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Click here or scroll down to respond to this candidateCandidate's Name
Address: Street Address
Phone: PHONE NUMBER AVAILABLEEmail: EMAIL AVAILABLECitizenship: US CitizenSUMMARY SKILLS1.Clinical/Research Development (R&D):a.Clinical Trial: Study design and evaluation, Protocol writing.b.Regulatory/Drug Development: (IND, NDA, BLA), Drug labeling, new drug safety review, Post marketing drug safety review2.Clinical research experiences:a.Cancerb.Mental Health/ Neuroscience/Psychiatryc.Non communicable disease (Diabetes and cardiovascular diseases)d.Communicable diseases (HIV, TB, STDs)3.Health system activities:a.Epidemiology and Global Healthb.Public Healthc.Health Policy and international Health Regulationd.Minorities, refugees, and disparities researche.Social determinants of healthf.Disaster managements and complex emergenciesg.Monitoring and evaluationh.Decentralization/ health sector reformi.Designing guidelines and training manuals4.General Skills:a.Leadership/managing health projects.b.Problem solvingc.Public speakingd.Teaching and traininge.Communication and negotiationEXPERIENCEFood and Drug Administration (FDA) October 2019- October 2023Department of Health and Human Services10903 New Hampshire Avenue, Silver Spring, MD 20993Senior Staff Fellow/ Clinical Reviewer, (GS-13, 40+ hrs/wk,)Performed scientific reviews and analyses of proposals for studies on oncology indications and new medication for cancer treatment.Performed regulatory assessment on proposed trials and applications for cancer treatment medication. This includesoReviewing the Investigational New Drugs INDs for phase 1, phase 2 and phase 3 of clinical trials studies.oReviewing the New Drug Applications (NDAs), Biologics License Applications (BLAs), Investigational brochures(IB) and drug post marketing evaluation.Participated in drug labeling and developed/ reviewed clinical section of the label(brochure) of the approved new medication for cancer treatment or new indication of the available medication.Reviewed 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 trials 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 the sponsors to develop the befitted protocols and study design:oSelecting the appropriate objectives/endpoints for the study,oDefining the appropriate dose limiting toxicities (DLTs),oIdentifying the right target population and eligibility criteriao Developing study procedures and required safety monitoring measures.Developed the necessary safety evaluation and procedure to avoid any life threating events for the study participantsProvided 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 and conferences and meetings with the Sponsors as a clinical focal point.Amarex Clinical Research, LLC Germantown, MD May 2017- October 201920201 Century Blvd, Germantown, MD 20874Clinical Trial Lead (40+ hrs/wk)Managed all operational aspects of assigned clinical trials, including study start-up, enrollment, study conduct, close-out and the clinical study report (CSR) process.Prepared and reviews 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-Hodgkins Lymphoma, Breast Cancer, GVHD, Solid Tumors, UTI and cutaneous warts.Served as primary contact for site-facing activities and support for clinical questions regarding the study procedures by the clinical staff within all study sites. Conducted and run activities related to data generation and validation, including case report form (CRF) design, clinical data review/query resolution; ensure consistent, quality data review.Served as a contact for study regulatory activities and any technical questions by the studies Sponsors.Directed/participated drafting clinical portions of Regulatory Documents (e.g., pre-IND, IND, IB, DSUR, regulatory responses).Worked with CRO to provide information required for development of trial budget, CRO scope of work and interactions, created and implemented corrective action plan when performance modification was required.Worked with CRO to develop and revised study specific plans and detailed timelines and ensure that transferred obligations and performance expectations are met.Prepared and presented the organization works and achievement in r various conferences and meeting, including; National Alliance for Mental Health, 2018.Monitored progress of site activation and conducted monitoring visits and acted on any deviations from plan and developed/implemented patient recruitment and retention strategies.Ensured data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sites.Served as the main point of contact for clinical operations of the designated projects.University of New England, College of Graduate and Professional Studies (CGPS)716 Stevens Ave.Portland, ME 04103 January 2016 January 2018Adjunct FacultyTaught on-line the following courses for 3 semestersGPH-740 - Global HealthGPH 714 Principles of Public HealthResponsibilities: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 adviser to the students.Memosyn Neurology Institute July 2013 November 2016Lutherville, MDClinical Trial Director and Co-investigatorI worked as Co-investigator in a clinical trial study titled."Cerebrovascular and Cognitive Improvement by Resveratrol and Fruit-flow-II (CCIRF-II)". Clinical trial Identifier; NCT01766180.Main responsibilities included of:Directed the study procedure and patients assessment according to the study protocol.Performed memory assessment, using CANTAB software and other standard tests.Supervised all aspects of the trial and daily based activities of the study including staffs and client management, providing sufficient logistics and monitor and report on the study status and progress towards deliverables goals.Managed and supervised data entry and analysis.Johns Hopkins Bloomberg School of Public Health May 2013 July 2016Division of International Health, Center for Refugee and Disaster Response615 N Wolfe St, Baltimore, MD 21205Post-Doctoral FellowMain responsibilities:Conducted research and policy analysis on health status of Afghan refugees/migrants.Performed systematic review of articles and collecting and analyzing relevant data on health status of Afghan Refugees and migrants, residing in Iran.Researched on child labor status in Afghanistan including review of literature and data collection and analysis.Drafted reports, situation analysis and papers on health status Afghan Refugees and migrants.Tehran University of Medical Sciences January 2011 April 2013Center for Endocrine Diseases ResearchResearcherInvolved in team activities to perform research, review of articles, design and monitoring of non-communicable disease research.Johns Hopkins Bloomberg School of Public Health August 2010 December 2010Division of Mental HealthPost-Doctoral FellowConducted review of litrature on child labor in Afghanistand and amomg the Afghan child refugees/migrants who residing in Iran.United Nations High Commissioner for Refugees (UNHCR) January 2010 July 2010Tehran, IranHealth Officer/ Focal Point, United Nations High Commissioner for Refugees (on Contract per UNHCR payroll)Developed policy and directing the initiative to achieve a better health condition for the Afghan and Iraqi refugees who resided in Iran, according to UNHCR guidelines.Evaluated and monitored of refugees health status to address their needs per UNHCR policiesCollaborated with ministry of health of Iran to ensure the fulfillment of refugees health needs.Initiated and directed the health activities and collaborated with different national and international counterparts and sponsors to fulfill the refugees' health requirements.Designed training program vocational skills to empower women refugees.Negotiated and collaborated with Ministry of Health and Insurance Organization to provide refugees with health insurance.Facilitated undocumented refugees access to essential primary care and other health services.Ministry of Health and Medical Education, March 2009 January 2010Center for Health Education and Health PromotionTehran, IranSupervisory Senior Expert, Health Education and Health PromotionDesigned national health education strategies and supervised training programs for health experts and the general population. I designed and taught many health topics including:Mental health awarenessReproductive healthCommunicable disease prevention (primary care prevention and activities to control and manage HIV/AIDS, Tuberculosis, zoonoses disease, )Non- communicable disease prevention (primary care activities to control, Diabetes, Hypertension, cancers)Monitoring and evaluation of health programImmunization and cold chain managementHealth system decentralization definition and methodsHealth emergency preparedness and responseBasic Epidemiology and clinical trial design and conductDiseases surveillanceRefugees and minorities need.Social determinants of healthMaternity Leave September 2008- March 2009World Health Organization (WHO) January 2007 September 2008Tehran, IranTechnical Officer, (on Contract per WHO payroll)Served as the WHO technical officerAdvised and supervised activities by Ministry of Health regarding health system strengthening,Provided technical support to Ministry of Health to perform health sector reform,Planned and implemented health program, training activities for health experts on health system strengthening subjects.. Appraising WHO collaborating centers in Iran and collaborating with EMRO and MOH and with the different national and international donors/counterparts to ensure proper capacity building in health research.Ministry of Health, January 2006 January 2007Tehran, IranSecretary of Health High CouncilI directed the Health High Councils activities including performing situational analysis, evaluating the national health challenges, drafting and providing high level health information for national decision makers. I have initiated the social determinant of health subjects at the national level, drafted the original national policies and organized the fourth international conference of SDH commissioners in Iran, Jan 2005.Involved on national strategy development for population healthAdvised the high-level health authorities on population health needsDesigned and presented programs for population health improvement to be discussed at policy making meetings by governmentCollaborated with WHO to initiate Social Determinant of Health activities within the countryMinistry of Health, Tehran, Iran October 2004 Jan 2006Senior Expert, Health System StrengtheningI was involved inStrategic planning for health system performance,Monitoring and evaluation of primary health care (PHC),Community health education,Policy advocacy and negotiation with other stake holders to achieve health system goals including insurance organization, national budget allocating authorities, UN agencies, etc.Health sector reform and decentralization initiativesDesigning the monitoring and evaluation protocol for provincial health managers.Establishing a system for family physicians performance evaluation.Co-audited more than 60 facilities and Primary Health Care (PHC)centers annually.Delivered more than 100 presentations and lectures for health professionals and experts on selected health topics.Disaster management and providing health services after Bam Earthquake with more than 50,000 casualties.Developing manuals, guidelines and presentations for health subjects for different levels of audienceWorking on partnership building and community outreach.EDUCATIONDoctor of Medicine, MD September 1991- October 1999Babol University of Medical Sciences,School of Medicine, Babol, IranCERTIFICATES1.NVS, Electroencephalography didactic training, in accordance with the standard set forth by the biofeedback Certification International Alliance (BCIA), March 11th, 2016.2.Health Emergencies in Large Population, John Hopkins University, Bloomberg School of Public Health; July 20103.Gender sensitization workshop, arranged by UNFPA, Iran, 27 May 20104.Capacity Building Workshop on Health System Development by WHO, Alexandria, Egypt, 20085.Health System Decentralization, Nuffield Center for International Health and Development, Leeds University, UK, 20056.Decentralization, Sharing Resources and Responsibilities, by The American universities of Beirut, Tehran, 20047.Communicable Disease Surveillance and complex emergencies and managing Biological Weapons incidents, by WHO, Tehran, 20038.Complex emergency organized by Kurdistan University of Medical Sciences & Medicine de Mond Institute of France, 2003PUBLICATIONMedical Journal.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 hippocampus in elderly with mild cognitive impairment, Journal of Prevention of Alzheimer's Disease, 2016Published Book Chapters:Family Physician Performance Monitoring Candidate's Name , Farshad Farzadfar, Jalal Naeli, (ISBN 964-7657-92-7) 2008Health System Managers' Performance Monitoring Candidate's Name , Farshad Farzadfar, Davood Moghimi, (ISBN 964-7657-98-6) 2007Tools and Techniques for Health Sector Reform (ISBN 964-7657-88-9) 2006Referral System and Family Physician Guidelines. (ISBN964-7657-88-9) 2007 TranslationTranslation.Design and implementation of health information system (by Theo Lippeveld, Rainer Sauerborn, Claude Bodart) Candidate's Name , Farshad Farzadfar, Ghobad Moradi, Farahnaz Farzadfar, ISBN 92 4 1561998. 2006Module on Decentralization of Health Systems: Sharing Resources and Responsibilities Thomas J. Bossert, Ph.D. International Health Systems Group, Harvard School of Public Health. Published in Medicine and development magazine. Candidate's Name , Farshad Farzadfar, 2005REFERENCESDr. Gilbert Burnham,Professor, John Hopkins School of Public Health,Department of International Health,EMAIL AVAILABLETel: PHONE NUMBER AVAILABLEDr. Armaghan Emami, Armaghan Emam PharmD, PhDPharmacology Toxicology ReviewerDivision of Pharmacology/Toxicology for NeuroscienceCenter for Drug Evaluation and Research (CDER)EMAIL AVAILABLETel: PHONE NUMBER AVAILABLE,Tel: PHONE NUMBER AVAILABLEDr. Shide Badri,Medical Director, Senior patient safety physician, AstraZenecaEMAIL AVAILABLETel: PHONE NUMBER AVAILABLE/pre> |
