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Vice President of Clinical Development and Regulatory Processes at Lung Biotechnology PBC and Lung Bioengineering Inc (subsidiaries of United Therapeutics Corporation)
Aimee Smart is an accomplished senior executive with more than 20 years of success in the pharmaceutical and biotechnology industries, Aimee enjoys leading deeply challenging projects where there is no clear path forward. She understands how to work with many people across various functions, operate under high pressure, and meet critical timelines to deliver results. And because everything she does in regulatory strategy, designing, and running clinical development programs is years in the making, her complex problem-solving ability includes considering the world of today while anticipating what might happen in the future.
In her current role of Vice President of Clinical Development and Regulatory Processes at LungBiotechnology PBC and Lung Bioengineering Inc (subsidiaries of United TherapeuticsCorporation), Aimee reports directly to the parent company CEO, driving clinical drug development and leading a multifunctional organization and a geographically dispersed team of ver 60 professionals, covering all aspects of development including; regulatory affairs, quality assurance, clinical development, product development, clinical supply, clinical operations, biostatistics and data management, and project management.
Aimee is part of the executive leadership team of United Therapeutics Corporation, representing her companies needs at the corporate level. She was responsible for Lung Biotechnology’sreorganization and setting its new strategic goals. And after leading the successful turnaround of the underperforming subsidiary to a respected, productive company, Aimee’s CEO asked he rto do it a second time and lead the Lung Bioengineering subsidiary.
During her more than 14-year tenure at Lung Biotechnology PBC, Aimee has served in increasingly senior clinical development, regulatory affairs and quality roles, including as Associate Vice President and Head of Office and Director, Global Regulatory Affairs. Her experience also includes regulatory affairs posts at VIRxSYS Corporation, Human GenomeSciences, Nabi Biopharmaceuticals, and Cato Research.
As much as she enjoys solving complex problems and driving results, Aimee is most passionate about ensuring that what she is doing is connected back to a meaningful mission that directly impacts people’s lives in a positive way.
Aimee earned her Bachelor of Science in Microbiology from North Carolina State University, where she was later honored with its Outstanding Young Alumni award. She completed her executive MBA from the University of Maryland in 2022 and was named one of the Best and brightest EMBA students by Poets & Quants magazine. In addition, Aimee holds certifications in Leadership Coaching for Organizational Performance from American University and in Regulatory Affairs for the U.S. and Europe from the Regulatory Affairs Professional Society.
She maintains professional memberships in the Drug Information Association, RegulatoryAffairs Professional Society, Women in Bio, and International Coach Federation. She also serves as a Member for the NCSU College of Sciences Foundations Board.
This is a rare opportunity to be the first Finance Team hire in our Maryland office to expand our UK-based finance team. As a US Finance Manager, you will be responsible for all-finance related activities in our US operations out of Maryland, ranging from financial accounting, management account to budgeting, financial planning and control. You will be responsible for building and growing the finance team and processes as we expand in the USA and work closely with the world-class science team based in Maryland. Having listed on NASDAQ in 2021, Vaccitech is growing rapidly both organically and though M&A and is excited to continue building its presence in the USA.
The Service Coordinator is the initial and primary point-of-contact for all DCM BioServices clients. They are responsible for interfacing with our clients and the DCM team to coordinate the delivery and reporting of all repairs and services. They also have a desire to provide the highest levels of client service, be an advocate for DCM BioServices, and be eager to drive growth.
In this role you will:
- Overall responsibility for the conduct of the assigned study as well as the interpretation, analysis, documentation, and reporting of results.
- Conducting the study in accordance with GLP regulations, the protocol, and Noble Life Sciences (NLS) SOPs.
- Defining: staffing, supplies, equipment, and space requirements for the study and assuring those test systems are as specified in the protocol.
- Notifying testing facility management which animal rooms and personnel will be required for the study.
- Preparing the study protocol and getting signed approval from the sponsor, testing facility manager, and pertinent subcontractors.
- Defining and coordinating subcontractor support requirements.
- Preparing IACUC documentation and submitting it to the IACUC committee for approval.
And Much More….
In this role you will:
- Serve as a Study Director for non-GLP and GLP-compliant non-clinical toxicology studies.
- Be responsible for study design and execution.
- Supervise of technical staff.
- Conduct data analysis and interpretation
- Prepare study reports in compliance with regulatory requirements.
- Study design, proposal preparation, and extensive interactions with sponsor representatives are essential functions.
- Other related duties as assigned.
In this role you will:
- Serve as a Study Director for non-GLP and GLP-compliant Medical Device efficacy and toxicology studies.
- Be responsible for study design and execution.
- Supervise of technical staff.
- Conduct data analysis and interpretation
- Prepare study reports in compliance with regulatory requirements.
- Study design, proposal preparation, and extensive interactions with sponsor representatives are essential functions.
- Other related duties as assigned.
Sr. Director of Business Development, Business Innovation Group (BIG), Canon U.S.A. Inc.
Ronald C. Kurz is the Senior Director / GM at Canon Virginia, Inc. (CVI), the Canon manufacturing, engineering, recycling and technical support center for the Americas located in Newport News, Virginia. Serving in a dual role, Ron is responsible for CVI’s Medical business including Sales, P&L, and Strategy. In addition, Ron is also responsible for the Business Development Division, including the development of strategic partnerships that leverage Canon Technology and Manufacturing Know-how. Prior to this position, he led the R&D division in the design and development of medical products for Canon BioMedical, Inc., which was a newly created Canon company. Ron has worked for Canon Virginia for more than 23 years.
Prior to joining Canon, Ron served as a Mechanical Design Engineer for nVIEW Corp, responsible for video projector design and as a Product Design Engineer for GE Aircraft controls, responsible for mechanical design and thermal / vibration analysis of Flight and Engine controls.
Ron holds multiple patents and has previously served on the Old Dominion University’s College of Engineering and Technology Advisory Board. He received his Bachelor of Science in Mechanical Engineering from Binghamton University.