Experience

National Institute of Allergy and Infectious Diseases (NIAID)

• United States
• Government Administration
• 700 & Above Employee

• IND Manager

  • Dec 2019 - Present

  Washington D.C. Metro Area • In collaboration with Division of AIDS (DAIDS) program staff, facilitate the development of regulatory strategies, assembles and submits Investigational New Drug (IND) applications to FDA, and maintain high quality IND applications. • Coordinate and participate in pre-IND meetings, including preparation of packages, scheduling of meetings, and follow-up with participants. • Develop, maintain, enhance, and modify DAIDS policies and standard operating procedures on IND… Show more • In collaboration with Division of AIDS (DAIDS) program staff, facilitate the development of regulatory strategies, assembles and submits Investigational New Drug (IND) applications to FDA, and maintain high quality IND applications. • Coordinate and participate in pre-IND meetings, including preparation of packages, scheduling of meetings, and follow-up with participants. • Develop, maintain, enhance, and modify DAIDS policies and standard operating procedures on IND matters. • Establish quality assurance standards and metrics for IND policies and procedures. • Coordinate and communicate with other DAIDS, NIAID, and NIH components to ensure consistency and harmonization of IND procedures, strategies, and best practices. • Advise DAIDS leadership on compliance with complex regulations and statutes impacting IND matters. • Provide guidance and training on IND regulations and procedures to DAIDS researchers and to domestic and international research organizations involved in DAIDS-sponsored clinical trials. • Develop and provide training to DAIDS staff on IND regulations and procedures in order to maintain consistency in approach and strategy and ensure compliance with regulations and guidelines. Show less



Technical Resources International, Inc.

• United States
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Regulatory Manager

  • May 2019 - Nov 2019

  Oversees the day-to-day regulatory operational activities for projects involving U.S. and non-U.S. Regulatory Health Authorities, including South Africa, Brazil, Canada, Zimbabwe, and Tanzania, with a team of ~20 Regulatory Specialists and Associates. Provides project management and regulatory support for Phase I - IV clinical trials, including performing final quality control review of all client deliverables and regulatory submissions to ensure adherence to client policies and… Show more Oversees the day-to-day regulatory operational activities for projects involving U.S. and non-U.S. Regulatory Health Authorities, including South Africa, Brazil, Canada, Zimbabwe, and Tanzania, with a team of ~20 Regulatory Specialists and Associates. Provides project management and regulatory support for Phase I - IV clinical trials, including performing final quality control review of all client deliverables and regulatory submissions to ensure adherence to client policies and country-specific health authority requirements and to assist in the resolution of deficiencies and problems as needed. Provides oversight for the tracking of regulatory activity, database maintenance, and ensures that records are complete, accurate, and current. Coordinates the maintenance of work process tools to promote efficiency and productivity, including drafting of templates, SOPs, work instructions, checklists, trackers, etc. Works with clients as the Regulatory Support Lead on Health Authority sponsor and site inspections, and inspection readiness activities, including ensuring compliance with requirements for the Sponsor Trial Master File (TMF). Represents clients at international and domestic annual conferences and sponsor network meetings, and works closely with collaborators, clinical research contractors, and other stakeholders to support the clients’ research mission. Leads and participates in client projects to optimize regulatory processes and facilitate best practice approaches to operationalize regulatory strategy.

• Regulatory Manager

  • Jan 2018 - May 2019

  Bethesda, MD Serves as the Project Manager for private sector clients, overseeing regulatory support activities for their rare disease drug development program. Coordinates the development, quality control, and submission of regulatory documents (New INDs, IND Annual Reports, Orphan Drug Requests, etc.), provides regulatory strategy guidance and regulatory intelligence, and manages the project team and budget.

• Scientific Review Committee Task Manager

  • Jun 2016 - May 2019

  • Manages a team responsible for technical and administrative support of a government client’s scientific review committees’ reviews of ~50 Phase I-IV clinical trials related to HIV/AIDS per year. • Ensures that protocol materials are received, tracked, and circulated in an accurate and timely manner, and that the committee meeting summaries and decision letters are prepared and distributed as per client approved procedures. • Prepares quarterly and annual contract deliverables. •… Show more • Manages a team responsible for technical and administrative support of a government client’s scientific review committees’ reviews of ~50 Phase I-IV clinical trials related to HIV/AIDS per year. • Ensures that protocol materials are received, tracked, and circulated in an accurate and timely manner, and that the committee meeting summaries and decision letters are prepared and distributed as per client approved procedures. • Prepares quarterly and annual contract deliverables. • Responsible for overseeing the development and maintenance of the Standard Operating Procedures (SOPs) that support the SRC operations. • Coordinates the development and implementation of resource tools for the client such as training seminars, user guides, and quick reference cards.

• Regulatory Specialist II

  • May 2015 - Dec 2017

  Bethesda, MD • Prepares, tracks and submits regulatory documents (in paper CTD and eCTD formats), including INDs, IND Annual Reports, Safety Reports, Food and Drug Administration (FDA) correspondence, protocols, and Investigator’s Brochures for >400 Phase I - IV clinical trials for >150 INDs for government and private sector clients. • Provides regulatory support for clinical protocols, including performing regulatory reviews to ensure compliance with Federal regulations. • Provides quality… Show more • Prepares, tracks and submits regulatory documents (in paper CTD and eCTD formats), including INDs, IND Annual Reports, Safety Reports, Food and Drug Administration (FDA) correspondence, protocols, and Investigator’s Brochures for >400 Phase I - IV clinical trials for >150 INDs for government and private sector clients. • Provides regulatory support for clinical protocols, including performing regulatory reviews to ensure compliance with Federal regulations. • Provides quality control review of regulatory documents. • Point of contact for reviewing and writing corporate and project-specific standard operating procedures (SOPs), new IND preparation, and regulatory review of clinical protocols.



The National Institutes of Health

• United States
• Biotechnology Research
• 700 & Above Employee

• Laboratory Technician 4, Contract

  • Sep 2014 - May 2015

  Bethesda, MD • Management of operations to plan quality assurance checks for direct reports and coordinate efforts with other leads. • Facilitate execution of compilation of written reports of audit findings from quality assurance checks for BSL-1 and BSL-2 laboratories. • Assist in the development of SOW for technicians conducting Operation Clean Sweep, an inventory audit of all NIH laboratories including the storage of biospecimens collected and stored long‐term under IRB‐approved clinical protocols… Show more • Management of operations to plan quality assurance checks for direct reports and coordinate efforts with other leads. • Facilitate execution of compilation of written reports of audit findings from quality assurance checks for BSL-1 and BSL-2 laboratories. • Assist in the development of SOW for technicians conducting Operation Clean Sweep, an inventory audit of all NIH laboratories including the storage of biospecimens collected and stored long‐term under IRB‐approved clinical protocols and other intramural repositories. • Review inventory records, reports, and documents associated with repository materials. Show less



The University of Georgia

• Higher Education
• 700 & Above Employee

• Graduate Student

  • Aug 2009 - May 2014

  Athens, GA • Investigated the adaptive regulation of Vitamin B1 transport and its involvement in multiple disease states including cancer, alcoholism, and neurological disorders. • Analyzed experimental data and synthesized 4 peer-reviewed publications reporting technical findings. • Instructed graduate-level labs on pharmacy skills that emphasized techniques in pharmaceutical compounding. • Taught and coordinated graduate level course focused on critiquing peer-reviewed scientific… Show more • Investigated the adaptive regulation of Vitamin B1 transport and its involvement in multiple disease states including cancer, alcoholism, and neurological disorders. • Analyzed experimental data and synthesized 4 peer-reviewed publications reporting technical findings. • Instructed graduate-level labs on pharmacy skills that emphasized techniques in pharmaceutical compounding. • Taught and coordinated graduate level course focused on critiquing peer-reviewed scientific literature. • Organized departmental seminar series covering a wide range of pharmaceutical topics. Show less



University of Dayton

• United States
• Higher Education
• 700 & Above Employee

• Undergraduate Researcher

  • Jan 2008 - May 2009

  Dayton, Ohio Area • Performed research relating to DNA replication and repair in Mycoplasma pneumoniae. • Worked as a team with other undergraduates on lab projects and presented scientific results in departmental and laboratory meetings. • Prepared a senior research thesis and hosted a student seminar presenting an overview of research performed.