Project Manager Management

KAMRAN MANSOURY

*** **** *** ******, ************, IN

Phone: 832-***-****

E-Mail: **************@*****.***

PROFILE

I am a senior project manager, research scientist, and cross functional

leader with 15 years of experience in bio-pharmaceutical industry, and

academia. I have directed clinical development of multi-center programs in

all phases of study life cycle, including start-up, interim, and close out

stage. I have helped in design and clinical development of a novel class of

anti-infective drugs, as well as an anti-infective drug design program for

tuberculosis. I have made significant contributions in managing multi-phase

clinical trials for Solanezumab, Cialis, Alimta, Cymbalta, Zyprexa,

Strattera, Effient, and Axiron, to name a few.

I am proficient in FDA, EMEA, and NIH procedures, rules and regulations, as

well as GCP and ICH. I am also an expert in operations, risk management,

budgeting, forecasting, capacity planning, variance explanations, change

management, plan implementation, cost containing measure, regulatory

submissions, EMR, eCRF InForm Software System for Global Clinical Data

Management and Operations, Planisware and TrackWise softwares. I am

creative, have an analytical mind, and I believe that my combined

personality, back ground and experience make me extremely suited for a

dynamic, positive, and ever-growing organization.

PROFESSIONAL EXPERIENCE

Senior Project Manager

Eli Lilly & Company

January 2012 - Present

- Senior Project Manager at Global Statistical Sciences and Advanced

Analytics

- Responsible for managing activities and resources of multi-

phase/multi-center clinical trials in Neuroscience, Cardiovascular,

and Urology

- Significantly improved departmental efficiency by implementing

internal tracking software, database integrations, and project

management methodologies

- Managing timelines and milestones achievements for multi-center

clinical trials, data locks, data quality and transfers, Trial-Level

Risk Management, annual reports, regulatory submissions, and

regulatory responses, as well as external vendors and contractor's

interactions

- Significantly increased efficiency in clinical timeline management,

by developing a new Tracking database, to better visualize ongoing and

upcoming activities and timelines

- Improved clinical work flow by integrating internal database, to

manage costs, resources and to conduct forecasting

- Planisware software / Business Costing Model data management.

Variance explanation.

- Change management. Database migration from internal forms to

Planisware software

- TrackWise software for Deviation Management and deviation impact

analysis. Risk Mitigation and Management

- SAS Drug Development and SDD Integration Broker software data

sharing. Data Transfer between the companies any collaborators in the

US and Global Affiliates

- Interaction with CRO and TPOs, for U.S., and Global Trials

- CRO trail management, Project related task coordination, conflict

resolution. Bridging sponsor required tasks with CROs in EU, Japan,

and China

- Coordinate creation, analysis and submission of Analytical Data Sets

(ADS), ADS requirements, ADS programming, TFL requirements, TFL

programming and TFL production

- Plan and manage Integrated Data Bases activities, Data Mining,

Statistical Analysis Plan, Abstracts, Manuscripts and Posters related

to clinical studies

- Budgeting, Capacity Planning, Forecasting, Resourcing of different

Programs in the Department

- CROs / external vendor's relations

- System integration of Planisware to track and manage therapeutic

pipeline

- Development of new compound/trials tracking systems and data bases

within the Neuroscience, Cardio Vascular and Urology department

Program Manager, Clinical Development and Management

Global Allied Pharmaceuticals, CRO/BPO Company

July 2008 - December 2011

- Demonstrated a high degree of project management and integrated

project planning skills

- Provide leadership and expertise to project teams responsible for

the clinical development planning of new products

- Interaction with sponsors and clinical teams, thought leads

physician specialists, health economists, and clinical development

consulting groups to provide the best medical/scientific direction and

strategy for each drug candidate indication

- Provide leadership and strategic direction for the development and

execution of multiple clinical programs. Leadership role in

advancing clinical development programs across R&D departments, and

regulatory agencies

- Electronic Medical Record (EMR) use for patient enrollment

- Life cycle management. Leadership role in the review and oversight

of oncology trials globally (Phases I-IV)

- Project planning for protocol writing and reviews, selection of

external resources, assessment of clinical results, review of final

reports, monitoring budget, resources and time lines

- Managed teams to prepare/review clinical documents, including

Protocol, CSR, IND, and NDA

- Leadership role in planning and communicating with Regulators, such

as FDA and EMEA

- Participate with outside consultants in clarifying and defining

efficacy and safety standards for assigned new drug development

programs

- Worked with cross-functional teams to ensure adequate resource

allocation to projects

- Developed/implemented study process documents, monitoring plans,

monitoring reports, and study templates.

- Identified project risks and implemented mitigation strategies

- Identified and qualified investigators, and investigative sites

Research and Development Project Manager / Staff Scientist

Institute Of Biosciences and Technology, Texas A&M University / Houston

Medical Center

July 2006 - July 2008

- Created new and automated data management tools for structure guided

drug design and vaccine development for tuberculosis

- LIMS design and implementation

- Demonstrated successful experience working with complex cross-

functional project team

- Feasibility study for new drug development programs

- Assisted in the management of an active pipeline in pre-clinical

research

- Project Manager and the Scientist in charge of Research and

Development/technology transfer team

- Reviewed protocols, SOPs and ensured adherence to GCP. Worked with

QA on regulatory. Remained current on FDA and NIH rules and

regulations

- A member of International Tuberculosis Structural Genomics

Consortium. A high exposure representative of the team in the cross

functional and joint venture team

Research Project Manager / Scientist 3

AFFINIUM PHARMACEUTICALS / Pfizer Collaboration

June 2001 - July 2006

- Project Coordinator and team member of the Structural Biology Group,

responsible for determination of more than 30 Pfizer/Affinium High

Activity Drug Targets and Fragment Based Drug Design during 3 years of

the two companies' collaboration

- Structure guided drug development and Fragment Based Drug Design

hands on research

- Small molecule development and anti-infective phases I-II trials

- Participated in development of trial plans such as protocol

development, trial strategies, trial budgets, site selection, and

clinical supplies management

- LIMS and automation design, testing, and implementation

- Managing overall site staff, HR, overseeing clinical operations such

as recruiting, sampling and visit scheduling. Site monitoring

experience

- Review of regulatory documents, participated in the development of

draft protocol, template informed consent and study documents. Helped

preparing site coordinators manual, and source documents. Organized

reporting of AEs and SAEs from clinical trials and in accordance with

Company's SOPs and guidelines

Research Associate

MDS PROTEOMICS

August 2000 June 2001

- Small molecules development and design for new oncology drugs

- Data management of protein-protein interactions in several projects,

including the mapping of the yeast Saccharomyces cerevisiae protein

interactions

- LIMS implementation and testing

- Proteomics analysis of millions of DNA sequences, protein

interactions, and Mass Spec. identified protein and gene fragments,

relevant in different cancer research programs world wide

- Helped establishing the tissue culture and mammalian research

laboratory, building the company from a single room into a $350M

venture

1 Research Assistant

2 York University

September 1998 - August 2000

- In this research position at the Laboratory of Sir. Kenneth Davey,

performed extensive research in order to identify Membrane Protein

Receptors for Thyroxine (T3) and Juvenile Hormone on the Follicle

Cells of the insect Lacusta migratoria

- Proof-of-concept experimental design and execution. Generated high

quality experimental data that contributed to publication of number of

research papers in zoological publications

PUBLICATIONS

Co-author of four structure biology papers in bacterial drug targets and

small molecule drugs in Protein Data Bank (NCBI-PDB); Co-author of sixty

four patents in Structure Biology and Structure Guided Drug Design;

Citations in Dawn Webster on Novel Essential Bacterial Polypeptides.

TECHNICAL SKILLS

SAS Drug Development, SDD Integration Broker, Planisware Data Management,

Deviation Management, TrackWise, Critical Chain Project Management, Six

Sigma

Databases: Protein Data Bank, NCBI, PubMed, Entrez, LIMS

Desktop: MS Word, MS PowerPoint, MS Excel, MS Project, Photo shop

EDUCATION

B. Sc., Biology, York University, 2000

Biological Chemical Technology, Seneca College, 1995

REFERENCES

AVAILABLE UPON REQUEST

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