat.”
20082009

M.S. in Physiology

Ball State University

Thesis: “Investigating the Binding of Monoclonal Antibody 10F5 in the Hearts of Lewis Rats.”

Additional Research:

  • “Cytosolic and Mitochondrial GSH Levels in the Rat Kidney Cortex and Medulla as a Function of Age.”
  • “Investigating the Binding of Monoclonal Antibody 10F5 in the Brains of Lewis Rats.”
20042008

B.S. in Sociology

Northern Kentucky University

Area of Concentration: Political Science and Pre-Medicine

Competencies

Scientific Expertise
  • Broad-based knowledge of the pharmacological and physiological aspects of many disease states, specializing in CNS.
  • Postdoctoral training in anti-cancer drug development.
Relationship Management
  • Facilitates collaborative efforts by developing strong relationships with internal and external stakeholders.
  • Builds constructive working relationships by encouraging cooperation and maintaining an environment of mutual respect.
Communication & Presentation
  • Proficient scientific writer with 6 peer-reviewed publications and 6 conference abstracts. 
  • Seasoned public speaker with experience in radio and  television interviews and  novel scientific findings at local, regional, and national conferences.. 
Project Management
  • Highly-efficient project manager able to design and manage multiple projects simultaneously.
  • Establishes project priorities and aligns timelines to maximize productivity.
  • Exceptional ability to coordinate collaborative research activities.
Regulatory Compliance
  • ICH and FDA GCP regulations
  • OIG Compliance Program
  • Sunshine Act 
  • AdvaMed Guidelines
  • PhRMA Code
Training and Development
  • Delivers in-depth scientific training to internal stakeholders. 
  • On-boards and mentors clinical research and medical affairs associates. 
  • Experienced classroom instructor who has taught in both academic and workplace environments .

Awards

  • Biogen BIG Award for Accountability (2020)
  • International P.E.O. Scholar Award Nominee (2014)
  • American Association of Pharmaceutical Scientists I/ODG Excellent Poster Award (2011)
  • Project accepted for the Graduate Summer Undergraduate Mentoring Program (2011)
  • Sigma Xi Scientific Research Society Grant (2009)
  • Ball State University ASPIRE Grant (2009)
  • Raymond E. Henzlik Physiology and Anatomy Research Award (2009)
  • Sigma Xi Poster Award (2009)
  • Keys/ Litten/ Smith Award for Outstanding Research (2009)

Professional Associations

  • Alzheimer's Association of Greater Cincinnati - Executive Leadership Team (Volunteer)
  • Association for Women in Science - Greater Cincinnati Chapter - Executive Board Member (Volunteer)
  • Medical Affairs Professional Society
  • Society for Neuroscience
  • American Association of Pharmaceutical Scientists

Publications

  • EM Pitzer, C Sugimoto, GA Gudelsky, CL Huff Adams, MT Williams, CV Vorhees. Deltamethrin Exposure Daily From Postnatal Day 3–20 in Sprague-Dawley Rats Causes Long-term Cognitive and Behavioral Deficits, Toxicological Sciences, 2019.
  • PD Arora, CL Huff Adams, GA Gudelsky, B DasGupta, PB Desai. Plasma and brain pharmacokinetics of letrozole and drug interaction studies with temozolomide in NOD-scid gamma mice and sprague dawley rats. Cancer Chemotherapy and Pharmacology, 2019.
  • CL Huff, RL Morano, JP Herman, BK Yamamoto, GA Gudelsky.  MDMA decreases glutamic acid decarboxylase (GAD) 67-immunoreactive neurons in the hippocampus and increases seizure susceptibility: Role for glutamate. Neurotoxicology, 2016.
  • SA Collins, CL Huff, N. Chiaia, GA Gudelsky, BK Yamamoto. MDMA Increases Excitability in the Dentate Gyrus: Role of 5HT2A Receptor Induced PGE2 Signaling. Journal of Neurochemistry, 2015.
  • R Gebhard, CL Huff, M Osborne, L Riegle and M. Kelly-Worden. Streptococcal Antibody Probe Crosses the Blood Brain Barrier and Interacts within the Basal Ganglia. Open Journal of Pathology, 2015.
  • CL Huff, N Bhide, A Schroering, BK Yamamoto, GA Gudelsky. Effect of repeated exposure to MDMA on the function of the 5-HT transporter as assessed by synaptosomal 5-HT uptake. Brain Research Bulletin, 2013.