Clinical Scientist

CAREER SUMMARY

I have an MD degree with more than 8 years of clinical and basic science research,

clinical trials oversight/execution, medical monitoring/pharmacovigilance, clinical data curation/analysis, medical/scientific writing, and patient engagement/recruitment experience in Oncology, Neurodegenerative disorders, and Rare Diseases at leading academic institution, top pharmaceutical companies, a thriving CRO and patient advocacy group.

Here is a summary of my work experience:

Therapeutic area Indication Role How long? Employer Oncology Hepatocellular

Carcinoma (HCC)

As Lead Clinical Scientist,I was responsible for clinical oversight, safety and medical monitoring of Keynote Clinical Trials (Phase IIB & III) of Keytruda for advanced Hepatocellular Carcinoma (HCC), authoring

protocol/protocol amendments, interacting with

KOL/PI, resolve queries regarding AE/SAE, study

protocol & subject eligibility. Provide support in patient recruitment, study conduct, and management of CRO, etc. Provide protocol training to SC/CRA and mentor CS/CTA. Study closeout, data analyses, and authoring of CSR for Phase IIB study.

1 year

(Oct 2016

to Nov

2017)

Merck

(ExecuPharm)

Oncology, CNS,

Rheumatology, &

Rare Diseases

Non- Hodgkin's

Lymphoma (NHL),

Alzheimer's

Disease & Lewy

Body Dementia,

Rheumatoid

Arthritis, and

Familial Amyloid

Polyneuropathy

(FAP)

As Director of Patient and Site Services,I worked with multiple clients (Bayer - Chronos Trials for NHL, Axovant and Lundbeck -Alzheimer's Disease & Lewy Body

Dementia studies, Regeneron - OA Study)internationally to achieve successful enrollment of subjects for Phase I-III clinical trials across multiple therapeutic areas. Primarily responsible for site initiation/training, patient screening, responding to PI/Site queries regarding protocol or subject eligibility, study protocol training to SC/CRA, etc. Lead a cross-functional team of nurses and site liaisons (7 Direct Reports), worked directly with Project Management, Marketing, Business

Development, IT and Database Management to achieve study deliverables.

1.2 years

(Aug 2015

to Oct

2016)

Bioclinica (CRO)

1

Rare Diseases Primary Nephrotic

Syndrome (FSGS,

Membranous

Nephropathy, etc.)

As Manager and Associate Director of Clinical Research at the patient advocacy group, I primarily worked with the NIH Office of Rare Diseases Research (ORDR),

Patient-Centered Outcomes Research Institute (PCORI) and the University of Michigan, Ann Arbor to establish an IRB Approved Patient-Powered Research Network

(PPRN) - a clinical database registry to support basic science research and clinical trials. Supported the foundation to adjudicate grant applications, oversaw patient education/engagement, managed patient

advocates and interns (5 Direct Reports)

2 years

approx

(Sep 2012

to Jul

2014)

NephCure

Foundation

(Patient

Advocacy

Group)

Oncology Multiple solid

malignancies

As Clinical Research Scientist,I supported pre-clinical and early phase clinical trials by providing clinical oversight, authoring protocols, CSR, manuscripts,

abstracts etc. I was responsible for validation of drug targets, analyses of clinical & biomarker data, and established a customized genotyping platform to

simultaneously review and analyze somatic mutations and copy number variations (CNV) across multiple

tumor types.

2 years

approx

(Feb 2009

to Jun

2011)

GlaxoSmith

Kline

(ZeroChaos)

Oncology Head & Neck, Lung

and Esophageal

Cancers

As Postdoctoral Research Fellow, I worked in Hem-Onc laboratory to generate and study genome-wide copy

number and gene expression data of head & neck,

esophageal and lung cancers using high-resolution SNP arrays. I worked with the PI to conduct a Phase III trial to evaluate the safety and efficacy of Sorafenib in refractory Thyroid Cancers (Bayer Study). I also worked as a manager of Head and Neck Tumor Bank.

2.2 years

(Oct 2006

to Dec

2008)

University of

Pennsylvania

Real Estate

Business

N/A As Managing Director, I successfully directed operations of family real estate business including oversight and management of ongoing projects, administrative staff and their responsibilities. I also undertook market, financial and qualitative analyses, and successfully negotiated deal terms with external vendors, local government, etc.

3 years

approx

(Jan 2018

to May

2019),

(Aug 2014

to Aug

2015) &

(Jun 2011

to Aug

2012)

Aziz Builders &

Associates

2

M. Usman Aziz, M.D.

Phone: 484-***-**** Email: *.*****.****@*******.*** EDUCATION

Masters (MS) in Clinical and Translational Science, (starts in Fall 2019) Doctor of Medicine (MD), December 2005

The Aga Khan University Medical College, Pakistan

High School Diploma (HSSC), Pre-Medical Studies, July 1999 Cadet College Hasan Abdal, Pakistan

HIPAA and Human Subject Research Certifications

SKILLS & EXPERTISE

Strong healthcare and medical knowledge of clinical oncology and cancer genomics, extensive basic science and clinical research, clinical trial oversight, and patient recruitment & retention experience

Expertise in protocol, scientific and grant writing; thorough understanding of drug development and pharmaceutical industry, including ICH, GCP, IRB and HIPAA guidelines

Extensive medical monitoring, pharmacovigilance, and clinical data curation and analysis experience

Strong leadership and team management, program development and project management skills

Experience in strategic planning, budgeting, and policy development

Excellent oral & written communication, presentation, and interpersonal skills PROFESSIONAL EXPERIENCE

Clinical Scientist, Merck Oncology, Global Clinical Development, Upper Gwynedd, PA October 2016 – November 2017

Provide clinical and scientific expertise in the planning, execution, medical monitoring, reporting, and subject enrollment for Phase II-III global keynote clinical trials of Keytruda (Immuno-Oncology) in Hepatocellular Carcinoma (HCC) (http://keynoteclinicaltrials.com/trials/liver-cancer)

Review and author clinical documents including study protocols and amendments, clinical study reports, responses to regulatory authorities, scientific manuscripts and abstracts etc.

Review, analyze, and report the safety, efficacy and clinical trial data using JReview and InForm, verbal and written communication of complex clinical/scientific concepts and results

Create and foster professional relationships with Key Opinion Leaders (KOL) and Principal Investigators

(PI), address requests for medical information and resolve queries regarding study protocol, AEs/SAEs, study treatment discontinuation and subjects eligibility etc.

Contribute to the organization and preparation of Investigator Meetings (IM), Database Monitoring Committee (DMC) meetings etc.

Work closely and interact regularly with colleagues from clinical operations, data management, statistics, medical and regulatory affairs, and serve as a core member of cross-functional CTT

Provide protocol training to site staff and CRA, mentor Clinical Scientists and Clinical Trial Associates

Manage and support day-to-day activities of external vendors including CRO

Review and maintain comprehensive and up-to-date scientific information of disease state, clinical and investigational product data, and competitor landscape in Oncology M. Usman Aziz, M.D. Page 2

Director, Patient and Site Services, Global Clinical Research, Bioclinica, Audubon, PA August 2015 – October 2016

Provide leadership and oversight in managing patient pre-screening, recruitment and retention for multiple Phase II-IV global clinical trials in oncology, neurodegenerative disorders, rheumatology, and rare diseases (http://www.bioclinica.com/what-we-do/patient-recruitment-retention)

Provide support in study site activation, assist in training CRA and site medical staff in subject enrollment as per study protocols

Provide expertise in the development of pre-screener questionnaires based on the study protocols and CRF, and systematically optimize pre-screeners in order to address potential recruitment challenges

Review and interpret patients’ medical records, effectively manage patient pre-screening and referral process, facilitate patient-study site matches, and ensure study sites follow through on all subject referrals in a timely manner

Cultivate professional relationships with Principal Investigators (PI), Study Coordinators (SC) and CRA, and resolve their queries regarding subject referral and eligibility as per study protocols

Supervise and manage clinical trial enrollment activities across cross-functional teams, multiple trials and vendors according to the contract, budget and scope of work

Serve as point of contact for the study sponsors to ensure clinical trial screening and enrollment are progressing according to the study protocol, IRB guidelines and sponsor’s needs/expectations

Work closely and interact regularly with project managers, IT, BD, and marketing departments to ensure successful completion of clinical trials enrollment where success includes: on-time, on-budget, according to SOPs, ICH-GCP and local regulations in accordance with high quality standards and contract specifications

Manage department budget, develop and periodically review department SOPs, and author all patient enrollment and clinical study-related documents for IRB approval

Interview, hire, train, and manage overall performance of nurse navigators and senior site liaisons based in the US and Europe (7 direct-reports)

Associate Director, Clinical Research, The NephCure Foundation, Berwyn, PA August 2013 – July 2014

Plan, develop, and manage the NephCure Kidney Network (NKN) Patient Recruitment Program in collaboration with the NIH Office of Rare Diseases Research (ORDR), Patient Centered Outcomes Research Institute (PCORI), and the University of Michigan, Ann Arbor

(https://www.nephcurekidneynetwork.org/default.aspx)

Author, review and successful approval of grant award by PCORI to establish Patient-Powered Research Network (PPRN) for primary nephrotic syndrome patients

Provide support to the scientific advisory board for grants adjudication

Author and review NKN Program protocol, ICF, brochures and patient recruitment materials

Design and oversee outreach programs and direct patient enrollment for clinical trials conducted by various pharmaceutical and biotechnology companies

Author and establish NKN Recruitment Program governance model, policies, best practices, and procedures

Work directly with KOL, physicians, scientists, and patients to develop Patient-reported Outcomes for rare kidney diseases

Evaluate and measure the performance of the NKN Registry Program, analyze clinical data, summarize and present at various scientific conferences and meetings M. Usman Aziz, M.D. Page 3

Develop and monitor NKN Registry Program budget, liaise with funding institutions to complete all required fiscal standards

Moderate NKN Registry Program Steering Committee, serve as a key member of PCORI Patient Engagement and Data Privacy Task Forces

Interview, hire, train, and mentor patient advocates, patient coordinators, and interns (5 direct-reports)

Manager, Clinical Research, The NephCure Foundation, Berwyn, PA September 2012 – July 2013

Plan, develop, and implement all strategic and operational aspects of the NKN Registry Program

Author, review, and successful approval of grant award by NIH National Center for Advancing Translational Sciences (NCATS) to establish the NKN Program

(https://www.nephcurekidneynetwork.org/default.aspx)

Develop educational and training materials for patients, organize and conduct conferences and seminars for physicians, nurses, and other healthcare professionals

Conduct web-based and live patient outreach sessions to enhance enrollment for the NKN Program

Constitute the NKN Program Advisory Committee, consisting of leading nephrologists, scientists, and pharmaceutical industry representatives; moderate committee meetings and manage communication between key stakeholders

Collaborate with Program Advisory Committee and Patient Crossroads (NKN Registry Program Vendor) to develop governance protocols, maintain high functional performance, and implement ongoing system enhancements

Clinical Research Scientist, GlaxoSmithKline Oncology R&D, Collegeville, PA February 2009 – June 2011

Assist in planning and execution of pre-clinical studies and early-phase clinical trials, validate drug targets, analyze and report clinical, biomarker, and experimental data

Author, review and edit clinical documents including study protocols and clinical study reports, compose and evaluate CRF, and periodically update investigator brochure

Author and review scientific submissions such as conference abstracts, posters, peer-reviewed manuscripts, internal and external presentations

Review and interpret laboratory and clinical data of different cancer types; review technology-based literature to identify novel therapeutic targets, and evaluate new technologies applicable to cancer metabolism drug discovery and development

Provide leadership in the development of a customized genotyping platform after high-throughput sequencing validation to simultaneously review and analyze somatic mutations and copy number variations across multiple tumor types

Post-doctoral Research Fellow, Department of Oncology, University of Pennsylvania School of Medicine, Philadelphia, PA

October 2006– December 2008

Generate and analyze genome-wide copy number variations and gene expression data of head & neck, esophageal, and lung cancers at high-resolution human SNP arrays

Author, review and successful approval of grant award by the University of Pennsylvania's NIH Center for Molecular Studies in Digestive and Liver Diseases M. Usman Aziz, M.D. Page 4

Author and review conference abstracts, posters, and peer-reviewed scientific manuscripts

Enroll patients in Phase III clinical trial to evaluate the safety and efficacy of Sorafenib in refractory Thyroid Cancers, examine and evaluate enrolled subjects during study visits

Collect, curate and analyze clinical data, and conduct extensive review of patients’ medical records to establish correlation between cancer mutations, genomic profiles, and clinical outcomes

Develop and manage the head & neck tumor bank, interact regularly with key investigators, pathologists, and various national and international research centers to procure and distribute tissue specimens as per institutional guidelines

CLINICAL TRAINING

Clinical Intern, Hearts International Hospital, Oncology Division, Pakistan Jan 2006 – Sept 2006 and March 2012 – May 2012

Gain extensive hands-on clinical experience in Oncology Ambulatory Care Center

Provide medical care by interviewing, examining and treating patients

Participate in final medical judgment in all issues of healthcare, prepare academic presentations, and discuss important clinical cases in monthly review meetings

Design patient outreach program and direct patient enrollment for local cancer registry to support basic science research and multiple clinical studies

Author and develop educational and training materials for patients, families, and caregivers GRANT AWARDS

1. CO-PRINCIPAL INVESTIGATOR: PATIENT POWERED RESEARCH NETWORK FOR PATIENTS WITH PRIMARY NEPHROTIC SYNDROME

TOTAL AWARD: $640,600

Awarded by: Patient Centered Outcomes Research Institute (PCORI) 2. PRINCIPAL INVESTIGATOR: NEPHCURE KIDNEY NETWORK PATIENT REGISTRY PROGRAM TOTAL AWARD: $50,000

Awarded by: NIH National Center for Advancing Translational Sciences (NCATS) 3. CO-PRINCIPAL INVESTIGATOR: GASTROINTESTINAL CANCER PILOT PROJECT GRANT TOTAL AWARD: $100,000

Awarded by: Abramson Cancer Center and the University of Pennsylvania's NIH Center for Molecular Studies in Digestive and Liver Diseases

PUBLICATIONS

1) J Dauber, C Fix, M Hailperin, MU Aziz,A Swan, B Marshall, L Mariani, EL Cope. Establishment of a Patient Registry to Engage Patients in Research of Nephrotic Syndrome. Presented at National Conference on Engaging Patients, Families, and Communities in all Phases of Translational Research to Improve Health hosted by Duke University’s Translational Medicine Institute, MARCH 2015 2) EL Cope, MU Aziz, L Mariani, M Hailperin, J Dauber, A Swan, B Robinson. NephCure Kidney Network: A new PCORnet vehicle to advance research in primary Nephrotic Syndrome. Presented at American Society of Nephrology (ASN); NOV 2014

3) MU Aziz,EL Cope, L Mariani, M Hailperin, J Dauber, A Swan, C Fix, B Marshall, B Robinson. Using Patient Reported Data to accelerate primary Nephrotic Syndrome Clinical Research. Presented at Community Engagement Conference; JUN 2014

M. Usman Aziz, M.D. Page 5

4) Christopher Moy, Muhammad U. Aziz,Joel Greshock, Stephen Szabo, Elizabeth McNeil, Junping Jing, Theresa Conway, Yan Degenhardt, Richard Wooster, Kurtis Bachman. Mutation and copy number detection in human cancers using a custom genotyping assay. Genomics. 2011 Oct; 98(4):296-301. Cited in PubMed; PMID; 2160027

5) Moy C, Aziz MU,Greshock J, Szabo S, McNeil E, Jing J, Conway T, Degenhardt Y, Wooster R, Bachman K. High-throughput mutation profiling and copy number detection in human cancers using a customized SNP genotyping assay. ASCO. 2010 Molecular Markers: 75 6) Ma C, Quesnelle KM, Sparano A, Rao S, Park MS, Cohen MA, Wang Y, Samanta M, Kumar MS, Aziz MU, Naylor TL, Weber BL, Fakharzadeh SS, Weinstein GS, Vachani A, Feldman MD, Brose MS. Characterization CSMD1 in a large set of Primary lung, head and neck, breast and skin cancer tissues. Cancer Biol Ther. 2009 May; 8(10): 907-916. Cited in PubMed; PMID: 19276661 7) Park MS, Ma C, Aziz MU,Rao S, Gold K, Samanta M, Guttman M, Grant GR, Vachani A, Brose MS. Genomic copy number alterations in non-small cell lung cancers identified using CBS and MSA. J Clin Oncol. 2007 Jun; 25(18S): 7695

8) Fatima S, Sheikh S, Aziz MU, Aftab O. Primary mediastinal germ cell tumor - successful curative resection following chemotherapy - a case report. J Pak Med Assoc. 2006 Apr; 56(4): 188-190. Cited in PubMed; PMID: 16711344

9) Mosse YP, Greshock J, Margolin A, Naylor T, Cole K, Khazi D, Hii G, Winter C, Shahzad S, Aziz MU, Biegel JA, Weber BL, Maris JM. High resolution detection and mapping of genomic DNA alterations in neuroblastoma. Genes Chromosomes Cancer. 2005 Aug; 43(4): 390-403. Cited in PubMed; PMID: 15892104

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