REGENERON, New York, NY OCTOBER 2022 - PRESENT

PROGRAM MANAGER

• Develops, executes, and oversees overall program strategy by facilitating activities of cross functional Strategic Development Team from pre-IND through commercialization.
/• Responsible for developing an integrated project/program plan relevant to the team deliverables and ensures alignment across relevant functions and smooth transitions among pipeline stages. Leads annual goal setting sessions to develop project / program level goals that align with Regeneron’s overall goals and monitors progress against these goals.
/• Manages oversight of integrated program timeline and budget, management of variances and escalation where appropriate.
/• Fosters collaborative relationship across the alliance program teams to align on and execute strategic development plans.
/• Leads and facilitates collaboration between functional areas to ensure effective, accurate, and timely scientific/technical and program-related communication.
/• Creates new processes and leads the development of innovative solutions, collaborating with impacted stakeholders to gain alignment. Leads process improvement initiatives, ensuring they meet the business needs.

NYU LANGONE HEALTH, New York, NY MAY 2015 - OCTOBER 2022
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//DIRECTOR, MELANOMA & MERKEL CELL CARCINOMA RESEARCH PROGRAMS
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//Directs all aspects of the Melanoma and Merkel Cell Carcinoma research programs including but not limited to the management of all legal, regulatory/compliance, IT, data, sample processing and bio-banking aspects of the program. Provides ongoing systems analysis and process improvements by identifying and resolving project issues and constraints.
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//Orchestrated seven project teams towards the submission of a $20 million NIH grant to further melanoma research through the initiation, planning, execution, controlling and submission of each project.
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//Manages all program resources - recruiting and training new employees; project timeframes and budgets
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//Implemented the complete overhaul of the entire Melanoma Research program and establishment of the Merkel Cell Carcinoma program through the development of improved clinical and sample management databases, compliance procedures, training and work flow processes to enhance melanoma and merkel cell carcinoma research
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//REGULATORY MANAGER, CENTER FOR BIOSPECIMEN RESEARCH AND DEVELOPMENT MAY 2015 - PRESENT
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//Recruited by senior management to develop the infrastructure and manage all regulatory and compliance aspects that drives the consent of approximately 6 million patients annually across the entire medical center.
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//In phase I of the project, provided the resources required to successfully consent over 10,000 patients and bank their specimens to obtain NIH funded grants to permit research across multiple disease types.
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//Eliminated waste and inefficiencies across the medical center by consolidating duplicate bio-banks into the centralized bio-bank at the CBRD. Manage all program resources - recruiting and training new employees; project timeframes and budgets
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//LABCORP CLINICAL TRIALS, Cranford, NJ JUN 2013-APR 2015 PROJECT MANAGER
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//Accountable for successful delivery of assigned clinical trials projects by keeping study specifications and deliverables consistent with corporate and client expectations.
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//Coordinates and implements plans associated with kits and logistics, specimen management, data management, laboratory operations and third party vendors as required.
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//Ensures that validation and quality control requirements are fulfilled and documented on time and in accordance with standard operating procedures. Ensures all required internal and sponsor approvals are obtained.
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//Organizes kick-off meetings and/or training sessions as required to communicate study requirements internally and externally. Documents all required study training in project files. Attends investigator meetings to provide instructions on specimen collection, packaging and shipping procedures.
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//Provides daily management of the project through internal and external co-ordination and follow up during the project life cycle. Interacts with Project Team members to resolve and troubleshoot problems related to specimens, result reporting and site compliance. Provides sponsors and/or investigators with resolution to problems or referral to appropriate sources.
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//Reviews status of assigned projects through regular project team meetings. Provides additional updates and metrics as required to Supervisor, Business Development and/or Alliance Manager in support of broader global program oversight.
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//Proactively manages and anticipates risks to successful project delivery and escalates issues promptly in accordance with global escalation policy.
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//Maintains study budget and invoicing activities to ensure these aspects are always aligned.
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//ICON CENTRAL LABORATORIES, INC., Farmingdale, NY SEP 2002-JUN 2013
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//PROJECT MANAGER MAR 2012- JUN 2013
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//Primary contact for Global Clinical studies with multiple pharmaceutical and biotechnology companies for all matters regarding the central laboratories.
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//Generates a project charter or Clinical Laboratory Worksheet (CLW) with our clients for all new studies to facilitate the successful operation of the laboratory testing, site set up, Logistics, day-to-day management and proper closure of completed protocols.
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//Analyzes the potential risks that may be encountered during the course of the study within ICON and how these may affect the overall successful completion of the clinical trial. Work directly with the client on a contingency plan to mitigate the effect of these risks and their impact.
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//Cultivates client relationships at investigator meetings and also provides training to clinical study and site personnel and act as a liaison between the sponsor, third party facilities and internal departments within ICON Central Laboratories.
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//Work closely with Clinical Business Operations for the overall financial management of assigned studies.
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//Manage the development of clinical study budgets, procurement of outsourced services, and forecasting and tracking of actual vs. planned expenses.
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//Facilitates the reporting and accuracy of the budgeting and actual financial process.
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//Responsible for all operational and financial aspects of study management including the logistics of site set up and the global supply, re-supply of kits, providing cost analysis for proposed budget changes.
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//LEAD TECHNOLOGIST – MOLECULAR DIAGNOSTICS JUL 2010-FEB 2012
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//Promoted through positions of increasing profile and scope to direct the research and validation of molecular biology on a range of platforms in the Molecular Diagnostics department.
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//Direct onsite audits and deliver standard operating procedures/validation plans to clients and regulatory bodies.
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//Proficient in the research and validation of quantitative HIV and HCV assays on Roche Cobas, TaqMan and Ampliprep; HCV genotyping using Siemens Versant LiPA kit; EBV, CMV, HSV 1/2, VZV, CYP2D6, Apolipoprotein E, FactorII and V on the Roche LightCycler.
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//Highly experienced in performing DNA and RNA extractions from PBMC’s, whole blood, plasma and PaxGene samples for analysis using the spectrophotometer and Agilent BioAnalyzer.
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//Leverage deep knowledge of the project lifecycle to facilitate completion through to accreditation by the College of American Pathologists (CAP) and New York State Department of Health.
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//MEDICAL TECHNOLOGIST l & II– MOLECULAR DIAGNOSTICS MICROBIOLOGY& IMMUNOLOGY SEP 2002- JUL 2010
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//Partnered with senior-level scientists in new assay validation by observing quality control standards by the organization and the client.
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//Conducted real-time PCR assays in the Molecular Diagnostics department; trained junior technologists on the best practices for assay development.
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//Improved the storage and location of pharmacogenetic samples by introducing a new more efficient storage method.
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//Qualified in the set-up of sputum, swab, stool and urine samples on different agar types; culturing isolated colonies for identification using the Vitek instrument by Biomerieux.
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//Utilized antibody assays to prepare body fluids for testing; entered completed test results in the Laboratory Information Management System (LIMS) maintaining alignment with quality control standards.
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//Specialized in performing ELISA assays on HCV and HIV; Western Blot and RIBA. Validated Serum/Urine samples on the SPIFE 3000 for the characterization of monoclonal gammopathies.
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//ICON CLINICAL RESEARCH, Dublin, Ireland OCT 2001- SEP 2002
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//CLINICAL DATA COORDINATOR
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//Responsible for the entry of clinical data into Oracle Clinical and the administration of documents to produce ‘clean’ data management records that meet our clients and the FDA requirements.
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//Processed, logged and tracked clinical study documents in accordance with Case Report Form (CRF) tracking and Data Entry guidelines; Good Clinical Practices (GCP), 21 CFR, corporate Standard Operating Procedures and the International Committee on Harmonization (ICH) guidelines.