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Click here or scroll down to respond to this candidateCandidate's Name , Pharm.D., MBAStreet Address
Home: PHONE NUMBER AVAILABLE Cell: PHONE NUMBER AVAILABLE Email: EMAIL AVAILABLEPROFILE SUMMARYExperienced Pharmaceutical Industry Executive with 20+ years of global pharmaceutical, biotech, hospital and community pharmacy experience with proven track records of leadership, collaborative partnerships in and driving cross functional oncology, cardiovascular, stroke, diabetes, CNS, pain management, anti-infective, immunology, HIV, epilepsy & products global labelling, promotion and development. Comprehensive background in clinical research (phases I through IV), clinical operations, project management, medical affairs, regulatory, business development, supply chain and distribution and health care investigative activites.More than 15 years of outstanding supervisory experience and highly effective in collaborative partnering to achieve strategic, tactical and operational organizational goals; worked in various positions in clinical trials, including CRO experience with focus on in-patient hospital and outpatient clinical research with excellent knowledge/understanding of risk mitigation in clinical research.Analyzed & interpreted scientific clinical data in collaboration with opinon leaders, clinical trial investigators, marketing drug advertisement and regulatory risk management, development and execution of a comprehensive global strategic medical marketing communications, standard response documents (SRDs), backgrounders, products launch materials across global and US markets. corrected loopholes in clinical trials and marketing strategies in compliance with various regulations, clients policies and procedures.Developed & updated global & local markets integrated medical communications with new clinical trial data in the creation of marketing programs, publications, clinical data results presentations, update of product safety reports and treatment guidelines. Experienced in pricing, contracts, integrated clinical trials with marketing strategies within pharmaceutical and healthcare industries. Years of hands-on experience with data query and analysis. acted as internal subject matter expert on specific in-house data sources, including but not limited to Medicare & Medicaid.Managed contractor strategy, portfolio and operations for established products within the North East of the United States of America business development in collaboration with the Seniordirector, strategy, portfolio and operations in executing of strategies in support of the establishedproducts business objectives.Demonstrated ability to apply problem-solving skills across complex issues to execute against the strategic vision; demonstrated excellent leadership and social skills with a heightened ability to collaborate and work within a matrixed team. Worked with leadership to create strategic objectives that met business needs and proactively led cross-matrix teams in achieving objectives.Excellent project management skills with the ability to prioritize activities to meet and exceed project expectations; ability to organize, integrate and analyze complex data sources to produce cohesive insights that informed continuous program experience improvements and brand decisions on patient access, assessing regulatory risks in drug labeling & sales and marketing promotion activities.PROFESSIONAL EXPERIENCEPharmacy ManagerWestchester Avenue Pharmacy, Bronx NY 01/2013 03/2023Supported integrated local market access and expansion strategy for different product lines and portfolios in collaboration with various healthcare systems in drug formulary review and acceptance of bundled product market strategies for a cost-effective pricing formular and provision of value-added services to support preferred client status. Worked exclusively with marketing, opinion leaders and medical affairs teams in developing pricing and value-added services and trained sales force for targeted competitive market segments that achieved specified market share in selected therapeutic areas with great emphasis in being competitive in drug labeling and promotion activities within FDA guidelines and industry standard with investigative activities to ensure compliance in all functions.Provided leadership of setting and implementation of the operational strategy for delivery of one or more sophisticated programs in Clinical Trial Management (CTM) including decisions on quality, timelines, budgets related to the conduct of clinical research studies in accordance with applicable regulations (ICH/GCP) and company Standard Operating Procedures (SOPs) to meet all regulatory requirements and risk management.Accounted for the overall success of the clinical study teams through pro-activity and effective communication with all stakeholders within programs through direction, implementation and provision of overall management. Identified and developed business relationships with key customers, state and local advocacy groups, prescribers, and managed care organizations, payers/ public and private insurance.Managed a portfolio of projects, programs, and processes associated with cardiovascular, CNS andinfectious diseases for the North East of the United States business segments in collaboration with the business, product, finance, development, and implementation leaders and stakeholders to accurately reflect all project work at every lifecycle stage within the portfolio for forecasting, analysis, delivery, and business decision making.Provided support of centralized and decentralized medication-use systems, medication therapy management, delivered optimal medication therapy to patients with a broad range of disease states Delivered hands-on patient care, Insurance, ensured compliance with controlled substance regulations, and general customer service. Ordered, Prepared, Distributed, Dispensed prescription medications to customers, consulted with physicians and patients, performed administration duties, supervised and oversaw pharmacy and administrative staff, advised patients on drug and other health-related topics.Director of Pharmaceutical Care Services (contract assignment)Womens and Childrens Hospital, Lafayette LA 2/2012 11/2012Directed and managed organizational medication management and clinical research; expanded contemporary pharmacy practice and clinical research to include cardiovascular and CNS conditions; contributed to patient care through integrated Clinical Services and Training that ensured successful on-going pharmacy clinical programs and clinical research as a new source of generating revenue.Provided scientific and medical supervision for phase 3 and 4 studies, authored and co-authored extended synopsis, clinical sections of protocols, eCRFs and data collections tools, and provided leadership to internal Clinical Trial team, medical review of data, prepared training materials for monitoring team and Investigators meeting, provided training to internal study teams and Medical Advisors. Collaborated with the sponsors Global Development Operations, Medical and Regulatory Affairs Leads on content for clinical sections of Agency briefing packages and ensured the successful strategy, tactical and operational execution of the clinical program and protocols and for product labelling for increased market competitiveness at minimal risks & also meeting FDA regulations.Provided advice on the clinical aspects of regulatory strategy in support of the filing of INDs and CTAs and license applications; led and contributed to the preparation of clinical sections for regulatory meetings and attended and presented at such meetings (e.g., pre-IND or end Phase II meetings/ Scientific Advice/ Advisory Boards).Associate Director, Drug Supply OperationsMorphotek Biopharmaceuticals, Eaton PA (subsidiary Eisai Pharmaceuticals) 2/2010 01/2012Directed the strategic, tactical and operational direction and execution of global drug supplies development programs including management responsibility for internal Clinical Operations staff, external contract organizations, and external stakeholders. Directed medical and pharmacy drug labeling and promotion to enhance competitiveness by monitoring by competitive intelligence gathering on competitors labeling, promotions and their management of FDA issues.Directed and managed multiple projects and teams on study designs, execution and management from protocol designs, issue identification, through research and analysis portion of Clinical Operations and contribution to the clinical operations strategy. Supported and supervised the selection, oversight, and management of CROs and other vendors, clinical sites selection, coordinated with finance and project management on budgets and study timelines; provided guidance to cross functional project team on complex issues, status updates, forecast potential project shortfalls.Authored and contributed to the development and review of several therapeutic clinical studies and regulatory documents including Study protocols, IB, ICFs, Biomarker, Data Monitoring and Management, Safety, Data Quality, ePRO, Imaging, Endpoint Plans, SAP, IND and NDA submissions. Led periodic review of clinical trial data for data integrity, data trends, and analysis for Interim and Final reports and updates to global Regulatory Agencies for all oncology programs. Led and contributed to the development of the oncology advocacy and policy strategies and execution of ovarian and non-small cell lung cancers advocacy and policy plans.Directed implementation of an effective pharmacy compliance program for the preparation and dispensing of investigational intravenous infusion drugs, provided guidance and support in accordance with global Regulatory Agencies requirements. Established, directed and monitored medical and pharmacy drug pipeline competitive intelligence processes, monitored drugs in development and new drug approvals. Led internal team of clinical pharmacists and financial analysts as internal subject matter expert in oncology therapeutic drugs and emerging therapeutics, including financial forecasts, and provided key metrics and drug pipeline impacts that drove internal efficiencies, changing priorities, budgetary allocations and hospital investigative activities to ensure compliance.Contributed to study data analysis, interpretation and study reports, scientific publications and presentations; clinical component of the global submission dossier and provided scientific defense of the clinical components of the submission dossier and ensured that all development activities are targeted towards timely achievement through collaboration with key interfaces within and outside the division.Provided oversight and review within legacy clinical development information Systems; partnered with internal staff to ensure CRO study documentation is in compliance with established standardized practices for study document review, support for regulatory agencies (RA) submissions and final document disposition. Planed, tracked, and managed all aspects of the trial(s), including the financial aspect, pivotal regulatory trials and potentially Investigator Initiated Trials and marketing trials in collaboration with clinical development partners and managed all resources (FTE, budget, etc.) to ensure successful completion.Global Director US Government on Global Health InitiativesIn collaboration with WHO and Pharmaceutical Alliance (contract assignment) 1/2008 01/2010Directed Drug Safety and Pharmacovigilance (PV) for marketed products, enhanced clinical research capability development in the sub-region, and managed phase 3-4 clinical research studies. Led the creation of the Global Pharmacovigilance and Clinical Drug Safety groups strategy, goals and objective, resources, budgets and maintained the highest level of quality and regulatory compliance.Accountable for assessment of performance of pharmacovigilance group against Clinical Drug Safety processes (SOPs), standards and performance goals, and ensured successful completion of all required training to global standards. Provided oversight of the global pharmacovigilance system (outsourced to CRO); collaboratedwith Quality Compliance and Clinical Science/Regulatory departments that ensured PV and clinical drug safety SOP and procedures are in place and reviewed and updated as necessary to ensure compliance with global pharmacovigilance requirements.Oversaw CRO and Partners performance on database management, reporting safety trends, reporting SAEs and AEs of Special Interest appropriate marketed products.Ensured implementation of local and global safety strategy including maintaining awareness of new and emerging safety concerns and related communication to competent authorities in a time frame appropriate to the benefit-risk assessment in the applicable areas.Provided input into responses to inquiries from regulatory authorities or health care professionals on drug safety issues; Participated in the development of and updating of safety information to the core data sheet, the investigators brochure (IB), label, risk management plan and other safety documents for products; supported and managed quarterly Executive Safety Review Committee meetings, coordinated post marketing surveillance and pharmacovigilance activities.Collaborated with Regulatory, Medical Affairs, Marketing, Clinical Operations, Drug Supply, Clinical Science personnel provide expertise and guidance to personnel regarding good pharmacovigilance and clinical drug safety practices. Interacted with Partners, CROs, vendors PV groups and addressed safety queries, shared best practices, and new safety regulations.Supported Sponsors Clinical Operations, Regulatory Affairs and CROs on Data Safety Monitory Committee meetings. Assisted Regulatory and Clinical Operations with filing SUSARs, DSURs, and other periodic reports and required responses to Regulatory authorities, and IRBs in compliance with GCP and regulatory guidelines.Ddirected the conduct of assigned global Phase III and IV registration trials, managed the clinical trial team and delegated task packages to team members, ensured appropriate CRO surveillance and management of other third-party vendors; supervised training programs to assure consistency and compliance in monitoring of clinical trials; prepared and distributed ad hoc reports for senior managementManaged medical/clinical research information functions for data collection on CNS, cardiovascular and HIV/AIDS for clinical research capability development; identified and executed projects that substantially determined and contributed to the continuum of product development; defined, analysed and synthesized commercial input into clinical strategy including study design, data analysis, and study results interpretation.Director of Pharmaceutical Care Services and Clinical ResearchSempercare, Belleville NJ /St. Marys Medical Center, Huntington, WV 2/2004 12/2007 (contract assignment)Directed the implementation and integration of hospital-wide standardization, utilization, integration, and optimization activities for sponsored phases IV clinical research capabilities across continuum of protocol evaluation, local IRBs reviews management, data capture, documentation, in compliance with FDA and ICH-GCP guidelines including meeting sponsors expectations and hospital goals to compete and participation in sponsored clinical research.Directed clinical research development programs and operations across all functional departments including translation of establishment of strategic development designs to local requirements, regulatory submissions, allocation of in-house resources, site budgets and trained staff; prepared recruitment and retention, and monitoring plans for the execution of clinical research trials, Supplies, monitoring, data collection and analysis and quality assurance oversight.Participated, as Subject Matter Expert to Sponsors in designing sponsored phase III and IV clinical development strategy, ensured integration across internal medical and scientific expertise, and Regional Network sites. Managed in-house adherence to good clinical practices (ICH-GCPs), good laboratory practices (GLPs) and ICH PhRMA and CFR guidelines, companys policies, SOPs and work instructions with ongoing training to compliance.Served and contributed, as external consultants, to the preparation of clinical sections for regulatory meetings, attended and presented at such meetings including pre-IND or end Phase II meetings/ Scientific Advice/ Advisory Boards.Director, Pharmacy and Pharmaceutical Care Services (contract assignment)East Orange (NJ), General Hospital, Olean NY 1/2001 1/ 2004Directed the pharmaceutical care services for the 375-bed acute care hospital and establish clinical research capabilities throughout the hospital by collaborating with the appropriate investigators to ensure compliance with FDA/ICH-GCP regulations and guidelines including achieving hospital specified goals.Developed integrated strategies with Sponsors that established hospital-wide clinical research standard operating procedures for monitoring; data quality, integrity of safety and efficacy data; Contributed, as Clinical Research Consultants on Advisory Boards, on development of promotional materials, and drug cost analysis, annual safety reports. Supported implemented regulatory strategies for product commercialization (trial design, product labelling, reimbursement, managed care drug formulary, and department of defence contracts.Provided hands-on support in all phases of clinical trial, protocol development and training of internal and external personnel, medical monitoring and quality control. Provided advice on the clinical aspects of regulatory strategy in support of INDs and CTAs and license applications filings; led and contributed to the preparation of clinical sections for regulatory meetings and attended and presented at pre-IND and Phase II meetings/ Scientific Advice/ Advisory Boards.Managed the adherence to all relevant regulations including ICH, PhRMA and CFR guidelines, companys policies, SOPs and work instructions with ongoing training in compliance and acquiring therapeutic specific knowledge in order to maintain a solid knowledge base for performing assigned tasks.Project Director,OmniCare Clinical Research, King of Prussia, PA 12/2000 12/2001Directed and managed multiple projects working with project delivery team on project design and execution including conception, issue identification, hypothesis formation including contribution to clinical operations strategy and led accountability for execution, management, selection of clinical sites, coordination with finance and global project management; provided explanations and information to project team on complex issues, status updates; forecast potential project shortfalls and escalate as appropriate.Directed global phases II to IV clinical research and medical activities in cardiovascular, CNS, and oncology coordinated all project team meetings, tracked all timelines and associated budgets developed objectives for project teams for product and program development and strategies for portfolio management including building and leading multidisciplinary project teams to ensure that clients studies were completed on time, within budget, and in compliance with SOPs, FDA/MEA regulations, and ICH-GCP guidelines and 15% improvement in client retention.Contributed scientific and medical expertise and led the preparation, review and submission of clinical program documents (including investigator brochure/IMPD, IND/CTA annual reports, Health Authority briefing books and submissions (NDA, MA, NDS etc.), and support product labelling teams.Prepared periodic reports, tracked contracts, processed payments to investigators in a timely manner; assisted in organizing in-house and off-site investigator meetings and training; identified product offerings, market positioning, licensing, and pricing strategies that were consistent with regulatory requirements and managed more than 40 CRAs and supervised more than 50 subordinates.Directed and managed investigator meetings and other third-party vendors involved in planning and execution of the clinical trial(s) with interaction with IRBs and regulatory authorities in close collaboration with the companys Regulatory Affairs department.Led the clinical team to develop global clinical strategy and incorporate strategy into the CDP with regular updates as appropriate and ensured alignment across regions and lines through the clinical team in executing Global CDP and collaborated with Global Team Leader to align CDP with GDP and updates across functional leadership.Served as an internal clinical therapeutic expert developing and maintaining an understanding of key disease states/etiology, treatments, therapeutic trends, competitive agents for the indications and development projects in therapeutic area; actively participated in Commercial Development activities by contributing to publication planning, Clinical Communication, reviewed Global Business Teams activities to ensure close collaboration with Sponsors Medical Affairs.Directed clinical development of project planning, protocol concept development and clinical trial design, generation of study synopses, and assessment of clinical study results; provided medical review for study relevant documents such as protocols, clinical study reports, Investigator Brochures and review study specific plans, data coding conventions and data reconciliation procedures, statistical analysis plans and informed consent documents, and provided review of final study reports.Prepared, participated and organized meetings (such as Investigators meetings, Steering Committees, Safety and Adjudication Committee); developed strong relationships and interacted with Medical Advisors from the Clinical Study Units in the regions, Physicians from the Strategic Units and Representatives from the Pharmacovigilance and Data Management groups.Director, Clinical ResearchBracco Diagnostics, Princeton, NJ 12/1997 12/2000Provided overall creative and strategic leadership for development and regulatory strategy core leadership team, worked and partnered with cross functional departments and internal stakeholders. Led definition of overall creative strategy and direction for evidence-based imaging agents procedures, companion diagnostics, and devices for diagnostics imaging practices and protocols.Created and managed a 5-year product development portfolio execution from preclinical, clinical and regulatory reviews roadmaps in alignment with company goals and objectives. Led cross-functional project development teams and facilitated regional and global clinical development for oncology and cardiovascular contributions including the identification and evaluation of clinical scientific issues, interpreted clinical data and contributed to clinical study reports, participated in global clinical development meetings, contributed to harmonized protocol designs, present clinical data during internal and external meetings; provided scientific expertise for clinical development including cross-functional collaboration and oversight for all clinical scientific aspects of registration trials.Directed clinical trials strategic development, designed, timelines, budget, and resources that achieved program objectives, corporate milestones, improved regulatory submissions and commercialization. Designed clinical trials and contributed to the integration of clinical and regulatory strategy into overall development plan; project scope, budgets, tracked and managed progress, issues and constraints, coordinated preparation and finalization for clinical study reports and publications.Managed protocol writing, clinical trial operations, and coordinated activities with the global clinical project team; mentored project teams on earned value analysis methodology and project management principles and generated progress and resource reports. Managed strategic and tactical product licensing, market conditions, and developed streamlined marketing and external events and their impacts that leveraged increased product-licensing evaluation and market share.Designed an integrated clinical research development and commercialization strategy, which reduced studies completion timelines, improved radiology diagnostic services, increased working relationships with investigators and thought leaders. Contributed to the development of Clinical Scientists through active participation in training and mentoring activities in study design, conduct, generate clinical study reports, and file to regulatory agencies Clinical trials of products development.Organized and managed investigator meetings according to regulatory requirements and managed Clinical Research Organizations (CROs) and third-party vendors, managed interaction and responses to IRBs and regulatory authorities in close collaboration with the companys Regulatory Affairs department.Manager Medical Marketing and Outcome ResearchBristol-Myers Squibb, Plainsboro, NJ 3/1991-11/1997Supported and drove the Global HEOR and RWE strategies, built tactical plans and managed asset team in the execution of the market access and medical communication strategy and evidence generation activities engaged and provided strategic and tactical directions to the Clinical, Medical Affairs, Global Project Teams (GPTs) and Global Brand Teams (GBTs) and commercial organization and drove product evidence strategies that ensured effective use of HEOR and RWE methods, product development plans, clinical development plans, and commercialization plans.Directed cross-functional collaboration between Global Value Access and Pricing, Medical Communications and other internal stakeholders including R&D. Supervised the conduct of HEOR and RWE projects including early economic models, burden of illness studies, external control arms to support single arm trials, and drive the development, analysis, and validation of patient-reported outcome (PRO) instruments in clinical trials Proposed and drove the implementation of analysis of clinical trial data for cost effectiveness; Led assessments of RWE data gaps and building cross-functional evidence generation strategy for payers and reimbursement submissionsLed the team in the preparation of global value dossiers which presented the product value propositions and the supporting evidence, aligned with the product development strategies and agreed/endorsed by the GPTs, GBTs, Regional HEOR and market access, for optimal value demonstration of products. Oversaw the implementation of literature reviews to build payer evidence, economic models, and Global Value Dossiers. Directed and oversaw the implementation of global cost effectiveness and budget impact models for HTA submissions to support reimbursement of indications for oncology and cardiovascular productsParticipated in the decisions on HEOR and RWE communications including manuscripts, scientific forum presentations, slide decks, symposia, in collaboration with multi-functional teams, built peer reviewed published evidence support for value propositions for assigned products. Managed external consultancies and contractors, ensured delivery according to key milestones, budget and to agreed and expected quality. Supported maintenance for continued enhance knowledge about HEOR methods and the evolving public health policy and reimbursement environment in major (USA, Europe and Japan) and other marketsDirector, Pharmaceutical Care ServicesNew York Health and Hospitals Corporation, New York, NY 1/1988 2/1991Consistently achieved expected results outlined in the New York and Hospital Corporation leadership competencies including providing leadership for strategic planning/execution to achieve expected productivity, quality, performance improvement, financial management, and human resource management. Partnered with pharmaceutical companies to develop and execute clinical research strategies that increased new revenue by 20% and increased study patient population by 30%.Planed, tracked, and managed all aspects of the trial(s), including the financial aspect, pivotal regulatory trials and potentially Investigator Initiated Trials and marketing trials in collaboration with clinical development partners and managed all resources (FTE, budget, etc.) to ensure successful completion.Possesses in-depth knowledge of Pharmaceutical, Biologics/Biotech, Hospital, Pharmacy, familiarity with adding products to Hospital Formularies, demonstrated ability to build and maintain positive relationships with management, peers, and subordinates. Proactively partnered with senior leadership and the business community to identify and prioritize opportunities to achieve the goals of the company; designed and executed outcomes strategic alignment with the organizations objectives.Experienced with billing, drug formulary management, medical and pharmacy benefits/policies, investigations, prior authorization, and appeals processes, managed the dynamics of Specialty Pharmacy with its Specialty Distribution requirements.EDUCATIONPharmD, Doctor of Pharmacy, University of Minnesota, Minneapolis, Minnesota.MBA (Marketing), Rutgers University, New Brunswick, New JerseyBS Pharmacy, University of Minnesota, Minneapolis, MinnesotaClinical Research Fellowship in Cardiovascular Pharmacotherapy/Cardiac Transplantation, UNC, Chapel Hill, NC.PROFESSIONAL LICENSES/CERTIFICATIONSRegistered Pharmacist in NJ & NY States.MEMBERSHIPS AND AFFILIATIONSASHP and NJSHP |
