JOSÉ FRANCISCO GÓMEZ VALERY

+**.***.***.**.**/+**.212.941.31.60

jf acfhaz@r.postjobfree.com /jf gomv acfhaz@r.postjobfree.com

/jf acfhaz@r.postjobfree.com/

PERSONAL PROFILE

I am a physician with internal medicine and gastroenterology specializations, bilingual (Spanish &

English), and with leadership experience in the Pharmaceutical Industry. I have a global vision

of the business at hand, targeted to get results, dev elopment of human resources, budget

management, skillful in the company’s decision making with high negotiation skills.

• •

Dev elopment of new businesses Training

Clinical trials Regulatory Affairs

• •

Pharmacovigilance New product s Launching

• •

Medical legal approval Public Affairs

• •

• •

Market Access Institutional Relationships

Sustainability/Social Responsibility Medical Compliance

• •

PROFESSIONAL EXPERIENCE

LA SANT É, INTERNAT IONAL PHARMACEUT ICAL GROUP 2013-

Medical Director

• Internal and external training

Sales representativ es

o

• Achievements: Optimization of resources through periodically online-training –

Thorough implementation of Moodle Program – all reps, and a 100% reduction

o Heaohexpenses.

ltf area:

General Practitioner

Pharmacy

Pharmacovigilance

• Strategic management from medical point of view in the business.

• Company’s spokeperson: active participation in radio & TV interviews related with

pathologies linked to portfolio’ products and nutrition & overweight, nationwide scope.

• Clinical Research

5 phase IV studies ongoing f ocused in digestive diseases, obesity and pain area.

o

Adjustment and creation of clinical protocols (Phase III and IV) to be submitted

o

before MOH, in order to increase involvement with MOH personnel and with the

new rules in clinical research. These protocols are shared with Latam countries,

“Best practice”.

• KOL management

o Participation and organization of scientific ev ents, adv isory boards and

round tables.

o Active participation in medical societies representing the company.

• Regulatory aff airs

o Supervision of activities those ensure approv al of new produc ts and line

extension in optimal time or in adv ance, and in consequence c ontribute with

anticipation of the launch times.

o Revision and approv al of the labeling’ inf ormation according technical

and regulatory polices.

J.F. Gomez Valery

SANOFI-AVENT IS DE VENEZUELA

2006-2013

Multinational Pharmaceutical Industry

Medical Director

• Product Support-Strategic Products

o Increase Medico-Marketing presence in create a plan/follow up f or all

strategic products.

o Superv ision and guarantee regulatory activities that contribute in new products and

line extension launches.

• Clinical trials

o Allocation necessary resources to clinical operations activ ities

o 6 publications perf ormed per year

o Superv ision of 18 ongoing multinational clinical trials

• Medical Affairs & Market access

o Focus on Product Patrimony Management

o Participation in projects with Gov ernment and KOLs

• Corporate Governance/Pharmacovigilance

o Guarantee all saf ety reports to be submitted to corporate & regulatory authorities

o Presentations in Simposia and different univ ersities at national lev el

• KOL Management

Budget Management

•

• Member of Adv isory Board against Drugs abuse

Member of Crisis Management team

•

Responsible f or Medical compliance at affiliate lev el

•

Spokesperson of the affiliate

•

• Social Responsibility Project (acting as affiliate’ corresponsal):

o Leishmaniasis

o Malaria

o Sustainability project, that inv olves actions in:

People

Patients

Ethics

Planet

• Direct Reports Management

o Between clinical operations, product patrimony management, medical

inf ormation and medical advisors, 10 people reported to me.

Achievements

• Dev elopment of new businesses

• Inclusion of new sites in inv estigation, which bef ore never participated, thorough

negotiation processes, with institutional heads.

• Leadership between Medical & Marketing in new launches processes.

• Medico legal approv al according corporate, CAVEME and local regulatory polices.

• Optimization & Increasing of personnel of Medical Department, guaranteeing

eff ectiv ely needs f rom internal & external clients.

• Improvement of organizational environment & increasing of motivation of human

resource, thorough the perf orming of meetings of inf ormation about f uture launches,

obtaining a f avorable impact in sales.

J.F. Gomez Valery

• Obtained more economical resources f or conducting clinical trials as possible, with

an investment approx . of almost 500 Keuros, in 2013.

• Reduction of selection time of potential investigators and guaranteeing more quality

in clinical trials, thorough an strict evaluation of physicians inv olv ed.

• Creation of Quality Manual, which collect all Standard Operations’ procedures of Medical

Department.

• Chairman of Medical Compliance committee and responsible of all aspects related

with corporate and local regulations

• Spokesperson at scientific level at the affiliate and attending interviews (newspapers, radio

& TV at national lev els) in scientifi c topis as:

o Medical treatment of isquemic cardiopathy

o Dengue

o AH1N1 pandemic situation

o Diabetes Mellitus

o Gastrointestinal disorders

MERCK SHARP & DOME DE VENEZUELA 2004-2006

Multinational Pharmaceutical Industry

Medical Director

• Medical advice in Commercialization area.

Training to internal customers (Sales representativ es) and external customers (Speakers).

•

• Responsibility in keep updated all the products of the company, and superv ision of

submissions of documents f or new and known product s bef ore the agency.

• Guarantee internal and external communication (Public & External Affairs).

Medical legal approval of all promotional material of the company.

•

Member of the Executive Committee.

•

• Participation in the selection of Venezuelan sites f or clinical trials.

Achievements

• Succeeded Management of COXIBS crisis bef ore Government & Media (Press release,

radio & TV).

• Interactiv e advisory to Marketing.

Leadership as spokeperson of the company.

•

• Outstanding certification as approv er in medico legal promotional materials, New

Jersey, USA.

AVENT IS DE VENEZUELA, Caracas, 2003-2004

Multinational Pharmaceutical Industry

Outsourcing Medical Advisor

Training to Sales Force. & revision of training manuals.

Speaker in presentations of company’ products oriented to Key Opinion Leaders, Phy sicians,

Paramedics personnel and patients.

PHARMACI A CORPORATION DE VENEZUELA, Caracas, 2000-2003

Multinational Pharmaceutical Industry

Medical Director

• Supervision and coordination of Marketing activ ities.

Clinical Studies coordination.

•

Training to sales f orce.

•

• Pharmacovigilance.

• Regulatory Affairs f inal responsibility.

Achievements

• Optimization of 100% of communication between Manuf acturing, Marketing & Medical

department, thorough creation of medico-marketing & new launches committees.

• Contribution of integration of human resource of the company oriented in motivates

whole health thorough inf ormative tips updated about health (‘Saludtips) thorough

electronic way.

• Reduction in 80% in execution time in activ ities of Medical department, optimizing corporate

Standard Operation Procedures, as well job descriptions.

• Optimization of a 100% in communication within the marketing, manuf acturing and the

medical department areas by creating the medical -marketing committees and the new

products committee

• 120% implementation on prev ious scheduled clinical study courses targeted to all

personnel involved in these activities improving in a 50% approv als f rom the regulatory

authorities, the enrollment of pati ents, procedures and the culmination of clinical studies

in record time.

• 30% increased in adv erse ev ents report on ethical products through the implementation of

inf ormative Pharmacov igilance meetings aimed at all company’s personnel.

• Inclusion of additional sites (health centers) that were not part of the clinical inv estigation

by negotiating with the institution.

• 50% greater product profitability by including them through negotiations in more clinical

studies than was previously planned f or Venezuela.

• Obtain greater economic resources f or clinical studies, an investment of approximately USD

1,700 MM in the last 6 years.

• Time minimization in selecting potential inv estigators, guaranteeing better quality studies

by the in-depth ev aluation of the doctors involved.

• Sales increment through systematic, interactive and constant training to the sales f orce.

• Prof essional dev elopment of clinical monitors, allowing f or investigators

personalized service which in returns brings better quality in clinical studies, main f actor in

the results obtained f rom the regulatory authorities such as FDA

PHARMACI A & UPJOHN, Caracas, 1997-2000

Multinational Pharmaceutical Industry

Medical Director

HOECHST MARION ROUSELL, Caracas, 1996-1997

Multinational Pharmaceutical Industry

Medical Advisor

HOECHST DE VENEZUELA, Caracas, 1993-1996

Multinational Pharmaceutical Industry

Medical Adv isor

FORMAL EDUCATION

Master in Gastroenterology

Hospital Dr. Domingo Luciani, UCV, Caracas, 1992

Master in Internal Medicine

Hospital Dr. Miguel Pérez Carreño/UCV, Caracas, 1990

Surgeon/Physician

Escuela Luis Razetti, UCV, Caracas, 1985

COURSES

Social Media Management, INCAE Business Schooll, Caracas, 2012

Media Training, Cambridge International Consulting, Caracas, 2009

Health economics course, Univ ersidad Central de Venezuela, Caracas, 2009

Diabetes Faculty Forum, sanof i-av entis, Barcelona, Spain, 2008

‘Presentation Fundamentals, Impactskills, Paris, 2008

Conflict Management, Consultores Gerenciales, Caracas, 2008

Basic Marketing Course, Sanof i-Aventis, Caracas, 2008

Management Dev elopment Program, Monteav ila University, Caracas, 2007

Rd

3 Intl Summit on Cardiometabolic Risk,World Heart Federation, Prague, Czech Republic 2007

II Congreso Internacional LES Comunidad Andina, Caracas, 2004

Practical Public Affairs W orkshop, Caracas, 2004

CANDEAN Medical Services Training, Miami Lakes, Florida, 2004

Decision Making Program, Merck & Co., Inc., 2004

EVENT S PARTICIPATION AS SPEAKER

Speaker in Pharmacovigilance, Jornadas de Actualización em Dermatologia Sanitaria, Margarita

Island, Venezuela, 2010

Coordinator in Ex pert Meeting of Actonel, Aruba, 2009

Inv estigator Meeting for clinical trial: Parecoxib in laparoscopic cholecistectomy, speaker in Good

Clinical Practices, Buenos Aires, Argentina, 2002.

Speaker and moderator in Parecoxib Regional Symposium about Parecoxib, (v enezuelan,

colombian and centroamerican’ physicians, Miami, Florida, 2002.

Symposium ‘End of Century Diseases', Scientific Association of Venezuelan

Journalism, Caracas, 1999.

Symposium ‘Overactiv e Bladder’, Venezuelan Urology Society, Caracas, 1999

Anniversary of Scientific events: Symposium: Staphylococcus aureus and medical-surgery update.

ACADEMICS

Prof essor of Pharmacology, Pharmacology School, Universidad Central de Venezuela, 2013

Teaching ex perience as pharmacov igilance instructor at Univ ersidad Central de

Venezuela, Univ ersidad Santa María and Univ ersidad de Carabobo.

AFFILIATIONS

Member of Physician’ College of D. F. # 10430 & Miranda State #11080.

Member of the American Society of Microbiology.

Member of Venezuelan Commerce & Industry Chamber

Member of Venezuelan Society of Internal

Medicine Member of Venezuelan Society of Gastroenterology

Member of Education committee of Venezuelan Society of Internal Medicine.

J.F. Gomez Valery

Member of AVEINFAR (Asociación Venezolana de Ejecutiv os de la Industria

Farmacéutica)

ACKNOWLEDMENT S

Nominated as an Executive of the Year, Medical Director, Aveinf ar, 2002.

Pharmacia-Latin-America CLINOPS Award, Brazil, 2003. Participation in

‘IV Consenso Venezolano de enf ermedad tromboembólica arterial y

venosa, 2008-09

PUBLICATIONS

‘Estudio de costo-ef ectiv idad de las terapias f armacológicas para el manejo de la hipertensión

arterial (HTA): Análisis económico de 3 ARA II en Venezuela’ (January to December 2009).

Casanov a, P. Gómez JF, Peña E, Gómez G. Dirección Médica, Sanof i-av entis de Venezuela,

S.A.

‘Estudio de costo-ef ectiv idad de las terapias f armacológicas para el manejo de la hi pertensión

arterial (HTA): Análisis económico de 3 ARA II en Venezuela’ January to June 2010). Gómez G,

Gómez JF. Dirección Médica, Sanofi-av entis de Venezuela, S.A.

‘Registro de ev aluación del tratamiento de cáncer gástrico (REGATE). Características basales,

diagnóstico y tratamiento y estadío de los pacientes ev aluados en Venezuela. Patricia

Arbelóa, Patricia Núñez, Lorena Lion, Zulay Pastrán, José Francisco Gómez, Gerber Gómez.

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