Experience

ImmunogenX

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Chief Operating Officer

  • Feb 2016 - 7 years 11 months

  Newport Beach, CA



Renaissance Associates

• United States
• Financial Services
• 1 - 100 Employee

• Managing Director

  • Dec 2004 - 19 years 1 month

  Newport Beach, CA Founder and Managing Director of Renaissance Associates, a specialized full-service Contract Research Organization (CRO) providing integrated clinical research services to the biopharmaceutical and medical device/diagnostics industries. Responsible for all aspects of the day-to-day operations of the organization including, but not limited to: • Hiring, training and supervising employees. • Procuring business opportunities. • Managing individual clinical research projects… Show more Founder and Managing Director of Renaissance Associates, a specialized full-service Contract Research Organization (CRO) providing integrated clinical research services to the biopharmaceutical and medical device/diagnostics industries. Responsible for all aspects of the day-to-day operations of the organization including, but not limited to: • Hiring, training and supervising employees. • Procuring business opportunities. • Managing individual clinical research projects (line-level). • Business management activities (e.g., accounting and expense management, budget negotiations, etc.). • Procuring and negotiating with contractors and vendors to provide assistance with future/ongoing projects. Show less



Allergan

• Pharmaceutical Manufacturing
• 700 & Above Employee

• BOTOX® Medical Consultant (Professional Sales Consultant)

  • Jun 2002 - Jul 2004

  Orange, Los Angeles, San Bernardino and Riverside counties, CA (sales territory) Professional Sales Consultant for physician specialists and sub-specialists utilizing BOTOX® for therapeutic/medical applications. Represented BOTOX® in a variety of health-care settings including large teaching institutions (e.g., USC, Loma Linda University Medical Center), HMOs (e.g., Kaiser Permanente Medical Group), group practice and private practice. Provided consultative services for all approved clinical applications of BOTOX® as well as all reimbursement-related questions and… Show more Professional Sales Consultant for physician specialists and sub-specialists utilizing BOTOX® for therapeutic/medical applications. Represented BOTOX® in a variety of health-care settings including large teaching institutions (e.g., USC, Loma Linda University Medical Center), HMOs (e.g., Kaiser Permanente Medical Group), group practice and private practice. Provided consultative services for all approved clinical applications of BOTOX® as well as all reimbursement-related questions and problems. Select Achievements: • Leadership Council Award: 2003 • Region Salesperson of the Quarter (1st Quarter 2004) • 2002: Achieved 105% to plan (Top 20% of sales force) • 2003: Achieved 107% to plan (Top 15% of sales force) • Reversed decreasing annualized sales trend after first year in territory. • Conducted 38 medical education programs (CME, non-CME, etc.) over two-year period. • Scheduled, prepared and conducted more than 50 local reimbursement in-services over two-year period. • Selected as BOTOX® Medical Consultant representative to 2013 NSM Planning Team. • Selected as Southern California Kaiser Permanente representative (2002 and 2003).

• Product Manager (US BOTOX® Therapeutic Marketing)

  • Jun 2000 - Jun 2002

  Irvine, CA Product (Brand) Manager for BOTOX® Therapeutic in the United States. Responsible for market development activities including strategic marketing and tactical execution plan development. Select Achievements: • Created numerous CME, non-CME and CEU accredited medical education programs. • Managed MSL and sales professional activities when administering field-based programs. • Developed industry partnerships with for-profit and non-profit organizations to offer medical… Show more Product (Brand) Manager for BOTOX® Therapeutic in the United States. Responsible for market development activities including strategic marketing and tactical execution plan development. Select Achievements: • Created numerous CME, non-CME and CEU accredited medical education programs. • Managed MSL and sales professional activities when administering field-based programs. • Developed industry partnerships with for-profit and non-profit organizations to offer medical education for larger audiences. • Developed and conducted primary and secondary market research projects to gain a more thorough understanding of marketplace for neurotoxins in the United States. • Oversaw outside creative development and internal legal/regulatory review of promotional/branding programs. • Created and led BOTOX® Global Strategic Communications Team. • Responsible for increasingly larger marketing budget throughout tenure (20+% annualized budget growth). • Ensured adherence to marketing budget spending requirements (+/- 2%) during all budget cycles.

• Manager (Global Medical Marketing, BOTOX®)

  • Oct 1997 - Jun 2000

  Irvine, CA Responsible for review, approval and implementation of global post-approval clinical research studies for Allergan’s BOTOX® product. These studies included investigator-sponsored probe work (Physician INDs, IITs, etc.), pharmacoeconomics, quality of life, retrospective data analyses and comparative trials, etc. Select Achievements: • Managed global review team consisting of medical affairs, marketing, legal and regulatory personnel. • Collaborated with regional Product… Show more Responsible for review, approval and implementation of global post-approval clinical research studies for Allergan’s BOTOX® product. These studies included investigator-sponsored probe work (Physician INDs, IITs, etc.), pharmacoeconomics, quality of life, retrospective data analyses and comparative trials, etc. Select Achievements: • Managed global review team consisting of medical affairs, marketing, legal and regulatory personnel. • Collaborated with regional Product Managers in key markets to ensure study objectives were consistent with product positioning and promotional strategies for multiple product usages. • Served as the scientific liaison between Marketing/Sales and Clinical R&D to support clinical trials for the maximum benefit of the organization. • Collaborated with Product Managers, Regional Medical Directors and Field Sales Management to maximize the impact of promotional efforts and to develop KOL support for BOTOX® product. • Developed and maintained a customer focus that included collaborative working relationships with global KOL physicians to assist in guiding marketing, sales, business development and clinical programs, and to influence use of our product through peer-influence programs. • Departed position having responsibility for over 60 ongoing or pending clinical studies (based in US, Europe and Asia).

• Project Manager (Pharmaceutical R&D)

  • Oct 1995 - Oct 1997

  Irvine, CA Project Manager on four product development teams (Acular®, BOTOX® and two in-licensed clinical candidate compounds). Select Achievements: • Guided Acular® team towards completing four (4) supplemental NDA filings during a 13 month period. • Managed key activities and resources throughout global development cycle for these projects. • Planned and conducted monthly project team and subteam meetings to ensure progress of development efforts and tracked all ongoing action items… Show more Project Manager on four product development teams (Acular®, BOTOX® and two in-licensed clinical candidate compounds). Select Achievements: • Guided Acular® team towards completing four (4) supplemental NDA filings during a 13 month period. • Managed key activities and resources throughout global development cycle for these projects. • Planned and conducted monthly project team and subteam meetings to ensure progress of development efforts and tracked all ongoing action items to completion. • Responsible for determining and refining project development objectives, plans, schedules and costs with input from R&D line managers and project leaders. • Maintained regular communication with all levels of Allergan global management from a variety of departments (i.e., Marketing, Operations, Pharmaceutical Sciences, Clinical Sciences, etc.) to ensure that project activities and timelines continued to fulfill business objectives, requirements and priorities over each project’s life-cycle. • Determined budgetary requirements for assigned projects during the annual budget development process. • Went beyond job function by producing rough development plans, costs and timing for project candidates potentially transitioning to project status as well as for products or compounds being considered for acquisition, licensure, etc.

• Clinical Research Associate (Ophthalmology Clinical Research)

  • Apr 1993 - Oct 1995

  Irvine, CA Clinical Research Associate responsible for managing Phase 3 clinical trials in Ophthalmology Clinical Research department. Select Achievements: • Designed and developed Clinical Trial Outlines, protocols and final reports for scientifically valid human clinical trials. • Responsible for database creation/management, Case Report Form (CRF) development, and investigator brochure and informed consent form development. • Monitored 30 investigational sites in the USA and Canada… Show more Clinical Research Associate responsible for managing Phase 3 clinical trials in Ophthalmology Clinical Research department. Select Achievements: • Designed and developed Clinical Trial Outlines, protocols and final reports for scientifically valid human clinical trials. • Responsible for database creation/management, Case Report Form (CRF) development, and investigator brochure and informed consent form development. • Monitored 30 investigational sites in the USA and Canada throughout the course of two Phase 3 clinical trials for adherence to protocol design criteria and use of Good Clinical Research Practices (GCRPs) according to FDA regulations. • Negotiated individual site budgets and accountable for clinical study expenditures, payments and supplies. • Maintained an updated knowledge of recent developments in ocular as well as related clinical disciplines by attending classes, seminars and meetings and by reading current literature. • Specific clinical research experience involved nonsteroidal anti-inflammatory drugs (NSAIDs) for ocular use (i.e., Acular®, etc.).

• Formulation Chemist (Pharmaceutical Product Development)

  • Sep 1989 - Apr 1993

  Irvine, CA Formulation Chemist position in Pharmaceutical Product Development department responsible for developing prescription and OTC ophthalmic dosage forms. Chief formulation chemist for Refresh Plus® (previously Cellufresh®). Assistant formulations chemist for Ocuflox™, Pred Forte®, Pred-G®, Pred-Mild®, Celluvisc®, FML® and Refresh PM®. Select Achievements: • Planned, executed and formally reported results of laboratory experiments designed to create new prescription and… Show more Formulation Chemist position in Pharmaceutical Product Development department responsible for developing prescription and OTC ophthalmic dosage forms. Chief formulation chemist for Refresh Plus® (previously Cellufresh®). Assistant formulations chemist for Ocuflox™, Pred Forte®, Pred-G®, Pred-Mild®, Celluvisc®, FML® and Refresh PM®. Select Achievements: • Planned, executed and formally reported results of laboratory experiments designed to create new prescription and non-prescription (OTC) ophthalmic products. • Team leader at monthly team meetings with other groups within the company (Marketing, Regulatory Affairs, Pilot Manufacturing Operations, Package Development, Clinical Research, Toxicology Research, Microbiology, Pharmacology, Pharmacokinetics and Manufacturing) to further the product development process. • Responsible for suggesting, evaluating and developing new physical and chemical testing methodologies to aid in the formulation and analysis of new products. • Responsible for investigating and solving problems as they arose concerning raw materials, prefeasibility, in-lab stability, scale-up, production and analysis stages of product development.

• Laboratory Technician (Two positions: Associate & Senior)

  • Feb 1988 - Sep 1989

  Irvine, CA Bench chemist position within two pharmaceutical product development groups. Select Achievements: • Mastered formulation techniques for various ophthalmic dosage forms including solutions, suspensions, gels and ointments. • Mastered experimental techniques for analyzing the physical and chemical stability of potential ophthalmic products. • Attended pharmaceutical formulation training courses to augment job skills. • Responsible for scheduling and distributing… Show more Bench chemist position within two pharmaceutical product development groups. Select Achievements: • Mastered formulation techniques for various ophthalmic dosage forms including solutions, suspensions, gels and ointments. • Mastered experimental techniques for analyzing the physical and chemical stability of potential ophthalmic products. • Attended pharmaceutical formulation training courses to augment job skills. • Responsible for scheduling and distributing experimental contact lens care products for physical/chemical analyses. • Updated and maintained an active stability database for such products. • Went beyond job function(s) to perform physical/chemical tests to assist overburdened full-time chemists. • Responsible for developing a biochemical assay (SDS-PAGE) and data analysis methodology for human tear protein characterization and quantitation.