David Millard Email and Phone Number

Director oversight and leadership. 3 primary departments: Medical Writing, CRO contracts, budgeting vendor oversight, and Project Management group. Providing support for division, that includes test articles , lab notebooks, for PRECLINICAL (GLP): SOP writing, training and implemenattion, *Business Process Mnagement, CRO Management include cost efficiencies and KPIs, collaborate with QA for regulatory Compliance Role for US Anticorruption Laws and compliance training, Measure of compliace and… Show more Director oversight and leadership. 3 primary departments: Medical Writing, CRO contracts, budgeting vendor oversight, and Project Management group. Providing support for division, that includes test articles , lab notebooks, for PRECLINICAL (GLP): SOP writing, training and implemenattion, *Business Process Mnagement, CRO Management include cost efficiencies and KPIs, collaborate with QA for regulatory Compliance Role for US Anticorruption Laws and compliance training, Measure of compliace and support competency enhanced training where necessary, collaborate with stakeholders QA/QC and audit functions and negotiate duplicity between when it occurs.Reorganize dept for strategic fit with company goals, manage cost constraints, optimize processes and drive cost effective business economies of scale in all business operations Implemented innovative approach to maximize utility, value and strategic fit to sustain and provide a. leadership position to meet possible organization changes. Change mindset of staff from individual contributor to cross functional highly productive teams that are culturally competent, flexibility in rapid asset tactical team approach priorities, streamline and measure transition to proceed to optimization with team leader process line software/hardware approach.Process lead to focus on the entire process than a claimed portion to eliminate bottlenecks, possession claims and allow a more budget central budget contribution that is cost & resource effective yet remains flexible as regulatory, organization or standard models change. Liaisons *CDC,FDA,HOMELAND SECURITY, Special Regulatory Oversight for Homeland Security SBL4 Special Agent Restrictions SOPs, Archive US Fish & Wildlife, Ministries of Health. eek innovative partnerships to support FTE needs in times of cost constraints, prepare dept budget and capital forecasts per corporate goals. INCREASED DEPARTMENT PRODUCTIVITY in one year to 130% FOR ALL DELIVERABLES accomplishment Show less

CLINICAL (GCP GUIDELINES): Create, develop and lead multidisciplinary professionals as drug development teams taking investigational compound from concept ,clinical research Phase 1-4 trials, through NDA submission, marketing surveillance. Team members selected with expertise as Biostatisticians, medical /clinical leads, Clinical Project Managers, Genomics, Outcomes Research specialist, Clinical Database Managers, Genomics, Pharmacokinetics. Implement a process of continuous improvement… Show more CLINICAL (GCP GUIDELINES): Create, develop and lead multidisciplinary professionals as drug development teams taking investigational compound from concept ,clinical research Phase 1-4 trials, through NDA submission, marketing surveillance. Team members selected with expertise as Biostatisticians, medical /clinical leads, Clinical Project Managers, Genomics, Outcomes Research specialist, Clinical Database Managers, Genomics, Pharmacokinetics. Implement a process of continuous improvement strategy to drive team performance, accuracy. Drive team excellence with productivity and increased quality deliverables and expertise as a highly cohesive , cross functional , culturally competent global investigational Drug development team. Create strategic subject recruitment plans based upon real patient avaiability before placement aftr site assessment and feasibility reviews, rather than choose or re-use previous sites with the focus the attention to consider the economics of Lazarus effect or pareto distribution of (80/20) when planning study recruitment strategies. Organize and lead selection of external stakeholders to participate on Medical/Scientific Advisory Committees for protocol development & provide study familiar independent medical /scientific spokes persons for their constituents or regulatory management. Member BIOCOM, DIA, Chairman, Pfizer PAC (Political Action Committee, Pfizer Congressional liaison for California Congress Rep, and Senator, and Pfizer NYHQ Rep NAMI, Pharmacy Infectious Disease Specialist program developer, Pfizer rep Elton John Aids Foundation (2003’2007), Volunteer for Ralph Lauren Cancer Center, NY, DIA Session Chairperson for CME program, San Diego Medical Society Committee for Healthcare in Future, CME speaker for extern Physician and Medical groups, with diversified investigators and patients interested in Clinical Research, including DIA Program Session Chair for Incorporating Cliical Research in Commuinty Practices. , Show less

Roles:Clinical Program Operation Manager (CPOM)-Agouron Labs Accountable for clinical trial management in local initiated HIV protease Inhibitor post-marketing studies, Opthalmology and Optidrop Dose Delivery … Show more Roles:Clinical Program Operation Manager (CPOM)-Agouron Labs Accountable for clinical trial management in local initiated HIV protease Inhibitor post-marketing studies, Opthalmology and Optidrop Dose Delivery Device Trial for macular degeneration. , Nelfinivir) GAIN Study for HIV patients, C liincal Research Assoc. Show less

IMPLEMENT PFIZER NYHQ ASIAN CLINICAL RESEARCH IMPERATIVE EXPANDING INVESTIGATORS AND CLIICAL SITEV SELECTION FOR CENTERS OFV EXCELLENCE for planned focus for Asia lead. for Pfizer sponsored Clinical Trials Expansion from investigation site participation to leading Regional Area e.g. Therapeutic Clinical Trial Leadership for Oncology then all therapeutic area S. Korea, Japan, Taiwan, Hong Kong, Beijing from based in Pudong Shanghai Pfizer Center (German office area), focus on PLA sites(… Show more IMPLEMENT PFIZER NYHQ ASIAN CLINICAL RESEARCH IMPERATIVE EXPANDING INVESTIGATORS AND CLIICAL SITEV SELECTION FOR CENTERS OFV EXCELLENCE for planned focus for Asia lead. for Pfizer sponsored Clinical Trials Expansion from investigation site participation to leading Regional Area e.g. Therapeutic Clinical Trial Leadership for Oncology then all therapeutic area S. Korea, Japan, Taiwan, Hong Kong, Beijing from based in Pudong Shanghai Pfizer Center (German office area), focus on PLA sites( People Liberation Army) medical Centers Show less

OVERSIGHT OF MEDICAL AFFAIRS DEPARTMENT OPERATIONS FOR PHASE 4, POST APPROVAL MARKETING, SALES, INDEPENDENT INVESTIGATOR INITIATED RESEARCH, PATIENT ADVOCACY GROUP or AND EXTERNAL OTHER SCIENTIFIC LIAISONS, CLINICAL PHASE 4 STUDIES, INVESTIGATOR INITIATED RESEARCH GRANTS, CORPORATE MERGER DUE DILIGENCE EVALUATION AND SOURCE DOCUMENT AUTHENTICATION AND DATA VALIDATION ASSESSMENTS, ASSIMILATION IMPLEMENTATION STRATEGY.