Principal and President of GeoSera:Global Clinical Development and Operations, leading a team of biostats, medical writing, medical and safety management, project management, TMF, CRAs, and data managers. ✪ Head of Operations – Responsible for corporate budgets and the deliverables of internal and external colleagues in non-clinical and clinical for small pharma for CNS-related disorders. ✪ Head of Clinical Operations for Parkinson’s Disease, Anxiety Disorders, Rare Kidney Disease, Ultra-Rare Eye Disorder/Gene Therapy, CAR-T Cell Therapy✪ Vice President of Clinical Operations - Global Clinical Research Organization (CRO) overseeing US clinical research and operations specializing in hypopituitary and endocrinology disorders, schizophrenia ✪ Senior Director of Clinical Operations – Migraine, Opioid Withdrawal, Post-Surgical Pain, Rare Kidney, and Hematologic Diseases✪ Senior Director of Clinical Operations and Project Management – Acute agitation in bipolar, schizophrenia, dementia and Alzheimer’s, and Opioid Withdrawal ♦ Led two positive phase III trials that had NDA approval in April 2022✪ Director of Clinical Operations – ultra-rare epilepsy, ultra-rare dermatology, Suicide Ideation in Bipolar Depression ✪ Clinical Trial Lead – rare Ovarian Cancer, phase I PK studies in patients and healthy volunteer studies

As Global Clinical Operations Leader, I led the following successful clinical trials for:✪ Adult Schizophrenia using implant technology, Phase I PK and Phase III studies for NDA submission✪ Adult Chronic Pain and Opioid Addiction of approved Brixadi™, a long acting depot of buprenorphine, Phase III and Phase I PK and Opioid Blockade studies I held budget and vendor accountability roles for 5 clinical trials ($55M combined budget) and ensured successful outcomes through effective management of 40 indirect reports across multiple studies, including CROs, central labs, IxRS, ePRO, EDC, data management, contract CRAs, medical writers and medical monitors. Accountable for Key Performance Indicators (KPIs), including budgets and timelines, vendor performance, and risk management. During my time at Braeburn Pharmaceuticals, I have:♦ Incorporated innovative ideas from competitive proposals to increase efficiency across clinical trials ♦ Orchestrated and executed protocol-specific training for vendors, site coordinators and Principal Investigators ♦ Created competitive Procurement & Supply Management process that lowered clinical trial budgets by 20% or roughly $10 million♦ Lowered budgets for and increased efficiency of clinical trials through implementing new advertising strategies, mobile technologies, eSource Documents, ePRO, and virtual investigator’s meetings to Executive Management ♦ Author of protocols, ICFs, Study Conduct Plans, CSRs, IXRS, ePRO and EDC specifications,study plans, Instructions for Physicians, data entry guidelines and IRB responses within Good Clinical Practices (GCPs) guidelines♦ Contributed operational information for journal publications to Medical Affairs♦ Conducted site initiation visits (SIVs), data metrics meetings, co-monitoring visits, data listings review meetings to provide high-quality oversight of clinical trials

As Lead for Clinical Operations and Medical Affairs, I led successful trials for:✪ Endocrinology: Adult and pediatric global, Phase II – III trials for biologic product Albutropin™✪ Chronic Pain, Breakthrough Cancer Pain and Inflammation: Schedule II, phase III trials with Vantrela ER™, Schedule II, Phase III trials with Fentora® and Sciatica, adaptive design, global, biologic phase I/II ✪ Investigator Initiated and Phase IV: Pain, Wake and Specialty products, Vantrela ER™, Adasuve®, Nuvigil®/Armodafinil, Amrix®, Zecuity®My role included managing multiple concurrent trials and vendors with budgets totaling $75M and ensuring effective communication of Executive Management decisions across 16 global, cross-functional teams. This included management of 20 indirect vendors including CROs, Data Management, ePRO, Regulatory Submissions, Central Labs, Imaging, Safety Committees, Key Opinion Leaders, Interactive Response Technologies, Drug Packaging, and Mobile Patient Visit Technologies. My accomplishments included:♦ Identified, selected and fostered relationships with vendors while reducing vendor contracts by using competitive proposals and the preferred provider vendor model ♦ Directed trial-related information across cross-functional teams to ensure that clinical trials were efficiently and effectively executed.♦ Created and led vendor bid defense meetings for the selection of vendors while collaborating with Supply Management/Procurement to negotiate and lower budgets♦ Co-authored Clinical Development Plans (CDPs) to design development strategies for phase I through phase III pivotal trials ♦ Co-authored protocols and sponsor responses to Regulatory Authorities, ICFs, IBs, CSRs, and aCSRs

My clinical study experience at Merck included participating in: Drug-drug interaction studies for PK/PD, bio-equivalence studies, first-in-man, single ascending dose studies, dose finding in Phase Ib and IIa, and single and multiple ascending dose safety studies. My responsibilities and accomplishments included:♦ Performed in-house clinical operational activities from start up, maintenance through close out of Phase I – IIa trials ♦ Led the Clinical Pharmacology close-out of Phase I studies by authoring and filing regulatory documents, i.e. CIBs, CSRs, aCSRs♦ Reconciled data queries with medical monitor, CRAs and sites closing out clinical trials by reviewing data in Clinical Trial Systems ♦ Co-authored Clinical Pharmacology protocols in accordance to ICH Guidelines in order to meet the Programs’ objectives in an efficient manner♦ Coordinated operational aspects of the clinical program such as forecasting drug supplies, maintaining and updating the trial master file and regulatory documents, corresponding with sites and IRBs

As a Clinical Program Assistant for Women's Health, I:♦ Served as a primary contact for inquiries from clinical investigators, CROs, CRAs, and the internal clinical operations team♦ Monitored/audited regulatory documents to ensure compliance with internal SOPs and regulatory guidelines and FDA/GCP/ICH guidelines♦ Developed Case Report Forms (CRFs) and document tracking spreadsheets for Phase II/III studies♦ Developed monitoring plans, study guides, project management plans and monitoring tools♦ Performed local interim monitoring visits to verify source documents and CRFs; reviewed protocol compliance, regulatory compliance and drug accountability♦ Provided study start-up, maintenance, close-out, reconciliation and regulatory document tracking support on multiple protocols

During my tenure with GSK, I:♦ Earned Impact Award for outstanding performance within DMPK 2004, 2005, 2006 and 2007♦ Authored SOPs and analytical methods for dose formulation analysis ♦ Trained in FDA regulations, compliance, inspections and readiness♦ Organized dose formulation schedule in order to efficiently perform dose formulation analysis via HPLC♦ Organized yearly Safety Assessment (SA) schedule as a member of the SA Committee ♦ Underwent internal process audits from World-Wide Regulatory and Compliance♦ Liaised with SA and World-Wide Bioanalysis (WWB) to ensure efficiency metrics were met ♦ Operated effectively under highly regulated conditions following FDA Requirements♦ Provided analytical and technical support to Clinical Research Organizations ♦ Coordinated with World Wide DMPK to streamline the drug development process♦ Strategized with System Business Support (SBS) team to meet business demands of DMPK♦ Expert with TotalChrom software for data acquisition and data management

♦ I used Millennium Chromatography software for data acquisition to perform formulation analysis using HPLC♦ I co-authored analytical methods for dissolution and dose formulation analysis♦ I organized data entry using Laboratory Information Management Systems (LIMS)

♦ I co-authored weekly reports to provide the Analytical Biochemistry team with the concentration of dose formulations ♦ I also authored, maintained, updated Standard Operating Procedures (SOPs) for laboratory use