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30+ years of professional experience in the Pharmaceutical, Biopharmaceutical, and Medical Diagnostic industry. 25+ years of experience in clinical research, development, and clinical operations which includes, direct managerial responsibility for Clinical and Medical Operations Departments in US and Europe, direct managerial responsibility for clinical studies, project management of US and European clinical studies, management of clinical research personnel, and direct hands-on experience in the writing of IBs, protocols, CRF’s, statistical analysis plans, Clinical Study Reports, Orphan Drug Applications, IND’s, BLA’s/NDA’s, Type B and C Meeting Briefing Books, pre IDEs, and CE Mark applications. Direct management experience of a wide variety of multinational vendors and CRO’s. Has a proven record of successful, on budget and timely completion of clinical studies.
San Diego, CA, January 2015 – Present
A San Diego, CA start-up Biotechnology Company. Duties include strategic planning for the clinical development plan. Designing and executing in-vivo pre-clinical experiments in glioblastoma multiform and hepatocellular carcinoma. Also, responsible for correspondence with the FDA which includes Pre-IND Meeting requests, a Pre-IND briefing document and face to face Pre-IND meetings. Primary responsibilities include: Writing and managing an initial IND in glioblastoma multiform, CRO and vendor due diligence for a Phase 2/3 study in GBM, protocol development, Informed Consent development and selection of neuro-oncology centers/Investigators. Designed and authored numerous abstracts for the Society of Neuro-oncology Scientific Meetings, 2016-current. Also, is the primary corporate executive responsible for developing presentation materials for potential investors and corporate partners. This includes presentation at, and participation in, meetings with potential investors and corporate partners.
A mid-size San Diego, CA biotechnology company. Duties included interviewing executives, directors and project managers on the processes currently used for vendor selection. Also, SOP review on vendor selection, contract review of current vendors and a detailed gap risk management analysis. Presented findings and made recommendations. Implemented changes including rewriting and drafting new SOPs, detailed RFPs, metric tracking and CRO oversight procedures.
Including the responsibilities of Senior Director, I am directly responsible for the management of assembling numerous IND’s, CSRs, posting of study results to clinicaltrials.gov and running a dermatologic program for cellulite in Mexico. Also, responsible for the multidisciplinary assembly of sNDA and several FDA Type C meeting requests and briefing books.
Biosite Incorporated is a medical diagnostic company that specializes in the research and development of novel biomakers for rapid point of care (POC) diagnostic applications. Biosite was the first company to commercialize plasma B-type natriuretic peptide (BNP) to aid in the diagnosis and assessment of severity of congestive heart failure.
La Jolla Pharmaceutical Company (LJPC) specializes in the development of large molecules for the treatment of renal complications due to systemic lupus erythematosus (SLE).
I was directly responsible for the Clinical Operations and Medical Operations Departments in the conduct of an ongoing Phase 4 clinical study. Responsibilities include ongoing project management of a Contract Research Organization and hiring and training of new hires (contract and full-time), financial planning and forecasting.
Chugai Pharma USA (CPUSA) is the U.S. subsidiary of Tokyo-based Chugai Pharmaceutical Company Ltd. Both companies are a part of the Roche group.
A San Diego, CA start-up biotechnology company. Duties included position paper review and editing, strategic planning for venture capital funding, resource allocation to reach each milestone and general operations plans for company start-up.
Directly responsible for the writing and submission of all Regulatory documents to the FDA. Also, the Sponsor primary contact person for the FDA. Was directly responsible for the writing and oversight of a successful IND submission for Glioblastoma multiform. Wrote and submitted a successful Orphan Drug Designation dossier for hepatocellular carcinoma. Directly responsible for the planning and execution of Pre-Clinical <em>in-vitro</em> and <em>in-vivo</em> experiments in hepatocellular carcinoma, glioblastoma multiform, Huntington’s Disease, Alzheimer’s Disease and Breast Cancer Survivor Cognitive Impairment. Key stakeholder and decision maker on the cGMP manufacturing of API and Drug Product. Main contact for all Principal Investigator’s and consultants.
Halozyme Therapeutics is a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the diabetes, oncology, dermatology, and drug delivery markets.
Responsible for the day-to-day departmental clinical operations (including data management and biostatistics). This included budget development (both departmental and study related), direct managerial responsibility for up to 11 employees (CRAs, study managers, medical writers, Associate Directors), direct responsibility for successful completion of clinical studies in oncology, endocrinology and dermatology. Direct responsibility for departmental objectives that were on the corporate “balanced scorecard.” During this time reported to VPs and CEOs.
Directly responsible for the Clinical and Medical Affairs Departments located in the US and Europe. Responsibilities include financial planning and accounting of departmental and project expenses, resource planning and allocation, direct supervision of a Director of Scientific and Medical Affairs, Clinical Trial Managers, CRAs and CTAs. Project team leadership and participation in multinational and European medical device design and development and technical feasibility decision-making.
I was directly responsible for the Clinical Operations and Medical Operations Departments. Major responsibilities included hiring and training of new staff members, manpower resource allocation, development of operating budgets and financial forecasting, evaluation and selection of Contract Research Organizations in India, Asia-Pacific, and Eastern Europe and handling of investigator budgets and local country indemnity statements. Also, was directly responsible for the development and successful implementation of an operating plan that included growing Clinical and Medical Departments to handle a large multinational (US, Mexico, India, Asia-Pacific, and Eastern Europe) Phase 3 clinical study.
Directly responsible for the clinical development of a motilin agonist for GI motility disorders. This included all aspects of Phase 1 through Phase 3 development. Operational responsibilities include writing IND submissions, participation in meetings with the FDA, yearly budget allocation, head count projections, and strategic planning. Direct supervisor for the 11 Clinical Research Associates assigned to the project (2 in-house, 9 contract).
San Diego, CA, January 2015 – Present
A San Diego, CA start-up Biotechnology Company. Duties include strategic planning for the clinical development plan. Designing and executing in-vivo pre-clinical experiments in glioblastoma multiform and hepatocellular carcinoma. Also, responsible for correspondence with the FDA which includes Pre-IND Meeting requests, a Pre-IND briefing document and face to face Pre-IND meetings. Primary responsibilities include: Writing and managing an initial IND in glioblastoma multiform, CRO and vendor due diligence for a Phase 2/3 study in GBM, protocol development, Informed Consent development and selection of neuro-oncology centers/Investigators. Designed and authored numerous abstracts for the Society of Neuro-oncology Scientific Meetings, 2016-current. Also, is the primary corporate executive responsible for developing presentation materials for potential investors and corporate partners. This includes presentation at, and participation in, meetings with potential investors and corporate partners.
A mid-size San Diego, CA biotechnology company. Duties included interviewing executives, directors and project managers on the processes currently used for vendor selection. Also, SOP review on vendor selection, contract review of current vendors and a detailed gap risk management analysis. Presented findings and made recommendations. Implemented changes including rewriting and drafting new SOPs, detailed RFPs, metric tracking and CRO oversight procedures.
Including the responsibilities of Senior Director, I am directly responsible for the management of assembling numerous IND's, CSRs, posting of study results to clinicaltrials.gov and running a dermatologic program for cellulite in Mexico. Also, responsible for the multidisciplinary assembly of sNDA and several FDA Type C meeting requests and briefing books.
Biosite Incorporated is a medical diagnostic company that specializes in the research and development of novel biomakers for rapid point of care (POC) diagnostic applications. Biosite was the first company to commercialize plasma B-type natriuretic peptide (BNP) to aid in the diagnosis and assessment of severity of congestive heart failure.
La Jolla Pharmaceutical Company (LJPC) specializes in the development of large molecules for the treatment of renal complications due to systemic lupus erythematosus (SLE).
I was directly responsible for the Clinical Operations and Medical Operations Departments in the conduct of an ongoing Phase 4 clinical study. Responsibilities include ongoing project management of a Contract Research Organization and hiring and training of new hires (contract and full-time), financial planning and forecasting.
Chugai Pharma USA (CPUSA) is the U.S. subsidiary of Tokyo-based Chugai Pharmaceutical Company Ltd. Both companies are a part of the Roche group.
Directly responsible for the writing and submission of all Regulatory documents to the FDA. Also, the Sponsor primary contact person for the FDA. Was directly responsible for the writing and oversight of a successful IND submission for Glioblastoma multiform. Wrote and submitted a successful Orphan Drug Designation dossier for hepatocellular carcinoma. Directly responsible for the planning and execution of Pre-Clinical in-vitro and in-vivo experiments in hepatocellular carcinoma, glioblastoma multiform, Huntington’s Disease, Alzheimer’s Disease and Breast Cancer Survivor Cognitive Impairment. Key stakeholder and decision maker on the cGMP manufacturing of API and Drug Product. Main contact for all Principal Investigator’s and consultants.
A San Diego, CA start-up biotechnology company. Duties included position paper review and editing, strategic planning for venture capital funding, resource allocation to reach each milestone and general operations plans for company start-up.
Halozyme Therapeutics is a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the diabetes, oncology, dermatology, and drug delivery markets.
Responsible for the day-to-day departmental clinical operations (including data management and biostatistics). This included budget development (both departmental and study related), direct managerial responsibility for up to 11 employees (CRAs, study managers, medical writers, Associate Directors), direct responsibility for successful completion of clinical studies in oncology, endocrinology and dermatology. Direct responsibility for departmental objectives that were on the corporate “balanced scorecard.” During this time reported to VPs and CEOs.
Directly responsible for the Clinical and Medical Affairs Departments located in the US and Europe. Responsibilities include financial planning and accounting of departmental and project expenses, resource planning and allocation, direct supervision of a Director of Scientific and Medical Affairs, Clinical Trial Managers, CRAs and CTAs. Project team leadership and participation in multinational and European medical device design and development and technical feasibility decision-making.
I was directly responsible for the Clinical Operations and Medical Operations Departments. Major responsibilities included hiring and training of new staff members, manpower resource allocation, development of operating budgets and financial forecasting, evaluation and selection of Contract Research Organizations in India, Asia-Pacific, and Eastern Europe and handling of investigator budgets and local country indemnity statements. Also, was directly responsible for the development and successful implementation of an operating plan that included growing Clinical and Medical Departments to handle a large multinational (US, Mexico, India, Asia-Pacific, and Eastern Europe) Phase 3 clinical study.
Directly responsible for the clinical development of a motilin agonist for GI motility disorders. This included all aspects of Phase 1 through Phase 3 development. Operational responsibilities include writing IND submissions, participation in meetings with the FDA, yearly budget allocation, head count projections, and strategic planning. Direct supervisor for the 11 Clinical Research Associates assigned to the project (2 in-house, 9 contract).
Synergen was a start-up biopharmaceutical company located in Boulder, Co. Synergen was acquired by Amgen in December 2004 and was consolidated to form Amgen, Boulder.
Synergen was a start-up biopharmaceutical company located in Boulder, Co. Synergen was acquired by Amgen in December 2004 and was consolidated to form Amgen, Boulder.
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