Jamil Ahmed

**** ** ** ******, ***#***, Miami, FL 33125

Phone: 305-***-****, email: accfzo@r.postjobfree.com

OBJECTIVE:

Seeking a position in the biopharmaceutical industry that will allow me to challenge my educational

background, skills and knowledge, and contribute in the success of a biopharmaceutical research and drug

development team

PROFESSIONAL HIGHLIGHTS:

• Total 10 years of experience in health care, performing Clinical Research

• Managed phase I thru III trials

• Extensive knowledge of drug, human pathophysiology, and diseases

• Experience in Investigator Initiated Trials, Sponsored Trials, and Translational Research.

• Extensive knowledge of clinical research, drug development process, regulatory requirements,

good clinical practices, human pathophysiology & diseases

• Demonstrate project management, coordination, organizational skills

• In-depth ability to think analytically, process scientific and medical data

• Possess remarkable ability to work and make independent decisions, understand complex medical

information, and able to take the initiative to lead projects and assignments

• Sound ability to coordinate and motivate independently

• Experience in Oncology (Myelodysplastic Syndrome, Multiple Myeloma, Small/Non-Small Cell

Lung Cancer, Breast, Lymphoma, Leukemia, Sarcoma), Infectious Diseases, Cardiovascular

Diseases, and Respiratory Diseases

• Creation of standard Operating Procedures (SOP’s) used to standardize research processes

• Knowledge of Federal Regulatory Requirements, IRB Reporting, industry standards, ICH and

NIH guidelines, protocol submissions, and SAE’s submissions

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Jamil Ahmed

WORK EXPERIENCE:

University of Miami – Miller School of Medicine Sep 2012 - Present

Sylvester Comprehensive Cancer Center

Clinical Team Leader/Senior Clinical Research Coordinator

• Work with SDG Investigators to manage clinical trial portfolio and track new patient volumes

• Associated with the evaluation, initiation, management, and close-out of clinical trials

• Identify barriers to enrollment and review them in follow-up meetings with site staff

• Organize site initiation visits and training for newly opening studies

• Actively screen and consent patients for clinical studies

• Maintain deviation, AE, and SAE logs and communicate findings according to IRB and Sponsor

guidelines

• Implement Lean methods to streamline research activities and reduce waste and deviations

• Oversee regulatory documents to ensure that FDA requirements are met

• Mentor new research staff

• Member Protocol Review Committee

• Perform quality monitoring and auditing of on-going clinical studies to ensure compliance with

protocols, federal regulations, and GCP/ICH guidelines

• Involved in Study billing & budget

H Lee Moffitt Cancer Center and Research Institute, Tampa, Florida

National Cancer Institute Comprehensive Cancer Center

Clinical Research Coordinator II–Immunotherapy/Oncologic Sciences (Vaccine) Program

2008 – 2011

• Screen, enroll, and follow study subjects, ensuring protocol compliance and close monitoring

while the subjects are on study

• In-depth knowledge of protocol requirements and good clinical practices as set forth by Federal

regulations

• As the primary resource for the protocols, coordinate and provide direct patient care, perform

ongoing assessments, deliver patient education, and document in accordance with standards and

regulatory guidelines

• Coordinates internal and external clinical trial activities of all team members involved in the

design and conduct of clinical trials

• Act as liaison between the investigators, primary care providers, regulatory staff and the sponsor

• Responsible for data and source documentation, assessing potential drug-related toxicities,

adverse event/SAE reporting in compliance with FDA regulation

• Experience writing safety narratives, safety related analysis, working with data endpoints, query

resolution and medical documents

• Using Cerner Application System for electronic patient notes and Oncore for research database.

• Monitor, review, and analyze data reports for content and assimilate comments to internal team

and vendor

• Prepares reports/summaries of various components of trial activity

• Assists with writing, editing, amending, reviewing clinical trial documents, including protocols,

sample ICFs

• Mentor new research staff (Research Coordinator, Data Managers), also teaching human subject

research methods to rotating Medical Residents/Fellows from Shenzen University, China

• Worked in protocols involving Sarcoma, Myelodysplastic Syndrome, Multiple Myeloma,

Small/Non-Small Cell Lung Cancer, Breast, Mantle Cell Lymphoma, Chronic Lymphocytic

Leukemia

East Tennessee State University - James H. Quillen College of Medicine

Clinical Research Coordinator, Department of Internal Medicine.

March 2007 – August 2008

• Screening, recruiting, enrolling, and evaluating potential patients for protocol eligibility.

Presenting trial concepts and details to the patients, participate in the informed consent process,

and enroll patients according to ICH/GCP/FDA guidelines

• Coordinate patient care in compliance with protocol requirements. Interact with Principal

Investigator as needed to assure patient receives appropriate medical evaluation and care when

needed, alerts Principal Investigator of serious adverse events

• Review study patients for changes in conditions, adverse events, concomitant medication use,

protocol compliance, response to study drug and thoroughly documenting all findings. Serves as a

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Jamil Ahmed

liaison between physicians, nurses, patients, and the sponsors

• Responsible for accurate and timely data collection, order laboratory investigation,

documentation and reporting. Schedule and participate in monitoring and auditing activities.

• use of electronic medical record (Cerner Application Systems)

• Assure that protocol compliance is maintained. Communicates with physician regarding study

requirements, need for dose modification, and adverse event/SAE reporting

• Follow-up of study subjects, completion of source documents and case report forms, reporting of

serious adverse events, and dispensing/accountability of investigational product

• Preparing IRB documents (Protocol, Informed Consent, Narrative, 1572, Contract, Modification

Forms, SAE, AE Reporting, IND Safety Reports etc) and submission of project materials to the

Office of Human Subjects Protection and Research Review Committee

• Maintains subject screening logs and performs quality assurance evaluations as required

• Preparing for and participating in Sponsor audits

• Worked in protocols involving Infectious Diseases and Allergy/Immunology

National Institute of Trauma and Orthopedic Rehabilitation, Dhaka, Bangladesh

Primary Care Medical Officer 2003 – 2006

Management of inpatient and outpatient patients, attending emergency cases, and performing and

assisting various surgeries

University of Arkansas for Medical Sciences, Department of Emergency Medicine, Little Rock,

Arkansas. 2000 – 2002

Clinical Research Coordinator

• MARC study (Multi-Center Airway Research Collaboration); recruiting, enrolling, and

monitoring study patients, according to ICH/GCP/FDA guidelines. Collecting clinical data,

completing case report forms and interacting with pharmaceutical sponsors.

• Recruitment and evaluation of potential study patients with regard to study including patient

education, procedural instruction, and follow-up. Served as a liaison between patient and

physician.

• Collecting data for research projects and maintaining information in a computerized database.

• Providing a resource for patients and their families, from informational items to comfort measures

College of Physicians and Surgeons of Columbia University, Department of Medicine

Clinical Research Assistant 1996 –

1999

Actively worked in clinical research studies such as:

• Silent Myocardial Ischemia.

• Gender and Quality of Life in African-Americans with Congestive Heart Failure.

Responsibilities:

• Responsible for screening, recruiting, enrolling, and evaluating potential patients for protocol

eligibility.

• Educates patients in significant aspects of the study. Ensured that the studies are conducted in

accordance with the guidelines of the FDA and other regulatory agencies.

• Working with Principal Investigator to develop and implement patient recruitment strategies.

• Organized and maintained study database.

• Participated in the development of new research protocols including design and data collection

system.

• Assist Principal Investigator with preparation of articles and for presentation

Brooklyn VA Medical Center, Brooklyn, New York. 1994 -

1995

Clinical Externship

Department of Medicine, Division of Pulmonary Medicine under Dr. J.P. Finch .

Dhaka Medical College Hospital, Dhaka, Bangladesh. 1993 –

1994

Primary Care Medical Officer

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Jamil Ahmed

Salimullah Medical College and Mitford Hospital, Dhaka, Bangladesh. 1991 - 1992

One year of rotating Clinical Internship (Family Medicine)

EDUCATION:

HSC, Higher Secondary Certificate, Notredame College, Dhaka, Bangladesh.

MBBS, Bachelor of Medicine and Surgery, University of Dhaka, Bangladesh.

USMLE, United States Medical Licensing Examination (ECFMG Certification)

Masters Level Course – Health Information Systems and Organizational Management

(Grand Canyon University)

CERTIFICATIONS:

• ECFMG Certification (Educational Commission for Foreign Medical Graduates)

• Internship Training Certificate (ranked excellent) 1991-1992

• Permanent Physician Registration (Bangladesh Medical and Dental Council) 1992

• Certified blood Bourne Pathogens Training consistent with OSHA Blood Bourne Pathogen

Standard 29 CFR1910.1030 2011

• University of Miami - CITI Certification for Research on Human Subjects Valid thru 2014

• National Cancer Institute - Clinical Research Training Certificate 2007

• Certificate of Continuing Medical Education - Harvard Medical School-Rheumatoid Arthritis,

Initiative for Improved Diagnosis and Outcomes 2007

• Certificate of Continuing Medical Education - AIDS 2006: XVI International AIDS Conference-

Global HIV Epidemiology, Sexual Transmission of HIV, and Prevention Strategies. 2007

• Certification: Inform GTM 5.5 IOL-ORACLE, Rave 5.6 Medidata

ABSTRACTS/PUBLICATIONS:

• PUBLICATION: International Journal of Radiation Oncology: Combination of External Beam

Radiotherapy (EBRT) with Intratumoral Injection of Dendritic Cells as Neo-Adjuvant Treatment of High-

Risk Soft Tissue Sarcoma Patients. Steven Finkelstein MD, Cristina Iclozan PhD, Marilyn Bui MD,

Mathew J. Cotter PhD, Rupal Ramakrishnan PhD, Jamil Ahmed MBBS

• ABSTRACT: Detailed Immunological Monitoring of Myeloid Derived Suppressor Cells and

Regulatory T Cells in a Phase I/II Trial of High-Risk Soft Tissue Sarcoma Patients undergoing External

Beam Radiation and Intramural Dendritic Cell Vaccination. Cristina Iclozan, Jamil Ahmed, Marilyn M.

Bui, Mathew J Cotter, Rupal Ramakrishnan, David Cheong, Randy Heysek, Vernon K. Sondak, Douglas

Letson, Scott J. Antonia, Dmitry Gabilovich, and Steven E. Finkelstein.

• ABSTRACT: ‘Gender and Quality of Life of African-Americans with Congestive Heart Failure’

American Cardiology Council 46th Annual Scientific Session. College of Physicians and Surgeons of

Columbia University University, New York

• ABSTRACT: WHO WATCHES THE WATCHMEN: Novel Image Guided Visualization of

Experimental Cellular Based Immunotherapy Against Soft Tissue Sarcoma Steven Eric Finkelstein,

Dmitry I. Gabrilovich, Irfan M. Ahmed, Jamil Ahmed, Claudia Berman, Marilyn M Bui, Alec Chau,

David Cheong, Edward Eikman, Ricardo J. Gonzalez, Randy V. Heysek, David A. Johnson, Vernon K.

Sondak, Rosemary R. Szekely, Jonathan S. Zager, G. Douglas Letson, Scott J. Antonia

• ABSTRACT: Pospective Phase I/II Trial of Intratumoral Dendritic Cell Vaccine Immunotherapy

(DC) Combined with External Beam Radiation (EBRT) for Neo-Adjuvant Treatment of Soft Tissue

Sarcoma. Steven Eric Finkelstein, Dmitry I. Gabrilovich, Jamil Ahmed, Marilyn M. Bui, Matthew J.

Cotter, David Cheong, Ricardo J. Gonzalez, Randy V. Heysek, Brianna C. Lenox, Vernon K. Sondak,

Rosemary R. Szekely, Jonathan S. Zager, G. Douglas Letson, Scott J. Antonia.

• ABSTRACT: A phase I Pilot Study of Bystander Vaccine and Lenalidomide Combination, in

Patients with High Risk Myelodysplastic Syndromes. Padron Eric, Rami Komrokji, Jeffrey Lancet,

Sophie Dessureault, Scott J. Antonia, Jamil Ahmed, Shiddhi Patel, Eduardo Sotomayor, P.K. Burnette,

Javier Pinilla.

STUDIES INVOLVED:

1. DORIINI2002: Phase 2, Open-label, Non Comparative Study of Doripenem in the Treatment of

Nosocomial and Ventilator-Associated Pneumonia in Hospitals where Pseudomas Aeruginosa

may be a Prevalent Pathogen.

PI: Felix Sarubbi, MD.

2. ACCENTIA: Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-

Group Study of Intranasal AmB Suspension in Patients with Refractory Postsurgical Chronic

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Jamil Ahmed

Sinusitis (CS).

PI:Krishnaswamy Guha, MD.

3. ATTAIN: A Phase 3, Randomized, Double-Blind, Parallel-Group, Multinational Trial of

Intravenous Telavancin versus Vancomycin for the Treatment of Hospital Acquired Pneumonia

with a Focus on Patients with Infections due to Methicillin Resistant Staphylococcus Aureus.

PI:Felix Sarubbi, MD.

4. CDAD: A Multi-National, Multi-Center, Double-Blind, Randomized, Parallel Group Study to

Compare the Safety and Efficacy of 200mg of PAR-101 (Difimicin) taken q12h with 125mg of

Vancomycin taken q6h for 10 Days in Subjects with Clostridium Difficile-Associated Diarrhea.

PI:Jonathan Moorman, MD., PhD.

5. Combination of External Beam Radiation with Intratumoral Injection of Dendritic Cells as Neo-

Adjuvant Treatment of High-Risk Soft Tissue Sarcoma Patients.

PI:Scott Antonia, MD., PhD.

6. Combination Immunotherapy for Non Small Cell Lung Cancer(Adenocarcinoma) A Phase II Trial

Using a GM-CSF-Producing and CD40L-Expressing Bystander Cell Line (GM.CD40L) in the

Formulation of Allogeneic Tumor Cell-Based Vaccines in Combination with ATRA, and

Cyclophosphamide for Patients with Stage IV Adenocarcinoma of the Lung.

PI: Alberto Chiappori, MD.

7. Augmenting Vaccine Efficacy with Lenalidomide – A Phase I Pilot Study of Immunotherapy

Combined Therapy with Lenalidomide Plus “Bystander” Vaccine (GM.CD40L Vaccine) in

Participants with High Risk Myelodysplastic Syndrome (MDS).

PI: Javier Pinilla, MD., PhD.

8. Combination Immunotherapy for Small Cell Lung Cancer - A Randomized Phase II Trial Using

Dendritic Cells Transduced with an Adenoviral Vector Containing the p53 Gene to Immunize

Patients with Extensive Stage Small Cell Lung Cancer in Combination with Chemotherapy With

or Without All Trans Retinoic Acid.

PI: Alberto Chiappori, MD.

9. A Phase II Trial using a Universal GM-CSF Producing and CD40L-Expressing Bystander Cell

Line (GM.CD40L) in the Formulation of Autologous Tumour Cell- Based Vaccines for Patients

with Mantle Cell Lymphoma.

PI: Sophie Dessureault, MD., PhD., MRCP.

10. A Phase Ib Study of Repeated Doses of Autologous Ad-ISF35-transduced CLL B Cells in

Combination with Fludarabine, Cyclophosphamide and Rituximab (FCR) in Subjects with

Refractory and/or del(17p) Chronic Lymphocytic Leukemia (CLL)

PI: Javier Pinilla, MD, PhD.

11. Phase I Parallel Protocol of MK-0646 (Dalotuzumab) + MK-2206 and MK-0646

(Dalotuzumab) + MK-0752 Doublets (MKMK) in Patients with Advanced Cancer

PI:Jhanelle Gray, MD.

12. A phase I Dose-Escalation Study of Safety, Pharmacokinetics, Pharmacodynamics of XL228

Administered Intravenously to Subjects with Chronic Myeloid Leukemia or Philadelphia

Chromosome Positive Acute Lymphocytic Leukemia

PI: Javier Pinilla, MD, PhD.

13. A Randomized Phase II Trial Using a GM-CSF-Producing and CD40L-Expressing Bystander Cell

Line (GM.CD40L) Vaccine in Combination with CCL21 for Patients with Stage IV

Adenocarcinoma of the Lung.

PI: Jhanelle Gray, MD.

14. A Study of the Safety and Efficacy of the Combination of Gemcitabine and Docetaxel with

MORAb-004 in Metastatic Soft Tissue Sarcoma, MORAb-004-203-STS . Sponsor: Morphotek

PI: Jonathan C. Trent, M.D., Ph.D.

15. Randomized Controlled Study of YONDELIS® (Trabectedin) or Dacarbazine for the Treatment

of Advanced Liposarcoma or Leiomyosarcoma, ET743-SAR-3007. Janssen Research and

Development, LLC .

PI: Fernando Gustavo-Castro, MD.

16. Multicenter Phase II Study to establish Gene Expression Models Predicting Survival of Diffuse

Large B-CELL Lymphoma Patients Treated with R-CHOP.

PI: Izidore Lossos, M.D.

17. A Double-Blind, Randomized, Placebo-Controlled Phase III Study to Assess the Efficacy of

RecMAGE-A3 + AS15 ASCI as Adjuvant Therapy in Patients with MAGE-A3 Positive Resected

Stage III Melanoma, GSK-DERMA.

PI: Lynn Feun, MD.

18. A Phase III Randomized, Double-Blind, Placebo-Controlled Study of Sorafenib as Adjuvent

Treatment for Hepatocellular Carcinoma after Surgical Resection or Local Ablation, BAYER

PI: Lynn Feun, MD.

19. ECOG E1609: A Phase III Randomized Study of Adjuvant Ipilimumab Anti-CTLA4 Therapy

versus High-Dose Interferon a-2b for Resected High-Risk Melanoma.

PI: Mecker Moller, MD.

AWARDS:

• National Merit Scholarship throughout medical school (1984-1990).

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• Certificate of Appreciation for organizing the first symposium on AIDS awareness in Bangladesh.

• Served as Vice President, Secretary, Editor, and Senior Member of SSMC Rotary Club

• Nominated for Employee of the Year 2009 at Moffitt Cancer Center

REFERENCES:

Available upon request

www.linkedin.com/pub/jamil-ahmed-md/20/347/919/

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