Job experience

• September 2023 - September 2024
  PHARMACOKINETICIST/REVIEWER
  Food and Drug Administration
  

  Silver Spring, MD

  • Conducted the scientific evaluation of generic drug products and determined the acceptability of scientific and regulatory applications through the assessment and evaluation of Abbreviated New Drug Applications (ANDAs) submissions following an established process and within a specific timeline.
  • Evaluated in-vitro, pharmacokinetic (PK), and/or clinical endpoint bioequivalence studies related to scientific aspects of bioequivalence data submitted as it relates to generic drugs and the areas of pharmacokinetics including drug absorption, disposition, metabolism and elimination as well as and pharmacodynamic assays.
  • Provided recommendations for approval or identified deficiencies or the need for additional data in ANDAs, amendments, and supplements.
  • Assessed safety findings from bioequivalence studies and acceptability of inactive ingredient levels, user interfaces in support of ANDAs.
  • Participated in the Office of Bioequivalence Pediatric Excipient Evaluation Working Group to gather information for a database of excipients used in pediatric formulation evaluation of ANDAs.

• May 2021 - August 2023
  RESEARCH/ONCOLOGY CLINICAL PHARMACIST
  MedStar Georgetown University Hospital
  

  Washington, DC

  • Responsible for pharmacy setup, which includes review of clinical trial documents (protocol, pharmacy manual, investigator brochure), correspondence with sponsor or clinical trials team to initiate the trial, build protocol specific medication order forms, prepare concise written instructions for dispensing, and development of an estimated pharmacy budget.
  • Prepared, compounded, and dispensed investigational drugs and materials issued by the Investigational Drug Service for ongoing research studies.
  • Participated in site initiation visits, interim monitoring visits and close out visits for clinical trials.
  • Performed a thorough review and update of current research pharmacy’s standard operating procedures as necessary.
  • Responsible for drug management, accountability and regulatory support for clinical trials.
  • Managed required record-keeping, shipping, ordering, and inventory activities.
  • Ensured the accuracy and integrity of products prior to their delivery to clinical trial subjects.
  • Reviewed chemotherapy orders for appropriateness of therapy, drug, route, frequency and duration according to the hospital’s chemotherapy policy.
  • Reviewed patient’s medication profile for possible drug reactions, duplication of orders and contraindications, and consult with physician appropriately.
  • Ensured proper technique and accurate preparation of all pharmaceutical products, including oral, IV admixtures, chemotherapeutic, and investigational agents and ensure the use of proper drug solution, labeling, and packaging.
  • Participated in oncology pharmacy on-call services during evening hours, weekends and holidays to assist hospital staff with any patient-care related questions regarding inpatient/outpatient chemotherapy and research drugs.
  • Delegated appropriate tasks/duties to pharmacy technicians.
  • Precepted student pharmacists.

• August 2019 - May 2021
  CLINICAL PHARMACIST I
  MedStar Washington Hospital Center
  

  Washington, DC

  • Performed medication order processing responsibilities within established policies, procedures and guidelines and provide drug information while applying a thorough understanding and knowledge of drug and medical therapy
  • Evaluated and dispensed medication orders, supervised central compounding, prepared IV admixtures and compound sterile products
  • Checked for accuracy of all medication/prescriptions prepared by the technical staff prior to dispensing the medication to the patient and made appropriate corrections when necessary
  • Dispensed controlled substances and maintained perpetual inventory of controlled substances, assuring legal requirements and departmental policies and procedures are consistently followed
  • Provided functional supervision for support personnel. Monitored attendance and work quality, prioritize resources based on workload and productivity, and directed the work flow of support personnel to ensure departmental standards and time frames are met
  • Prepared and distributed COVID-19 vaccines for patients at the COVID Vaccination Clinic
  • Trained new pharmacists

• January 2019 - May 2020
  REMOTE CONSULTANT PHARMACIST
  Case Haub Consulting
  

  West Des Moines, IA

  • Delivered medication therapy management (MTM) services, including but not limited to, comprehensive medication reviews, targeted medication reviews, medication reconciliation and clinical interviews to assess appropriateness of all medications, identify barriers to adherence, optimize medication therapy and to improve clinical outcomes
  • Identified, resolved, and prevented medication-related problems including: untreated indications, medication without indication, improper drug selection, subtherapeutic dosage, overdose, failure to receive medication, adverse drug reactions, and drug interactions
  • Provided patient education related to the patient’s disease state, including side effects, reasons for proper compliance, and any special instructions
  • Communicated medication therapy optimization recommendations to prescribers effectively and professionally

• August 2013 - January 2019
  CLINICAL PHARMACIST
  Mirixa Corporation
  

  Reston, VA, USA

  • Responsible for performing comprehensive and targeted medication reviews to identify, resolve, and prevent medication-related problems
  • Provided clinical recommendations pertaining to adverse drug reactions, high risk medications, drug interactions, adherence, gaps in care, therapeutic substitution and generic substitution
  • Communicated professionally and discuss/document clinical recommendations to prescribers and interdisciplinary care teams and optimized medication use for improved patient outcomes
  • Participated in annual audit monitoring process by Medicare Part D/Medicaid health plans or other MTM partners
  • Assisted with clinical/product development projects as directed by the Vice President of Clinical Product Marketing
  • Trained new pharmacists/non-pharmacist staff
  • Mentored student pharmacists during Advanced Pharmacy Practice Experience rotations

• August 2005 - August 2009
  SR. RESEARCH PROGRAM COORDINATOR/CLINICAL RESEARCH REGULATORY SPECIALIST
  Johns Hopkins Hospital
  

  Baltimore, MD, USA

  • Monitored the clinical course and collection of research data on patients entered onto research protocols at the Sidney Kimmel Comprehensive Cancer Center (SKCCC) and participating sites. Responsible for organization, entry, maintenance and accuracy of all clinical research data for complex and detailed phase I – III clinical trials
  • Ensured that studies are conducted according to all applicable regulations and guidelines and identified areas for improvement in study protocols and suggested implementation of changes
  • Prepared all necessary forms and collect paperwork related to research protocols, regulatory submissions including: FDA Form 1572, collection of CVs, medical licenses, financial disclosure forms and conflict of interest documents if applicable. Prepared and submitted protocol revisions, renewals and any adverse event (AE) and serious adverse event (SAE) reports to Institutional Review Board and Western Institutional Review Board
  • Developed and maintained a protocol specific database, case report forms or spreadsheet for tracking patient activity and data analysis. Corrected errors in database when necessary
  • Prepared reports on individual patients and descriptive statistics for the protocol as required by the principal investigator, program manager, sponsor or FDA. Responded in a timely manner to special projects or queries related to the data
  • Prepared for and participated in audits of studies at SKCCC or outside audit requirements. Wrote audit summary reports and responses with input from the program manager, principal investigator and other clinical research staff
  • Trained and educated new staff or less senior research staff in protocol, clinical research and database information

• January 2001 - December 2004
  SR. CLINICAL RESEARCH ASSISTANT
  Vanderbilt University Medical Center
  

  Nashville, TN, USA

  • Provided technical support for clinical research studies related to protocols pertaining to cardiovascular disease. Prepared protocol specific experiments, performed large/small animal anesthesia and animal surgical procedures. Collected, analyzed, and interpreted experimental data in preparation for publication
  • Assisted in submitting the Institutional Animal Care and Use Committee (IACUC) and Institutional Review Board (IRB) protocols necessary for approval and renewal
  • Created and maintained cardiac surgery database by extracting and reviewing information from patient’s medical records. Interfaced with data management group to perform statistical analysis of data for presentation and journal article publication. Responsible for submitting Society of Thoracic Surgeons database inquiries to The Society of Thoracic Surgeons
  • Coordinated student volunteer program. Instructed, trained and supervised more than 30 medical students/volunteers in general experiment protocols, operation of laboratory equipment, products and basic surgical techniques. Scheduled and conducted interviews for new students/volunteers. Responsible for completing student/volunteer performance evaluations

Education

• University of Minnesota - Twin Cities
  Doctor of Pharmacy
  

  2009 - 2013

  Major: Pharmacy
• University of Michigan - Ann Arbor
  Bachelor's
  

  1995 - 2000

  Major: Biochemistry, German

• Basic Life Support (BLS) for Healthcare Providers
  American Heart Association
  235412389338
  

  January 2023 - January 2025