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HANAA ABDEL-MAGUID
Mobile: +2 0100 898 6775 / +2 0114 114 9077
Email: Hanaa.AbdelMaguid@gmail.com
CAREER OVERVIEW
I am a pharmaceutical management professional with experience of 8 years in the pharmaceutical sales and
marketing, 1.5 years in administrative corporate management, 5 years in the research and development
innovation project management, 1.5 years as a Medical Director, and one year as a CRO Managing Director. I
have worked in multinational and Egyptian pharmaceutical companies with a proven track record of developing
new business and motivating cross-functional teams to consistently achieve action plans. I've completed a
Doctorate of Business Administration with distinction and looking for interesting opportunities in the
pharmaceutical research field in which my skills set can add value to an organization with the goal of benefiting
humanity. I am willing to relocate.
KEY STRENGTHS
o Knowledge of drug development process and ability to apply GCP & GVP guidelines.
o Excellent research, scientific writing and editing skills.
o Energetic, self-starter – ability to work independently.
o Integrity, initiative and adaptability.
o Excellent organisational, planning and leadership skills
o Excellent communication, interpersonal and presentation skills
o Outstanding analytical and problem-solving abilities
o Thorough knowledge of market changes and forces influencing business
o Strong understanding of corporate finance and measures of performance
o Familiarity with corporate law and management best practices
o High stress tolerance and ability to make difficult decisions.
o Strong interpersonal skills and customer focus.
o Strong business development capabilities.
o High level corporate administrative management skills.
o Excellent computer skills including Excel, Word, PowerPoint, and Project Office.
o Fluent in both English and French (speaking and writing).
CAREER HISTORY
Dec. 2016 – Nov. 2017: Vice Chairman, Managing Director& Head of Business Development
TCD MENA, Egypt
TCD MENA is a sister company of TCD Global CRO that was established in South Africa in 2000. TCD is a Full
service CRO with additional services with established vendors, and experience across multiple therapeutic areas
over 250 contracts, 48,000 participants, 800 sites in 20 countries with clients and sponsors including PDPs,
Biotech, Pharma, Academia, Global CROs, BioPharma, NGOs, Government and Academic Research Organisations
(AROs) with more than 80% repeat business. TCD manages clinical trials including: Bio-equivalence,
Epidemiology, Phase I – IV trials, FIH. TCD offers in-house competence, in any required combination, of the full
CRO services.
Page 2 of 8
Key Responsibilities
1. Develop and execute the company’s business strategies in order to attain the goals of the board and
shareholders
2. Provide strategic advice to the board and Chairperson so that they will have accurate view of the market
and the company’s future
3. Prepare and implement comprehensive business plans to facilitate achievement by planning cost-
effective operations and market development activities
4. Ensure company policies and legal guidelines are communicated all the way from the top down in the
company and that they are followed at all times
5. Communicate and maintain trust relationships with shareholders, business partners and authorities
6. Oversee the company’s financial performance, investments and other business ventures
7. Delegate responsibilities and supervise the work of executives providing guidance and motivation to
drive maximum performance
8. Read all submitted reports by lower rank managers to reward performance, prevent issues and resolve
problems
9. Act as the public speaker and public relations representative of the company in ways that strengthen
its profile
10. Analyse problematic situations and occurrences and provide solutions to ensure company survival and
growth
11. Provide leadership & medical expertise in the development of clinical research strategic programs in
line with global strategy.
12. Work closely and cooperatively with research centers locally & globally to ensure the organisation
contributes to the global development of new chemical entities.
13. Establish ongoing liaison with key opinion leaders, government officials, MOH staff &healthcare
organisations to ensure that significant developments in the field are identified and monitored.
14. Provide the planning and leadership by ensuring that appropriate structures, systems, competencies
&values are developed.
Key Achievements
 Establishment TCD MENA CRO Office in Cairo & Managing successful registration in RHD-MOH
 Creation of vendor qualification system and having strong qualified vendors network
 Contribution in the creation/update of TCD Global SOPs
 Successful completion & publication of a manuscript for a Phase IIb/IIIa Clinical Trial in Journal of Hepatology
 Managed several R&D partnership agreements with local and international entities.
March 2015 – November 2016: Medical Director
European Egyptian Pharmaceutical Industries (EEPI) - Pharco Corporation, Egypt
Pharco Corporation is a group of pharmaceutical companies the first of which is Pharco Pharmaceuticals that
was established in 1982. Its principal activity consists of discovering, developing, manufacturing, and marketing
medicines. It is located in Alexandria, Egypt. It is one of the main players in the market of Egyptian
Pharmaceutical Industry. The R&D orientation of Pharco Corporation lead to having three innovative products
in the market, and a number of innovation projects in the pipeline.
Page 3 of 8
Key Responsibilities
1. Provide leadership & medical expertise in the development of clinical research strategic programs in
line with global strategy and to support local product registration and marketing.
2. Act as a medical resource to the company as a whole & particularly to the clinical research department.
3. Work closely and cooperatively with research centers locally & overseas to ensure the organisation
contributes to the global development of new chemical entities.
4. Develop clinical trial programs to support product registration &marketing.
5. Provide medical & scientific input to product development teams.
6. Provide medical expertise in the review of adverse experiences locally & contribute to global
pharmacovigilance activities.
7. Actively participate on Medicines committees &analyse regular Medicines correspondence with follow-
up and discussion with internal colleagues &other industry participants on relevant issues.
8. Establish ongoing liaison with key opinion leaders, government officials, MOH staff &healthcare
organisations to ensure that significant developments in the field are identified and monitored.
9. Represent the company at MOH discussions regarding the registration of new chemical entities.
10. Provide the planning and leadership to the Medical Department by ensuring that appropriate
structures, systems, competencies &values are developed.
11. Ensure that the interfaces between Medical &other departments are managed optimally.
12. Form informal networks with company senior management, updating them on a regular basis on
developments within Medical &progress made with the clinical and regulatory program.
13. In conjunction with local senior management develop strategic product plans whereby both new
chemical entities & existing products are considered by Clinical, Regulatory, Marketing, and Financial
people through cross-functional teams, to ensure timely entry of new compounds to the market and
the ongoing market success of existing products.
14. Have responsibility for the financial management of the R&D program including budget planning,
resource allocation and preparation of quarterly reports.
15. Work with clinical management to determine headcount requirements for clinical programs, and be
involved with the identification and selection of suitable candidates for positions.
16. Ensure effective team communication throughout the department through the application of suitable
reporting systems and structures and the identification and provision of appropriate training.
Key Achievements
 Established Medical Affairs Department & Created Medical Affairs SOPs
 Established Pharmacovigilance Department & Managed the creation of PSMF & PV SOPs approved by EPVC
 Established In-House Clinical Operations Department and managed the creation of Clinical Research SOPs
 Managed the authorship of the protocols & study documents of two Phase II Clinical Trials
 Successful completion of a Phase IIb/IIIa Clinical Trial with contribution in creation of approved late breaker
abstract and oral presentation in AASLD 2015 & Best Poster in EASL 2016.
 Managed several R&D partnership agreements with local and international entities.
July 2013 – March 2015: R&D Innovation Projects Head
Pharco Corporation, Egypt
Key Responsibilities
1. Provide input into the company’s studies from an operational perspective. Implement approved
protocols and operational plans, and assume primary accountability for the ongoing progress of those
plans on assigned studies.
2. Involvement in selection of CROs and sites.
Page 4 of 8
3. Manage and oversee CROs/sites.
4. Manage resources and timelines associated with all study activities.
5. Manage study support personnel to achieve the project goals and objectives.
6. Assist with the appropriate development of all documents by vendors including but not limited to
project-specific documents required for the conduct of assigned studies.
7. Assume primary accountability for assigned projects and ensures compliance with applicable
regulations, guidelines, and corporate policies for study activities.
8. Ensure the development and maintenance of project-specific tracking systems to enable proper study
management and monitoring activities, as required.
9. Develop and maintain detailed timelines and resource projections for assigned programs.
10. Provides routine status reports and updates regarding the progress of projects.
11. Plan for and manage all materials to support the appropriate execution of the pre-clinical and clinical
projects, including but not limited to distribution of documents, forms, supplies, equipment, laboratory
supplies, and devices.
12. Prepare internal and external memos, reports, documents, and correspondence required to properly
manage and document activities on the studies.
13. Ensure maintenance of project files according to applicable regulations, guidelines, and corporate
policy (e.g. GCPs and company procedures).
14. Manage the day-to-day operational and tactical aspects of multiple projects.
15. Review deliverables across projects.
16. Manage scope and mitigate risk across multiple projects.
Key Achievements
 Initiated and managed one Phase IIIb, two Phase II clinical trials and one Phase IIb/IIIa clinical trial.
 Initiated and managed several Bioequivalence PK studies.
 Initiated and managed several efficacy, safety & bioavailability animal studies.
 Initiated and managed several R&D partnership agreements with local and international entities.
June 2010 – June 2013: R&D Innovation Projects Manager
Pharco Corporation, Egypt
Key Responsibilities
1. Support and contribute to establishment and documentation of appropriate strategies, deliverables
and comprehensive cross-functional project plans for new product development projects (e.g. task
analysis, work breakdown structures, time and event schedules, cost projections, resource
requirements and risk/contingency plans).
2. Assist and participate in cross-functional team activities to achieve defined project objectives supplying
appropriate monitoring, control and tracking of project status vs. plan.
3. Maintain accurate and up-to-date project records, cross-functional communications and variance
analysis (activity, resources and cost).
4. Support and facilitate effective communication between cross-functional team members and outside
business partners world-wide.
5. Document and report progress, status and issues to project teams and top management.
6. Support and contribute to implementation of latest project and portfolio management
tools/techniques with the R&D organization as well as cross-functional areas supporting new product
development.
Page 5 of 8
Key Achievements
 Initiated and managed one Phase II, one Phase IV, and one Phase IIIB clinical trial.
 Initiated and managed several efficacy, safety & Bioavailability animal studies.
 Assisted in the establishment of Tissue Culture & Molecular Medicine Laboratory that works in partnership
with Michigan University-USA.
 Initiated and managed several R&D partnership agreements with local and international entities.
Feb. 2009 – June 2010: President’s Technical Assistant
Pharco Corporation, Egypt
Key Responsibilities
1. Prepare or assist in the preparation of reports as required including financial and statistical reports, annual
reports and regular reporting to the CEO.
2. Attend meetings with outside bodies as a representative of the CEO and reporting thereon.
3. Prepare different materials necessary for talks, lectures, and presentations for use inside the corporation
or to external bodies, and if required participate in the presentation of these activities.
4. Follow-up the overall tasks of the following departments: Corporate Strategic Planning, Corporate Human
Resources, Corporate Budgeting& Finance, Corporate Data Mining, Corporate ERP, Corporate Registration
(Local & International), Corporate Research & Development, Sales& Marketing, and Public Relations related
to the CEO.
5. Follow-up on the execution of new projects: Research & Analysis of potential opportunities, Contact with
partners in local & international projects, Feasibility analysis of new investments.
6. Other Follow-up activities: Meetings' analysis, documentation and reporting to the CEO, corporate
performance and achievements, social activities of the CEO in different communities.
March 2001– Feb. 2009: Product Specialist
MSD (Merck Sharp & Dohme), Egypt
Key Responsibilities
o Executive Product Specialist on PROSCAR responsible for Alexandria& Delta: Feb. 2007 –Feb. 2009.
o Senior Product Specialist on PROSCAR responsible for Alexandria& Delta: Feb. 2004 –Feb. 2007.
o Product Specialist on PROSCAR responsible for Alexandria& Delta: Jan. 2003-Jan. 2004.
o Product Specialist-Intensive Care on AGGRASTAT responsible for Alexandria& Delta: Feb. 2002-Dec. 2002.
o Medical Representative on VIOXX& FOSAMAX responsible for East Alexandria: March 2001-Jan. 2002.
Oct. 2000– Feb. 2001: Medical Representative
SCOPE (Scientific office for promotion of AVENTIS products), Egypt
o Medical Representative promoting ROVAMYCIN, BI-PROFENID, FLAGENTYL, PROFENID GEL, MELROSUM,
and BRONCHICUM responsible for West Alexandria.
1998 – Oct. 2000: Pharmacist
Community Pharmacies
 Second Pharmacist responsible for dispensing prescription and OTC drugs, managing inventory and orders in
El-Khalifa Pharmacy: Sept- Oct. 2000.
 Second Pharmacist responsible for dispensing prescription and OTC drugs, managing inventory and orders in
El-Beaurivage Pharmacy: Aug-Sept. 2000.
 Training as a second pharmacist in Ashraf Pharmacy: July 2000.
 Summer training as a pharmacy student in Al-Hammad Pharmacy: 1999 & in Moftah Pharmacy: 1998.
 Training as a pharmacy student in Pharco Pharmaceuticals Company: Aug.1999.
Page 6 of 8
EDUCATION & TRAINING
 Nov. 2008 – July 2013, Graduate School of Business (GSB), Arab Academy for Science, Technology & Maritime
Transport (AASTM): Doctorate of Business Administration (DBA), Grade: Excellent with Honour Degree,
Cumulative GPA: 3.97.
 Mar. 2004 – Oct. 2005 Graduate School of Business (GSB), Arab Academy for Science, Technology& Maritime
Transport (AASTM): Master of Business Administration (MBA), Grade: Excellent with Honour Degree,
Cumulative GPA: 4.0.
 Sep. 1995 – June 2000 Faculty of Pharmacy, Alexandria University:
Bachelor of Pharmaceutical Sciences, Grade: Very Good with Honour Degree.
TCD Global
o Investigational Product Management: from a monitor’s perspective: Fundamentals and Scenarios
including unblinded monitoring (May, 2017)
o Quality Assurance: The Audit process and lessons learned for improving the monitoring process
and performance (April, 2017)
o Web based REC Applications (April, 2017)
o Nukleus: Monitoring & Engaging with the Site (March, 2017)
o Updated ICH-GCP E6 (R2) Guidelines (January, 2017)
o Introduction to Nukleus EDC System (Building a Study (January, 2017)
o Skills Transfer and Training in Clinical Research Methodology - South Africa (September, 2016).
Pharco Corporation
o Global Bioequivalence, Harmonization Symposium- ACDIMA, Jordan (May, 2016).
o Clinical Monitoring – EEPI (March, 2016).
o Pharmacovigilance Specialist Training Program-6 Waves - AUPAM (March, 2016).
o Arab Guidelines of Pharmacovigilance - Wave VI- AUPAM (March, 2016).
o Introduction to Biostatistics - EEPI (February, 2016).
o Good Clinical Practices - Clinical Trials Network, NIDA (November 2015).
o ICH-GCP in Clinical Research Training Workshop for Monitors - EEPI (April 2015).
o Bioequivalence Studies: Theory & Practice – ACDIMA, Jordan ( 01-30 October 2014)
o Arab Guidelines of Pharmacovigilance - Wave IV - AUPAM (September 2014).
o Arab Guidelines of Pharmacovigilance - Wave III - AUPAM (August 2014).
o Arab Guidelines of Pharmacovigilance - Wave II - AUPAM (June 2014).
o Arab Guidelines of Pharmacovigilance - Wave I - AUPAM (May 2014).
o ICH-GCP in Clinical Research – SCIDRE (April 2014).
o Project Management Professional (PMP) Exam Preparation Training- Dubai (December 2013).
o Stem Cells Workshop -VACSERA (December 2013).
o Tissue Engineering Workshop -VACSERA (October 2013).
o e-CTD Management (June 2013).
o Introduction to Mass Spectrometry and its Applications in Drug Metabolism (June 2013).
o Knowledge Management (Aug. 2012).
o SOP, MedDRA Coding, Pharmacovigilance Inspection-QPPV (June 2012).
o Tissue Engineering - 4 Credit hours (April 2012).
o Basic Statistical Techniques using SPSS- MRI (Feb. 2012).
o Reference and Data Management using Endnote-X4 – MRI (May 2011).
o Statistics for non-Statisticians - SCIDRE (April 2011).
Merck Sharp & Dohme
o Effective Meetings (Nov. 2007).
Page 7 of 8
o Merck Marketing Faculty (Nov. 2006 - Aug. 2007).
o Professional Selling (May 2007).
o PC-Styles; Professional Communication Styles (March 2006).
o Effective Presentation Skills (Feb. 2005).
o PC Reprint; Professional Communication –Reprint (June 2004).
o High Impact Selling Techniques (Jan. 2003).
o GCS; Group Communication Skills (April 2002).
o PC-2; Professional Communication-2 (April, 2002).
o Hospital Territory Management (Feb. 2002).
o Master Territory Management (Aug. 2001).
o PC-1; Professional Communication-1 (April 2001).
SCOPE (Scientific office for promotion of AVENTIS products)
o SSAW; Selling Skills Advanced Workshop (Oct. 2000).
o SSTC; Selling Skills Training Course (July 2000).
Continuing Education
Clinical Research, Medical Writing & Data Management
 John Hopkins University / Coursera, Design and Interpretation of Clinical Trials, Distinction (Feb. 2014 –
March 2014).
 Harvard University - Harvard School of Public Health, Harvard Medicine School /edX, HSPHHMS214x:
Fundamentals of Clinical trials. Distinction (Nov. 2013 – Feb. 2014).
 Rice University / Coursera, Nanotechnology: The Basics (Nov. 2013 – Dec. 2013).
 Stanford University - School of Medicine, Writing in the Sciences (Sep. 2013 – Nov. 2013).
 University of Texas Austin /edX – Take Your Medicine – The Impact of Drug Development, Distinction
(Sep. 2013 – Nov. 2013).
 Vanderbilt University / Coursera, Data Management for Clinical Research (Sep. 2013 – Oct. 2013).
 Stanford University - School of Medicine / Coursera, Practical Tips to Improve Asian American
Participation in Cancer Clinical trials, Distinction (Sep. 2013).
 John Hopkins University - Bloomberg School of Public Health / Coursera, Vaccine Trials: Methods and
Best Practices. Distinction (June 2013 – Aug. 2013).
 University of California - San Diego Skaggs School of Pharmacy & Pharmaceutical Sciences /
Coursera, Drug Discovery, Development & Commercialization, International Team Project: Life Cycle
Strategic Plan Development, Distinction (April 2013 – July 2013).
 Harvard University - Harvard School of Public Health /edX, PH207x: Health in Numbers: Quantitative
Methods in Clinical & Public Health Research. Distinction (Nov. 2012 – Jan 2013).
Biology
 Ludwig-Maximilians-Universität München (LMU) / Coursera, Programmed Cell Death, Distinction (July
2013 – Aug. 2013).
 MIT “Massachusetts Institute of Technology” / edX, Molecular Biology: The Secret of Life, (March
2013 – June 2013).
Business Administration
 Ludwig-Maximilians-Universität München (LMU) – Institute for Strategy, Technology & Organization /
Coursera, Competitive Strategy, Distinction (July 2013 – Aug. 2013).
Philosophy
 Harvard University / edX, Political Philosophy: Justice, Distinction (March 2013 – July 2013).
 Edinburgh University - School of Philosophy / Coursera, Introduction to Philosophy, Distinction (Jan.
2013 – Feb. 2013).
 Duke University / Coursera, Logic & Philosophy: Think Again: How to Reason & Argue, Distinction (Nov.
2012 – Jan. 2013).
Page 8 of 8
PARTICIPATION IN CONFERENCES & WORKSHOPS
Conferences
 Speaker in CRC Networking Day, “Clinical Research Overview in Egypt & MENA Region” (21 Feb. 2017)
 Speaker in CVCT (Cardio-Vascular Clinical Trialists) International Conference, “Clinical Research
Overview in Egypt & MENA Region” (22 Sep. 2017)
GCP Workshops
 Instructor in Armed Forces College of Medicine (AFCM) GCP Workshop (27, 28 Feb. 2017)
 Instructor in National Research Center GCP Workshop (15 May 2017)
 Instructor in TCD MENA GCP Workshop (9, 10 Oct 2017).
PUBLICATIONS
Esmat G et al. Effectiveness of ravidasvir plus sofosbuvir in interferon-naive and treated patients with chronic
hepatitis C genotype-4. J Hepatol (2017), https://doi.org/10.1016/j.jhep.2017.09.006
LANGUAGES
 Arabic: Mother language.
 English: Bilingual proficiency.
 French: Professional working proficiency.
PERSONAL DATA
 Date of Birth: July 1st
1978
 Nationality: Egyptian
 Address: 426 Gamal Abdel-Nasser St., Mandara, Alexandria, Egypt.
 Marital Status: Single
 Interests: Research, Internet Browsing, Movies, Readings: Strategy, Business, Medicine, Marketing,
Philosophy, Psychology, History, and Novels.

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Pharmaceutical executive resume

  • 1. Page 1 of 8 HANAA ABDEL-MAGUID Mobile: +2 0100 898 6775 / +2 0114 114 9077 Email: Hanaa.AbdelMaguid@gmail.com CAREER OVERVIEW I am a pharmaceutical management professional with experience of 8 years in the pharmaceutical sales and marketing, 1.5 years in administrative corporate management, 5 years in the research and development innovation project management, 1.5 years as a Medical Director, and one year as a CRO Managing Director. I have worked in multinational and Egyptian pharmaceutical companies with a proven track record of developing new business and motivating cross-functional teams to consistently achieve action plans. I've completed a Doctorate of Business Administration with distinction and looking for interesting opportunities in the pharmaceutical research field in which my skills set can add value to an organization with the goal of benefiting humanity. I am willing to relocate. KEY STRENGTHS o Knowledge of drug development process and ability to apply GCP & GVP guidelines. o Excellent research, scientific writing and editing skills. o Energetic, self-starter – ability to work independently. o Integrity, initiative and adaptability. o Excellent organisational, planning and leadership skills o Excellent communication, interpersonal and presentation skills o Outstanding analytical and problem-solving abilities o Thorough knowledge of market changes and forces influencing business o Strong understanding of corporate finance and measures of performance o Familiarity with corporate law and management best practices o High stress tolerance and ability to make difficult decisions. o Strong interpersonal skills and customer focus. o Strong business development capabilities. o High level corporate administrative management skills. o Excellent computer skills including Excel, Word, PowerPoint, and Project Office. o Fluent in both English and French (speaking and writing). CAREER HISTORY Dec. 2016 – Nov. 2017: Vice Chairman, Managing Director& Head of Business Development TCD MENA, Egypt TCD MENA is a sister company of TCD Global CRO that was established in South Africa in 2000. TCD is a Full service CRO with additional services with established vendors, and experience across multiple therapeutic areas over 250 contracts, 48,000 participants, 800 sites in 20 countries with clients and sponsors including PDPs, Biotech, Pharma, Academia, Global CROs, BioPharma, NGOs, Government and Academic Research Organisations (AROs) with more than 80% repeat business. TCD manages clinical trials including: Bio-equivalence, Epidemiology, Phase I – IV trials, FIH. TCD offers in-house competence, in any required combination, of the full CRO services.
  • 2. Page 2 of 8 Key Responsibilities 1. Develop and execute the company’s business strategies in order to attain the goals of the board and shareholders 2. Provide strategic advice to the board and Chairperson so that they will have accurate view of the market and the company’s future 3. Prepare and implement comprehensive business plans to facilitate achievement by planning cost- effective operations and market development activities 4. Ensure company policies and legal guidelines are communicated all the way from the top down in the company and that they are followed at all times 5. Communicate and maintain trust relationships with shareholders, business partners and authorities 6. Oversee the company’s financial performance, investments and other business ventures 7. Delegate responsibilities and supervise the work of executives providing guidance and motivation to drive maximum performance 8. Read all submitted reports by lower rank managers to reward performance, prevent issues and resolve problems 9. Act as the public speaker and public relations representative of the company in ways that strengthen its profile 10. Analyse problematic situations and occurrences and provide solutions to ensure company survival and growth 11. Provide leadership & medical expertise in the development of clinical research strategic programs in line with global strategy. 12. Work closely and cooperatively with research centers locally & globally to ensure the organisation contributes to the global development of new chemical entities. 13. Establish ongoing liaison with key opinion leaders, government officials, MOH staff &healthcare organisations to ensure that significant developments in the field are identified and monitored. 14. Provide the planning and leadership by ensuring that appropriate structures, systems, competencies &values are developed. Key Achievements  Establishment TCD MENA CRO Office in Cairo & Managing successful registration in RHD-MOH  Creation of vendor qualification system and having strong qualified vendors network  Contribution in the creation/update of TCD Global SOPs  Successful completion & publication of a manuscript for a Phase IIb/IIIa Clinical Trial in Journal of Hepatology  Managed several R&D partnership agreements with local and international entities. March 2015 – November 2016: Medical Director European Egyptian Pharmaceutical Industries (EEPI) - Pharco Corporation, Egypt Pharco Corporation is a group of pharmaceutical companies the first of which is Pharco Pharmaceuticals that was established in 1982. Its principal activity consists of discovering, developing, manufacturing, and marketing medicines. It is located in Alexandria, Egypt. It is one of the main players in the market of Egyptian Pharmaceutical Industry. The R&D orientation of Pharco Corporation lead to having three innovative products in the market, and a number of innovation projects in the pipeline.
  • 3. Page 3 of 8 Key Responsibilities 1. Provide leadership & medical expertise in the development of clinical research strategic programs in line with global strategy and to support local product registration and marketing. 2. Act as a medical resource to the company as a whole & particularly to the clinical research department. 3. Work closely and cooperatively with research centers locally & overseas to ensure the organisation contributes to the global development of new chemical entities. 4. Develop clinical trial programs to support product registration &marketing. 5. Provide medical & scientific input to product development teams. 6. Provide medical expertise in the review of adverse experiences locally & contribute to global pharmacovigilance activities. 7. Actively participate on Medicines committees &analyse regular Medicines correspondence with follow- up and discussion with internal colleagues &other industry participants on relevant issues. 8. Establish ongoing liaison with key opinion leaders, government officials, MOH staff &healthcare organisations to ensure that significant developments in the field are identified and monitored. 9. Represent the company at MOH discussions regarding the registration of new chemical entities. 10. Provide the planning and leadership to the Medical Department by ensuring that appropriate structures, systems, competencies &values are developed. 11. Ensure that the interfaces between Medical &other departments are managed optimally. 12. Form informal networks with company senior management, updating them on a regular basis on developments within Medical &progress made with the clinical and regulatory program. 13. In conjunction with local senior management develop strategic product plans whereby both new chemical entities & existing products are considered by Clinical, Regulatory, Marketing, and Financial people through cross-functional teams, to ensure timely entry of new compounds to the market and the ongoing market success of existing products. 14. Have responsibility for the financial management of the R&D program including budget planning, resource allocation and preparation of quarterly reports. 15. Work with clinical management to determine headcount requirements for clinical programs, and be involved with the identification and selection of suitable candidates for positions. 16. Ensure effective team communication throughout the department through the application of suitable reporting systems and structures and the identification and provision of appropriate training. Key Achievements  Established Medical Affairs Department & Created Medical Affairs SOPs  Established Pharmacovigilance Department & Managed the creation of PSMF & PV SOPs approved by EPVC  Established In-House Clinical Operations Department and managed the creation of Clinical Research SOPs  Managed the authorship of the protocols & study documents of two Phase II Clinical Trials  Successful completion of a Phase IIb/IIIa Clinical Trial with contribution in creation of approved late breaker abstract and oral presentation in AASLD 2015 & Best Poster in EASL 2016.  Managed several R&D partnership agreements with local and international entities. July 2013 – March 2015: R&D Innovation Projects Head Pharco Corporation, Egypt Key Responsibilities 1. Provide input into the company’s studies from an operational perspective. Implement approved protocols and operational plans, and assume primary accountability for the ongoing progress of those plans on assigned studies. 2. Involvement in selection of CROs and sites.
  • 4. Page 4 of 8 3. Manage and oversee CROs/sites. 4. Manage resources and timelines associated with all study activities. 5. Manage study support personnel to achieve the project goals and objectives. 6. Assist with the appropriate development of all documents by vendors including but not limited to project-specific documents required for the conduct of assigned studies. 7. Assume primary accountability for assigned projects and ensures compliance with applicable regulations, guidelines, and corporate policies for study activities. 8. Ensure the development and maintenance of project-specific tracking systems to enable proper study management and monitoring activities, as required. 9. Develop and maintain detailed timelines and resource projections for assigned programs. 10. Provides routine status reports and updates regarding the progress of projects. 11. Plan for and manage all materials to support the appropriate execution of the pre-clinical and clinical projects, including but not limited to distribution of documents, forms, supplies, equipment, laboratory supplies, and devices. 12. Prepare internal and external memos, reports, documents, and correspondence required to properly manage and document activities on the studies. 13. Ensure maintenance of project files according to applicable regulations, guidelines, and corporate policy (e.g. GCPs and company procedures). 14. Manage the day-to-day operational and tactical aspects of multiple projects. 15. Review deliverables across projects. 16. Manage scope and mitigate risk across multiple projects. Key Achievements  Initiated and managed one Phase IIIb, two Phase II clinical trials and one Phase IIb/IIIa clinical trial.  Initiated and managed several Bioequivalence PK studies.  Initiated and managed several efficacy, safety & bioavailability animal studies.  Initiated and managed several R&D partnership agreements with local and international entities. June 2010 – June 2013: R&D Innovation Projects Manager Pharco Corporation, Egypt Key Responsibilities 1. Support and contribute to establishment and documentation of appropriate strategies, deliverables and comprehensive cross-functional project plans for new product development projects (e.g. task analysis, work breakdown structures, time and event schedules, cost projections, resource requirements and risk/contingency plans). 2. Assist and participate in cross-functional team activities to achieve defined project objectives supplying appropriate monitoring, control and tracking of project status vs. plan. 3. Maintain accurate and up-to-date project records, cross-functional communications and variance analysis (activity, resources and cost). 4. Support and facilitate effective communication between cross-functional team members and outside business partners world-wide. 5. Document and report progress, status and issues to project teams and top management. 6. Support and contribute to implementation of latest project and portfolio management tools/techniques with the R&D organization as well as cross-functional areas supporting new product development.
  • 5. Page 5 of 8 Key Achievements  Initiated and managed one Phase II, one Phase IV, and one Phase IIIB clinical trial.  Initiated and managed several efficacy, safety & Bioavailability animal studies.  Assisted in the establishment of Tissue Culture & Molecular Medicine Laboratory that works in partnership with Michigan University-USA.  Initiated and managed several R&D partnership agreements with local and international entities. Feb. 2009 – June 2010: President’s Technical Assistant Pharco Corporation, Egypt Key Responsibilities 1. Prepare or assist in the preparation of reports as required including financial and statistical reports, annual reports and regular reporting to the CEO. 2. Attend meetings with outside bodies as a representative of the CEO and reporting thereon. 3. Prepare different materials necessary for talks, lectures, and presentations for use inside the corporation or to external bodies, and if required participate in the presentation of these activities. 4. Follow-up the overall tasks of the following departments: Corporate Strategic Planning, Corporate Human Resources, Corporate Budgeting& Finance, Corporate Data Mining, Corporate ERP, Corporate Registration (Local & International), Corporate Research & Development, Sales& Marketing, and Public Relations related to the CEO. 5. Follow-up on the execution of new projects: Research & Analysis of potential opportunities, Contact with partners in local & international projects, Feasibility analysis of new investments. 6. Other Follow-up activities: Meetings' analysis, documentation and reporting to the CEO, corporate performance and achievements, social activities of the CEO in different communities. March 2001– Feb. 2009: Product Specialist MSD (Merck Sharp & Dohme), Egypt Key Responsibilities o Executive Product Specialist on PROSCAR responsible for Alexandria& Delta: Feb. 2007 –Feb. 2009. o Senior Product Specialist on PROSCAR responsible for Alexandria& Delta: Feb. 2004 –Feb. 2007. o Product Specialist on PROSCAR responsible for Alexandria& Delta: Jan. 2003-Jan. 2004. o Product Specialist-Intensive Care on AGGRASTAT responsible for Alexandria& Delta: Feb. 2002-Dec. 2002. o Medical Representative on VIOXX& FOSAMAX responsible for East Alexandria: March 2001-Jan. 2002. Oct. 2000– Feb. 2001: Medical Representative SCOPE (Scientific office for promotion of AVENTIS products), Egypt o Medical Representative promoting ROVAMYCIN, BI-PROFENID, FLAGENTYL, PROFENID GEL, MELROSUM, and BRONCHICUM responsible for West Alexandria. 1998 – Oct. 2000: Pharmacist Community Pharmacies  Second Pharmacist responsible for dispensing prescription and OTC drugs, managing inventory and orders in El-Khalifa Pharmacy: Sept- Oct. 2000.  Second Pharmacist responsible for dispensing prescription and OTC drugs, managing inventory and orders in El-Beaurivage Pharmacy: Aug-Sept. 2000.  Training as a second pharmacist in Ashraf Pharmacy: July 2000.  Summer training as a pharmacy student in Al-Hammad Pharmacy: 1999 & in Moftah Pharmacy: 1998.  Training as a pharmacy student in Pharco Pharmaceuticals Company: Aug.1999.
  • 6. Page 6 of 8 EDUCATION & TRAINING  Nov. 2008 – July 2013, Graduate School of Business (GSB), Arab Academy for Science, Technology & Maritime Transport (AASTM): Doctorate of Business Administration (DBA), Grade: Excellent with Honour Degree, Cumulative GPA: 3.97.  Mar. 2004 – Oct. 2005 Graduate School of Business (GSB), Arab Academy for Science, Technology& Maritime Transport (AASTM): Master of Business Administration (MBA), Grade: Excellent with Honour Degree, Cumulative GPA: 4.0.  Sep. 1995 – June 2000 Faculty of Pharmacy, Alexandria University: Bachelor of Pharmaceutical Sciences, Grade: Very Good with Honour Degree. TCD Global o Investigational Product Management: from a monitor’s perspective: Fundamentals and Scenarios including unblinded monitoring (May, 2017) o Quality Assurance: The Audit process and lessons learned for improving the monitoring process and performance (April, 2017) o Web based REC Applications (April, 2017) o Nukleus: Monitoring & Engaging with the Site (March, 2017) o Updated ICH-GCP E6 (R2) Guidelines (January, 2017) o Introduction to Nukleus EDC System (Building a Study (January, 2017) o Skills Transfer and Training in Clinical Research Methodology - South Africa (September, 2016). Pharco Corporation o Global Bioequivalence, Harmonization Symposium- ACDIMA, Jordan (May, 2016). o Clinical Monitoring – EEPI (March, 2016). o Pharmacovigilance Specialist Training Program-6 Waves - AUPAM (March, 2016). o Arab Guidelines of Pharmacovigilance - Wave VI- AUPAM (March, 2016). o Introduction to Biostatistics - EEPI (February, 2016). o Good Clinical Practices - Clinical Trials Network, NIDA (November 2015). o ICH-GCP in Clinical Research Training Workshop for Monitors - EEPI (April 2015). o Bioequivalence Studies: Theory & Practice – ACDIMA, Jordan ( 01-30 October 2014) o Arab Guidelines of Pharmacovigilance - Wave IV - AUPAM (September 2014). o Arab Guidelines of Pharmacovigilance - Wave III - AUPAM (August 2014). o Arab Guidelines of Pharmacovigilance - Wave II - AUPAM (June 2014). o Arab Guidelines of Pharmacovigilance - Wave I - AUPAM (May 2014). o ICH-GCP in Clinical Research – SCIDRE (April 2014). o Project Management Professional (PMP) Exam Preparation Training- Dubai (December 2013). o Stem Cells Workshop -VACSERA (December 2013). o Tissue Engineering Workshop -VACSERA (October 2013). o e-CTD Management (June 2013). o Introduction to Mass Spectrometry and its Applications in Drug Metabolism (June 2013). o Knowledge Management (Aug. 2012). o SOP, MedDRA Coding, Pharmacovigilance Inspection-QPPV (June 2012). o Tissue Engineering - 4 Credit hours (April 2012). o Basic Statistical Techniques using SPSS- MRI (Feb. 2012). o Reference and Data Management using Endnote-X4 – MRI (May 2011). o Statistics for non-Statisticians - SCIDRE (April 2011). Merck Sharp & Dohme o Effective Meetings (Nov. 2007).
  • 7. Page 7 of 8 o Merck Marketing Faculty (Nov. 2006 - Aug. 2007). o Professional Selling (May 2007). o PC-Styles; Professional Communication Styles (March 2006). o Effective Presentation Skills (Feb. 2005). o PC Reprint; Professional Communication –Reprint (June 2004). o High Impact Selling Techniques (Jan. 2003). o GCS; Group Communication Skills (April 2002). o PC-2; Professional Communication-2 (April, 2002). o Hospital Territory Management (Feb. 2002). o Master Territory Management (Aug. 2001). o PC-1; Professional Communication-1 (April 2001). SCOPE (Scientific office for promotion of AVENTIS products) o SSAW; Selling Skills Advanced Workshop (Oct. 2000). o SSTC; Selling Skills Training Course (July 2000). Continuing Education Clinical Research, Medical Writing & Data Management  John Hopkins University / Coursera, Design and Interpretation of Clinical Trials, Distinction (Feb. 2014 – March 2014).  Harvard University - Harvard School of Public Health, Harvard Medicine School /edX, HSPHHMS214x: Fundamentals of Clinical trials. Distinction (Nov. 2013 – Feb. 2014).  Rice University / Coursera, Nanotechnology: The Basics (Nov. 2013 – Dec. 2013).  Stanford University - School of Medicine, Writing in the Sciences (Sep. 2013 – Nov. 2013).  University of Texas Austin /edX – Take Your Medicine – The Impact of Drug Development, Distinction (Sep. 2013 – Nov. 2013).  Vanderbilt University / Coursera, Data Management for Clinical Research (Sep. 2013 – Oct. 2013).  Stanford University - School of Medicine / Coursera, Practical Tips to Improve Asian American Participation in Cancer Clinical trials, Distinction (Sep. 2013).  John Hopkins University - Bloomberg School of Public Health / Coursera, Vaccine Trials: Methods and Best Practices. Distinction (June 2013 – Aug. 2013).  University of California - San Diego Skaggs School of Pharmacy & Pharmaceutical Sciences / Coursera, Drug Discovery, Development & Commercialization, International Team Project: Life Cycle Strategic Plan Development, Distinction (April 2013 – July 2013).  Harvard University - Harvard School of Public Health /edX, PH207x: Health in Numbers: Quantitative Methods in Clinical & Public Health Research. Distinction (Nov. 2012 – Jan 2013). Biology  Ludwig-Maximilians-Universität München (LMU) / Coursera, Programmed Cell Death, Distinction (July 2013 – Aug. 2013).  MIT “Massachusetts Institute of Technology” / edX, Molecular Biology: The Secret of Life, (March 2013 – June 2013). Business Administration  Ludwig-Maximilians-Universität München (LMU) – Institute for Strategy, Technology & Organization / Coursera, Competitive Strategy, Distinction (July 2013 – Aug. 2013). Philosophy  Harvard University / edX, Political Philosophy: Justice, Distinction (March 2013 – July 2013).  Edinburgh University - School of Philosophy / Coursera, Introduction to Philosophy, Distinction (Jan. 2013 – Feb. 2013).  Duke University / Coursera, Logic & Philosophy: Think Again: How to Reason & Argue, Distinction (Nov. 2012 – Jan. 2013).
  • 8. Page 8 of 8 PARTICIPATION IN CONFERENCES & WORKSHOPS Conferences  Speaker in CRC Networking Day, “Clinical Research Overview in Egypt & MENA Region” (21 Feb. 2017)  Speaker in CVCT (Cardio-Vascular Clinical Trialists) International Conference, “Clinical Research Overview in Egypt & MENA Region” (22 Sep. 2017) GCP Workshops  Instructor in Armed Forces College of Medicine (AFCM) GCP Workshop (27, 28 Feb. 2017)  Instructor in National Research Center GCP Workshop (15 May 2017)  Instructor in TCD MENA GCP Workshop (9, 10 Oct 2017). PUBLICATIONS Esmat G et al. Effectiveness of ravidasvir plus sofosbuvir in interferon-naive and treated patients with chronic hepatitis C genotype-4. J Hepatol (2017), https://doi.org/10.1016/j.jhep.2017.09.006 LANGUAGES  Arabic: Mother language.  English: Bilingual proficiency.  French: Professional working proficiency. PERSONAL DATA  Date of Birth: July 1st 1978  Nationality: Egyptian  Address: 426 Gamal Abdel-Nasser St., Mandara, Alexandria, Egypt.  Marital Status: Single  Interests: Research, Internet Browsing, Movies, Readings: Strategy, Business, Medicine, Marketing, Philosophy, Psychology, History, and Novels.