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Mark Zorbas

Senior Research Scientist @ Agouron Pharmaceuticals, Inc

Senior Director at Pfizer

Greater San Diego Area

Ranked #1,093 out of 21,860 for Senior Research Scientist in United States

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Mark Zorbas's Email Addresses & Phone Numbers

Mark Zorbas's Work Experience

Agouron Pharmaceuticals, Inc

Senior Research Scientist

January 1996 to January 1999

Agouron

Senior Scientist

1994 to 1999

2003-2006

Senior Director, Safety Testing and Evaluation, Safety Sciences La Jolla (department name change)

Mark Zorbas's Education

University of Arkansas for Medical Sciences, College of Medicine

Doctor of Philosophy (PhD), Pharmacology and Toxicology

1985 to 1990

UC Davis

BS, Toxicology

1978 to 1983

University of California at Davis

B.S, Toxicology

1978 to 1983

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Mark Zorbas's Estimated Salary Range

About Mark Zorbas's Current Company

Agouron Pharmaceuticals, Inc

Frequently Asked Questions about Mark Zorbas

What company does Mark Zorbas work for?

Mark Zorbas works for Agouron Pharmaceuticals, Inc


What is Mark Zorbas's role at Agouron Pharmaceuticals, Inc?

Mark Zorbas is Senior Research Scientist


What is Mark Zorbas's personal email address?

Mark Zorbas's personal email address is ma****[email protected]


What is Mark Zorbas's business email address?

Mark Zorbas's business email address is m****[email protected]


What is Mark Zorbas's Phone Number?

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What industry does Mark Zorbas work in?

Mark Zorbas works in the Pharmaceuticals industry.


About Mark Zorbas

📖 Summary

Senior Research Scientist @ Agouron Pharmaceuticals, Inc From January 1996 to January 1999 (3 years 1 month) Senior Scientist @ Agouron From 1994 to 1999 (5 years) Senior Director, Safety Testing and Evaluation, Safety Sciences La Jolla (department name change) @ 2003-2006 My primary duty is the management a group of senior scientists who support the nonclinical safety from late discovery through loss of exclusivity In four therapeutic areas: Oncology, Ophthalmology, Antivirals and Diabetes/Obesity. The local portfolio comprises 22 compounds in early and late stage development. My other key responsibility includes the oversight of In vivo GLP safety studies conducted In La Jolla (1 study director [DVM/PhD], a study technician supervisor and 5 animal technicians). Other duties include La Jolla representative to Worldwide Advance Development Network Management Team (ADNMT) for centralized conduct of long-term safety studies, La Jolla team leader for scheduling and prioritizing conduct of GLP pre-FIH studies with PGRD Ann Arbor Safety Sciences and Safety Sciences representative to the La Jolla early development portfolio governance team (Drug Council Senior Director @ Pfizer, Inc. I manage the regulatory submission group within Drug Safety at the San Diego facility Study Director @ Bayer Corporate Toxicology Lead study conduct group in short-term toxicology studies From 1992 to 1994 (2 years) Medical student tutor @ UAMS From January 1987 to January 1988 (1 year 1 month) Senior Director @ Pfizer Therapeutic Area Leader (TAL) for Ophthalmology and Dermatology and Regulatory Strategy and Compliance Site Lead-La Jolla. As TAL, responsible for program safety testing strategy and nonclinical safety risk management for all compounds within assigned TAs from early discovery to LOE. Dotted-line responsibility for performance of Drug Safety Team Leads (DSTLs) and understanding of safety-related competitive landscape for disease targets and compounds within assigned TAs. See other regulatory strategy duties immediately below. DSRD sponsor for Pfizer one voice (POV) on pending ICH S6 guidance maintenance and re-evaluation of ICH recommendations for non-rodent chronic toxicity duration and former leader and current member of DSRD Biotherapeutics team. Represent DSRD as the team lead for a monoclonal antibody program for the indication of relief of signs and symptoms of chronic pain. Drug Safety team lead on vaccine program for Alzheimer's Disease. Senior Director @ Pfizer People manager, nonclinical global regulatory submission (IND/CTA; NDA/BLA, etc.) preparation oversight for products in Oncology, Pain, Diabetes, CVMed, Neuro. Expert advice and consult for nonclinical testing strategies in same therapeutic areas Senior Director @ Pfizer I am Senior Director. La Jolla site lead for Regulatory Strategy and Compliance; Drug Safety Therapeutic Area Lead for Ophthalmology Acting DSE site leader @ Pfizer Additional responsibilities as site leader included management of department resources consisting of approximately 20 personnel (6 Ph.D./DVM), recruitment of an additional 8 headcount and a 15 million dollar annual budget, DSE La Jolla representative on DSE executive team and La Jolla site leadership team. Senior Director @ Pfizer Therapeutic Area Leader (TAL) for Ophthalmology and Regulatory Strategy and Compliance Site Lead-La Jolla (Pfizer Re-organization and name change of line to Drug Safety R&D [DSRD]). As TAL, responsible for program safety testing strategy and nonclinical safety risk management for all compounds within assigned TAs from early discovery to LOE. Dotted-line responsibility for performance of Drug Safety Team Leads (DSTLs) and understanding of safety-related competitive landscape for disease targets and compounds within assigned TAs. Represent DSRD as the team lead for a monoclonal antibody program for the indication of relief of signs and symptoms of chronic pain. Senior Director, Development and Regulatory Strategy Site Lead - La Jolla. My primary duties include:Develop and implement strategy to influence regulatory environmentManage a group ( 3 senior PhDs; 1 MS and 2 BS) responsible for pre-IND-LOE authorship of the toxicology and safety pharmacology contributions, integration of all nonclinical contributions, oversight of the timeline for delivery of the nonclinical sections including document reviews and QC, responsibility for the format and compliance of the dossier to international standards and delivery of submission-ready module 4 components and program-based regulatory strategyProvide input to project planning for J-IND and J-NDA; assure that local dossiers are reviewed for eventual acceptance of the toxicology package in JapanResponsible for group which provides support to DSTLs for regulatory meetings and submissions, conducts QC review of regulatory submissions and study reports, provides document management support for regulatory submissions, facilitates preparation and review of correspondence with worldwide regulatory agencies including regulatory queries within DSRD. Assistant Director @ Pfizer Safety Testing and Evaluation, Drug Safety Evaluation (DSE), Pfizer Global R&D-La Jolla. Primary responsibilities include oversight of the La Jolla portfolio non-clinical drug safety testing strategies and risk management for 12 development candidates, La Jolla representative to Pfizer DSE steering committees including protocol harmonization, insourcing/outsourcing and workload sharing. La Jolla representative to global DSE for pre-ED and FD reviews and Confidence in Safety (CIS) scoring model Implementation and roll Senior Scientist II, Manager @ Drug Safety Evaluation Duties continued as those listed below. Also, current integration responsibilities for the "new" Pfizer:Co-Chair of DSE Integration Insourcing/Outsourcing subteamMember of DSE Integration Workload Sharing Resource Capacity SubteamMember of DSE Integration Cost Savings/Budget SubteamMember of DSE Integration Protocol Harmonization SubteamFacilitator for DSE Integration Discovery Support/Lead Optimization Subteam From January 2000 to January 2001 (1 year 1 month) Senior Scientist II, Manager @ Agouron Pharmaceuticals, Inc Duties include: Direct supervision of two associates. My primary job functions are: (in addition to those described below for Research Scientist) Core project team member for four antiviral and one anticancer targets.Budgetary responsibility for project-related Toxicology studies.La Jolla site representative for Global DSE budget.Develop and maintain preferred outsource Toxicology contract vendors.Prepare Toxicology section for IBs, INDs, Annual Updates, NDAs and product label on responsible portfolios. From January 1999 to January 2000 (1 year 1 month) Research Scientist @ Agouron Pharmaceuticals, Inc Duties include: Direct supervision of one associate. My primary job functions are as follows:Prepare and execute drug safety (Toxicology) development plan (studies and timeline) for responsible portfolios.Design protocols for acute, subchronic, chronic, carcinogenicity, development and reproductive toxicology studies to comply with ICH guidelines when applicable.Oversee the placement, monitoring and scientific evaluation of contract toxicology studies in the US and abroad.Interact with regulatory agencies on portfolio-related issuesProvide guidance on toxicologically-related issues for product discovery, manufacturing and pharmaceutical development groups in-house.Support and update MSDS toxicology information related to Agouron products.Oversee EU New Chemical Notification for manufacturing intermediates From January 1994 to January 1996 (2 years 1 month) Study Director @ Miles Inc include: Direct supervision of two technicians (both possessing B.S. degree). My primary job duty was the design and conduct of short-term toxicity studies to comply with the Good Laboratory Practice standards set forth by USEPA-FIFRA (40 CFR part 160), USEPA-TSCA (40 CFR part 792) and OECD 1981. A second aspect of my job duties was to review toxicology study reports received in-house to determine whether results were reportable under "adverse effects" or "significant risks" clauses of TSCA, FIFRA or FDA. Additional job duties include HAZLAB coordinator for Toxicology and product steward for selected products regarding toxicology inquiries from internal or external (regulatory agencies) customers.CONTINUING EDUCATION5/02 DIA: Risk Management Comes of Age From January 1992 to January 1994 (2 years 1 month)


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In a nutshell

Mark Zorbas's Personality Type

Extraversion (E), Intuition (N), Feeling (F), Judging (J)

Average Tenure

2 year(s), 2 month(s)

Mark Zorbas's Willingness to Change Jobs

Unlikely

Likely

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