SUMMARY:

• Talented R&D Regulatory Affairs and Clinical Affairs Program Leader with over 30 years’ experience creatively working with and positively delivering results from matrix team members and aligning with executive management developing Vaccines, In Vitro Diagnostics (IVD), Medical Device, Pharmaceutical, Software as a Medical Device (SaMD), Companion Diagnostic (CDx), Artificial Intelligence (AI), Monoclonal Antibodies (MAB), and Chromatography Resins at Sponsors/CROs.
• Effective project managing Phase I - IV clinical trial designs, implementing ICH, FDA, EMA clinical plans, writing protocol and informed consent, launching EDC systems, study team management, policy review and interpretation, alliances, business development, budget, and contract management, overseeing the regulatory management of multiple products, developing Agency deliverables, constructing stage gate slides, and communicating with KOLs.
• Skilled Clinical and Regulatory Technical Writer of SOPs, literature searches, 510k, IB, IFU, CERs, CRFs, CSRs, DSURs, iPSP, SAP, SAEs, IND, BLA, 510(k), PBRERs, PIP, PMCRs, Clinical Hold Complete Responses, and NDA and PMA sections.
• Expert evaluating data and information and high ability to influence and negotiate stakeholders including FDA.
• Experienced applying guidances, processes, laws, and regulations in manufacturing, research, and clinical development.
• Broad therapeutic knowledge in cardiology, endocrinology, gastroenterology, gynecology, hematology, immunology, infectious, oncology, orthopedic, pain, psychiatric, rare disease, and surgical.

TECHNICAL SKILLS:

SOFTWARE: Amazon S3, Argus, Aris Six Sigma, Bioclinica, Box, CDASH, Centerstage, Clinithink, CSS, CuratorCR, Data Analytics, DistillerSR, Documentum, Esca Medline Complete, Dataflux, eCTD, EDC (Inform, Medidata Rave), EndNote, Endpoint IRT, EXTEDO, iMedNet, Informatica, Infosaro, Innotas, IVRS, JIRA, LegalSuite, LIMS, Lotus Notes, MedDRA, Medidata EDC, MedLine, MS Office Excel/Outlook/Teams/Project/Project Server/Visio, Planisware, PleaseReview, Prisma Flow Chart, PubMed, Office Timeline Pro, Oracle Argus Clinical/Inform, Quickbooks, Rosetta, SAP, SAS, Sharepoint, Smartsheet, Spotfire, Trackwise, Veeva Vault, WebEx; WHO-DD, WordPress, Workfront, and xHTML.

PROFESSIONAL EXPERIENCE:

Director, Global Regulatory Affairs

Confidential

Responsibilities:

• Led obtaining CBER approval expanding the US Boostrix USPI with maternal immunization and Shingrix Coadministration.
• Combination Device URRA submission to support a vaccine presentation to eliminate the need of a Human Factors Study.
• Author, reviewer, and approver of US relevant sections of non-clinical, clinical, labelling, safety, manufacturing/CMC documents submitted to FDA and ensuring these documents meet high scientific standards and regulatory requirements.
• Drive enterprise thinking to develop and motivate collaborators within RA team and in multidisciplinary teams to achieve quality output, accountability, and recognition across the organization and towards the FDA with Information Responses.
• Global Leadership Team member to provide IND expertise to the EU R&D development team of a new vaccine and device.

Lead, Regulatory Affairs

Confidential, Gaithersburg, MD

Responsibilities:

• Led regulatory strategy development and implementation for two federal Combination Device programs using a stage gate commercialization process to submit an IND and iPSP and to lift a Clinical hold with Information Responses to FDA.
• FDA Agency and BARDA contact with subject matter experts (SME’s) in Clinical Operations, Nonclinical, Pharmacokinetics, CMC Manufacturing, Quality, and Project Management to ensure US FDA submissions technical content are accurate.

Lead, Medical Affairs (IITs)

Confidential, Boston, MA

Responsibilities:

• Executed US Investigator Initiated Study (IIT) $20M research and chaired Local Committee Review.
• Led alliance management with Legal, Finance, Medical Science Liaisons (MSLs), Medical Affairs, Statistics, Regulatory, Shipping, and Compliance to derive budgets, protocols, and contracts and improved program regulatory compliance.
• Launched a Post Authorization Progress Study (PAPS) dashboard to capture safety events, shipping, and milestones.
• Reason for leaving: The purchase of Agios products and staff shifted the program priorities.

Senior R&D Program Manager

Confidential, Boston, MA

Responsibilities:

• Provided executive level support and oversaw teams comprised of Principal Investigators, Data Analysts, Pharmacovigilance, Biostatisticians, Finance, Legal, and Project Managers conducting cardiology clinical trials, pharmacoepidemiology, epidemiology, and biostatistical, and genomics research.
• Led business development activities to create project budgets, contracts, and timelines.
• Reason for leaving: Initially remote but OIG changed rule Confidential staff must reside in MA.

IRB Board Member (remote)

Confidential, Newburyport, MA

Responsibilities:

• Provided GCP ICH protocol, HIPAA Informed Consent, and safety data guidance to pharma and med device sponsors.
• Reason for leaving: Company sold.

Director, Clinical Research (remote)

Confidential, Franklin Lakes, NJ

Responsibilities:

• Performed ongoing review and analysis of study safety and efficacy data.
• Provided support as needed for scientific issues arising during study execution.
• Collaborated with multi-departmental groups to develop consistent language and criteria for the Vitro Diagnostic Directive (98/79/EC, Informed Consent Form (ICF), protocol eligibility, protocol safety, and Case Report Forms (CRFs).
• Authored clinical scientific documents cross-functionally.
• Developed FDA relationships, contracts, hiring, and budgets with consultants.
• Understood the asset’s biological mechanism, clinical strategy, and scientific interpretation of disease-based literature.
• Understood and supported creation of competitor landscape, medical need, and EU CE Mark/FDA regulatory strategy.
• Performed literature searches and summarized the relevant scientific, product development, and medical literature to support product development.
• Managed clinical research project managers, wrote Clinical Quality SOPs, and produced program data analytics.
• Reason for leaving: Laid off due to Covid-19.

Regulatory and Clinical Program Consultant

Confidential, Cambridge, MA

Responsibilities:

• Developed a software as a medical device (SAMD) human interaction clinical plan FDA De Novo strategy.

Regulatory and Clinical Program Consultant

Confidential, Cambridge, MA

Responsibilities:

• Developed a companion diagnostic (CDx) integrated 8 yr., 16M CEP and FDA IDE/PMA strategy and budget.

Regulatory and Clinical Program Consultant

Confidential, Cambridge, MA

Responsibilities:

• Created R&D plans and timeline, audited lab data and recommended for Electronic Lab Notebooks (ELN) vendor.
• Formulated an accrual budget, selected clinical and regulatory CRO vendor, and edited CMO ISO Quality Plans.

Regulatory and Clinical Program Consultant

Confidential, New Haven, CT

Responsibilities:

• Realized partnerships between Data Science and industry to support NGS research and technology development, with the goal of developing Artificial Intelligence (AI) software to benefit Confidential ts by project managing resources, confidential disclosures, statement of work, licenses, and contracts to acquire $1.7M DS purchase requisitions and matrix managing data scientists, legal, finance, clinical, hospitals, and vendors while ensuring compliance with legal policy.
• Audited and managed the R&D 7M accrual SOX budget and portfolio KPI reports to Management, Legal, and Finance.
• Led the phenotypic technical team to develop a Guinness World Records®NGS assay with Edico Genome’s genomic data-crunching computer chip, DRAGEN, Illumina’s high-throughput sequencing instruments, Clinithink, EPAM, and staff at Rady Children’s Institute for Genomic Medicine.

Senior Program Director and Core Team Lead, R&D

Confidential, Bedford, MA

Responsibilities:

• Launched 4 new products and on-time executed Agile Design History CMC chromatography PMO deliverables and improved cross-functional R&D Core Team dynamics and the site stage-gate Product Commercialization Process (PCP): 10M Budget, 2-year Schedule, Risk Analysis, Alpha Tests/Report Verification and Validation Plans/Reports, Data Analysis, Design Review, Trace Matrix, Regulatory Package, and Quality .
• Produced analytics and insights based on NPV, resource forecast, time actuals, schedule data, and milestone data.
• Reason for leaving: Received severance due to off-shore scale-up transfer to Ireland from US.

Regulatory and Clinical Program Consultant

Confidential, Boston, MA

Responsibilities:

• Managed 4, US $8M budget Phase III Type 2 Diabetes clinical studies/CDP for combination device.
• Analyzed data and delivered 2 eCTD Clinical Study Reports (CSRs) for an NDA to win $100M venture capital funding.
• Alliance managed European and domestic clinical research business partners, vendor oversight, and compliance.
• Amended clinical protocol and created Interim Analysis SOP/SAE/ICSR/Data Process with C-Suite, CRO, IT, and FDA.

Regulatory and Clinical Program Consultant

Confidential, Minneapolis, MN

Responsibilities:

• Managed 12 site, 40 Confidential t orthobiologic phase III study, 4M budget, CDP, PV database, data man., and clin ops.
• Performed clinical data verification/ review, query management, coding, and data/ADR/ICSR reconciliation.
• Wrote eCTD sections, Confidential t safety reports, Literature Search Risk Assessments, Notice of Change, and CEP/CERs.

Regulatory and Clinical Program Consultant

Confidential, Danvers, MA

Responsibilities:

• Mitigated company legal risk and protected Confidential ts by auditing and reconciling 510k/technical file/dossier submissions with SAP/DHF/Trackwise to result in a $150M cardiology guide catheter recall and corrective labeling,

Regulatory and Clinical Program Consultant

Confidential, Cambridge, MA

Responsibilities:

• Preserved $100M contracts by reducing phase IV clinical CAPAs via Trackwise auditing and resolving CRO client contract, safety, budget issues, conducted regulatory intelligence, and reported metrics to Compliance.

Regulatory and Clinical Program Consultant

Confidential, Danvers, MA

Responsibilities:

• Mitigated an FDA warning letter and prepared for a Japanese audit for device approval by rebuilding the clinical standard operating system and regulatory templates including integrating the data vendor.

Regulatory and Clinical Program Consultant

Confidential, Canton, MA

Responsibilities:

• Managed US west coast clinical research/CDPs, counseled EU and US clients on regulatory compliancy with responses, wrote protocols/510ks/CERs/IFU/Notice of Change/Literature Search, and audited Phase I/II medical device GCP eTMF.

Regulatory and Clinical Program Consultant

Confidential, Allston, MA

Responsibilities:

• Reduced GMP CAPAs via Trackwise to prevent further penalty at a site charged with FDA Consent Decree mandates by matrix managing engineers to formulate installation, commission, and qualification plans for bioproduction.

Regulatory and Clinical Program Consultant

Confidential, Waltham, MA

Responsibilities:

• Led an international medical team to approve and initiate an integrated phase I and II clinical trial CDP, Phase III protocol, and statistical plan of a polyclonal antibody for the prevention of chronic Graft vs Host Disease GvHD for unrelated stem cell transplantation in adults. Included reporting safety data and writing study reports.

Clinical Research Scientist

Confidential, VA

Responsibilities:

• Wrote/edited scientific reports, IBM contracts, NIH grant applications, and Red Cross 510(k)/technical dossiers.

Senior Program Director, Clinical Research

Confidential, Charlottesville, VA

Responsibilities:

• Managed full-service contract for 31-site Phase II study evaluating the effect of treatment on hospital acquired pneumonia due to Methicillin-Resistant Staphylococcus aureus.
• Directed Phase IIb study/CDP evaluating the effect of treatment on atherosclerosis disease as measured by IVUS and angiograms in subjects undergoing coronary angiography who have coronary artery disease.
• Led Phase IIb out Confidential t study/CDP in irritable bowel syndrome involving 200 sites and 1800 screened Confidential ts.
• Managed Phase II study/CDP including PV reporting evaluating the effect of treatment on Alzheimer’s disease.
• Launched for primary efficacy data collection via Interactive Voice Response (IVRS).
• Performed data verification, data review, query management, coding, data reconciliation, and SAE reconciliation.

Senior Global Program Director, Regulatory and Clinical Research

Confidential, Arlington, Virginia

Responsibilities:

• Won $800M new business with presentations of regulatory strategy, budget, and proposed teams.
• Managed global medical device/IVD and pharmaceutical clinical research teams to meet global Phase I-III trial objectives in diverse therapeutic areas- oncology, cardiology, infectious disease, ortho device, and gastroenterology.
• Administrated 6 direct Clinical Project Managers and matrix-managed global teams, vendors, budgets, imaging retention and reports, supplies, PV database, and .
• Developed medical and regulatory writing deliverables-CDPs, protocols, case report forms, and integrated summary of safety (ISS), Periodic Safety Update Reports (PSUR).
• Performed TLF data verification, data review, query management, coding, data reconciliation, and SAE reconciliation.
• Primary Contact with the Sponsor and Regulatory Authority and direct report to VP, R&D.

Manager, Regulatory Affairs and Clinical Research

Confidential, Gaithersburg, MD

Responsibilities:

• Managed execution of all facets of global phase I to III clinical studies for SR Carbatrol for antiepelepsy; SR Adderall for narcolepsy; SR Selegeline for Parkinson’s disease and drug addiction; and SR Oral Acyclovir for Viral infections.
• Spearheaded company Phase II FDA successful meetings and direct report of VP, Medical Research.
• Led writing of all FDA regulatory submissions-IND, IB, Adverse Events, Annual Reports, NDA template, SAP, Bioanalytical Reports, CDPs, PV reports, and CIPs.
• Performed TLF data verification, data review, query management, coding, data reconciliation, and SAE reconciliation.
• Managed 4 direct reports and managed CRO and bioanalytical and imaging vendors ( Confidential ; PPD).

Project Manager, Chemistry, Manufacturing, and Controls, (CMC)

Confidential, Framingham, MA

Responsibilities:

• Influenced stakeholders and drove GLP transformation of GMP facility with matrix management of 120 inter-department staff to obtain FDA approval for transformative Ceredase.
• Liaison to Regulatory Affairs for CMC/BLA submission, FDA Audit Team member, and direct report to Site Manager.

Manager, Quality Control Analytical Laboratory

Confidential, Lexington, MA

Responsibilities:

• Developed pre-clinical assays and managed 4 direct report Chemists using Capillary Electrophoresis, HPLC, UV/VIS Spectroscopy, TOC, Endotoxin, LCMS, Particle Size Analysis, Osmolality, TEM/SEM, and tissue culture methods for protein purification and communicated technical reports to clients.

Research Scientist

Confidential, Boston, MA

Responsibilities:

• Developed assays for IL-3, Factor VIII, and Factor IX research and communicated results with management.