Overview
Work History
Education
Skills
Publications
Timeline
Generic

Mehrnoosh Hadadi

McLean,USA

Overview

12
12
years of professional experience

Work History

Freelance Regulatory and Clinical Consultant

11.2023 - Current
  • Provided regulatory guidance and clinical expertise for pharmaceutical and biotech companies.
  • Reviewed clinical trial data for compliance and assisted in IND, NDA, and CTD submissions.
  • Advised on trial design and streamlined processes to meet FDA and global standards.
  • Conducted training on regulatory practices and clinical trial management.

Clinical Reviewer/ Analyst

Food and Drug Administration (FDA)
10.2019 - 10.2023
  • Clinical/Safety Reviewer at the FDA for the review and approval of ORGOVYX (relugolix) NDA, an oral gonadotropin-releasing hormone (GnRH) antagonist, indicated for the treatment of prostate cancer.
  • Performed over 120 oncologic (GU cancers and solid tumors) scientific reviews and analyses of proposals for studies in oncology indications and new medication for cancer treatment.
  • Performed regulatory assessment on proposed trials and applications for cancer treatment medication which included the following:
  • Reviewing the Investigational New Drugs (IND) of Phase 1, phase 2, and phase 3 of clinical trial studies.
  • Reviewing the New Drug Applications (NDA), Biologics License Applications (BLA), Investigational Brochures (IB), and drug post-marketing evaluation.
  • Participated in drug labeling and developed/reviewed the clinical section of the label (brochure) of the approved new medication for cancer treatment or new indication of the available medication.
  • Reviewed the safety, efficacy, and reliability of the proposed trials for new investigational cancer medication based on the proposed data by the Sponsor and searched available articles and previous trials to ensure the safety of the study for the participants.
  • Reviewed the potential unfavorable side effects of the study medication on the trial’s participants and evaluated the foreseeable risks of the proposed studies to humans.
  • Reviewed the proposed measures to manage the foreseeable risks of the new medication and developed essential measures to manage the potential risks and side effects.
  • Provided input to Sponsors to develop the befitted protocols and study design by
  • Selecting the appropriate objectives/endpoints for the study
  • Defining the appropriate dose-limiting toxicities (DLTs)
  • Identifying the right target population and eligibility criteria
  • Developing study procedures and required safety monitoring measures.
  • Developed the necessary safety evaluation and procedure to avoid any life-threatening events for the study participants.
  • Provided guidelines and instruction on developing the patient informed consent form (ICF) to inform patients about the study procedure and potential side effects of the treatment and their rights.
  • Reviewed clinical study reports (CSRs), Development Safety Update Reports (DSUR), Annual reports and safety study reports for the ongoing trials, submitted by the sponsors.
  • Participated in training workshops, conferences, and meetings with the Sponsors as a clinical focal point.

Clinical Trial Lead (Manager)

Amarex Clinical Research, LLC
05.2017 - 10.2019
  • Clinical Lead at Amarex, supervise study-related and essential clinical study start-up documents (e.g., Clinical protocols, Informed consent forms, Investigator Brochures, Pharmacy Manual, Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans and charters), Including Colorectal cancer, Non-Hodgkin’s Lymphoma, Breast Cancer, GVHD, Solid Tumors, Schizophrenia and cutaneous warts.
  • Managed all operational aspects of assigned clinical trials, including study start-up, enrollment, study conduct, close-out, and the Clinical Study Report (CSR) process, ensuring compliance with timelines, regulatory standards, and GCP guidelines.
  • Prepared and reviewed essential clinical study start-up documents (e.g., protocols, informed consent forms, investigator brochures, pharmacy manual, monitoring plan, laboratory manual, and patient diary) in alignment with clinical development goals in biotechnology and pharmaceuticals.
  • Acted as primary contact for site-facing activities, providing clinical staff across study sites with support and guidance regarding study procedures, while ensuring data consistency, quality, and compliance.
  • Led and participated in data generation and validation activities, including the design of case report forms (CRFs), conducting clinical data review, and resolving data queries, ensuring consistent, high-quality data throughout the study lifecycle.
  • Directed and authored clinical sections of regulatory documents (e.g., pre-IND, IND, IB, DSUR, regulatory responses), ensuring efficient submission processes and regulatory interactions.
  • Collaborated with the CRO to develop trial budgets, define the scope of work, and manage performance, including creating and implementing corrective action plans as needed to address deviations from the initial plan.
  • Presented organizational achievements at industry conferences and meetings, including the National Alliance for Mental Health (2018), demonstrating leadership in clinical operations and development.
  • Monitored site activation progress and conducted regular monitoring visits to ensure adherence to study plans, addressing plan deviations and implementing patient recruitment and retention strategies.
  • Ensured high data quality by regularly reviewing key metrics, protocol deviations, eligibility violations, dosing errors, and addressing non-compliance issues, upholding rigorous standards for clinical trials.
  • Served as the main point of contact for clinical projects, overseeing the day-to-day management of trials, ensuring operational efficiency, and supporting the successful execution of the study in alignment with clinical and regulatory objectives.

Adjunct Faculty

University of New England, CGPS, Portland ME
01.2016 - 01.2019
  • Taught; GPH-740 - Global Health and GPH 714 – Principles of Public Health
  • Prepared and delivered lectures to undergraduate or graduate students on epidemiologic studies, clinical trial design and monitoring, global health.
  • Evaluated and graded students' class work, assignments, papers, and final exam.
  • Initiated, facilitated, and moderated classroom discussions to engage students’ participation.
  • Acted as an advisor to the students.

Clinical Trial Director and Co-Investigator

Memosyn Neurology Institute
07.2013 - 11.2016
  • Worked as Co-investigator in a clinical trial study entitled "Cerebrovascular and Cognitive Improvement by Resveratrol and Fruit-flow-II (CCIRF-II)" clinical trial Identifier; NCT01766180 in which responsibilities included:
  • Directing study procedure and patient assessment according to the study protocol.
  • Performed memory assessment, using CANTAB software and other standard tests.
  • Supervised all aspects of the trial and daily activities of the study including staff and client management, providing sufficient logistics and monitoring and reporting on the study status and progress towards deliverables goals.
  • Managed and supervised data entry and analysis.

Post-Doctoral Fellow

Johns Hopkins Bloomberg School of Public Health
05.2013 - 07.2016
  • Conducted research and policy analysis on the health status of Afghan refugees/migrants.
  • Performed systematic review of articles and collected and analyzed relevant data on health status of Afghan Refugees and migrants, residing in Iran.
  • Researched child labor status in Afghanistan including a review of literature and data collection and analysis.
  • Drafted reports, situation analysis, and papers on the health status of Afghan Refugees and migrants.

Education

Master of Public Health - Public Health

Tehran University of Medical Sciences
02.2006

Medical Doctor (MD) - Doctor of Medicine

Babol University of Medical Sciences
10.1999

Skills

  • Clinical/Research Development (R&D):
  • Directing and coordinating the implementation of a study (s)
  • Study design and evaluation
  • Protocol writing
  • Regulatory/Drug Development: (IND, NDA, BLA)
  • Real world data usage
  • Drug labeling
  • New drug safety review
  • Post-marketing drug safety review
  • Drug Development and Safety
  • Medical monitoring
  • Pharmacovigilance
  • Drug safety evaluation
  • Averse event review and report
  • General Skills:
  • Leadership/managing health projects
  • Problem-solving
  • Public speaking
  • Teaching and training
  • Communication and negotiation
  • Monitoring and evaluation

Publications

  • Survival outcomes in older men with non-metastatic castration-resistant prostate cancer treated with androgen receptor inhibitors: A US Food and Drug Administration pooled analysis of patient-level data from three randomized trials, Lancet Oncology, July 2021.
  • A Personalized 12-week “Brain Fitness Program” for improving cognitive function and increasing the volume of the hippocampus in elderly with mild cognitive impairment, Journal of Prevention of Alzheimer's Disease, 2016

Timeline

Freelance Regulatory and Clinical Consultant

11.2023 - Current

Clinical Reviewer/ Analyst

Food and Drug Administration (FDA)
10.2019 - 10.2023

Clinical Trial Lead (Manager)

Amarex Clinical Research, LLC
05.2017 - 10.2019

Adjunct Faculty

University of New England, CGPS, Portland ME
01.2016 - 01.2019

Clinical Trial Director and Co-Investigator

Memosyn Neurology Institute
07.2013 - 11.2016

Post-Doctoral Fellow

Johns Hopkins Bloomberg School of Public Health
05.2013 - 07.2016

Medical Doctor (MD) - Doctor of Medicine

Babol University of Medical Sciences

Master of Public Health - Public Health

Tehran University of Medical Sciences

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Mehrnoosh Hadadi