Supporting global field strategies by bridging the gap between the day-to-day field operations and the technical systems. Contributing to alignment and integration of a rapidly growing pre-launch global field medical team through collaboration with field medical, medical information and IT regarding strategy, operations, metrics, and best practices.

Member of Operations team, supporting strategies with multiple stakeholders, primarily focused on field medical and medical materials review. ▪ Operations-CRM Platform: Veeva CRM, OL Identification/development utilizing Veeva LINK.o Developed interactive MSL territory Dashboard for new Veeva CRM Lightning UI via cross-functional collaboration and agency for MSLs to view and efficiently manage territory metrics.o Created interactive online CRM training manual using the Rise 360 platform to optimize MSL entry of HCP interactions.o Solved CRM issues, adjusted territory alignments and developed Approved Email.o Created KOL spreadsheets for MSLs and various Leadership utilization at medical congresses using Veeva LINK.o Proposed changes to Strategic Insight Questions for MSL Field interaction, providing actionable information retrieval and clear CRM Survey entry.▪ Operations MMRT (Medical Materials Review Team) utilizing Veeva MedComms.o Led planning and implementation activities as MMRT Coordinator with Medical, Regulatory, Compliance and other functional leads (Materials-QC, meetings, agendas, minutes and Veeva MedComms platform Manager).o Resolves various submitter questions for submissions, uploads, process and final QC.o Updated and finalized SOP, collaborated with Compliance to facilitate training for all functions.o Collaborates with submitters and M/R/C to identify pain points, compromise and enable better review process.o Developed processes (Expedited Review) and added specific Renders to close loopholes, keep documentation within the system of record and improve efficiencies and deliverables.▪ General Operations.o Led/coordinated with Function Leads to develop monthly GMSA Leadership Team monthly report, ensuring timely and accurate completion.o Updates, streamlines and distributes weekly medical inquiry and monthly speaker meeting reports to MSLs.o Engages MSL field team and leadership to problem solve CRM issues and other process inquiries.

Recruited to lead medical affairs operations, reporting to the Vice President, Medical Affairs and Chief Medical Officer. Responsible for strategic and tactical operations planning for ISRs (investigator sponsored research), medical education grants and congress activity, and process management for field medical operations. ▪ Skills and ability recognized early, resulting in direct contributions in strategy development for field operations and congresses, including field team and commercial communications.▪ Developed strategies for ISR Program operations, including the ISR grant review and MRC (medical review) committee meetings, issue resolution and follow-up.▪ Developed SOPs and policies for ISR & Med Ed Grants, approved in less than three months; created auditable ISR files.▪ Proactively developed positive cross-functional working relationships (medical, regulatory, legal, med info/safety, distribution, sales ops, field MSLs, finance and administration).▪ Facilitated and enhanced Grant & Medical Review Committee process improvements, including agenda development, pre/post question resolution, prepared submitter and participants, communicated results and updated stakeholders.▪ Lead conduit for communication, follow-up and updates regarding ISRs to field investigators and MSLs.▪ Identified potential new KOL/HCP targets, competitive intelligence, and possible speaker opportunities, to/for the field team.▪ Collaborated, with Agency, to facilitate development of online forms and interactive website portal for ISR & Med Ed Grant submission, congress planning, abstracts/presentations and audience targeting.▪ Processed, edited and approved documents and presentations in Veeva Promo Mats for ISR and MRC.▪ Led vendor management, including interface with Finance, to process new vendors and regular payments (SOW/PO-Intacct).

Professional Development 2018 – PresentDeveloped and implemented a self-funded professional learning plan designed to strengthen and expand depth/breadth of industry trends, scientific knowledge, clinical/medical affairs operations and general business acumen through continuing medical education (CME), course work and seminars. (See attached complete list.)

Recruited as a member of the initial sales team to build and manage a new Hem/Onc territory for Bexxar, a radiolabeled anti-CD20 monoclonal antibody radioimmunotherapy for treating Non-Hodgkin’s lymphoma (NHL) in bone marrow transplant, expanded access. Co-promoted Hycamtin and Kytril within key accounts. ▪ Cultivated strategic partnerships with KOLs and healthcare professionals at academic and medical institutions, including Memorial Sloan Kettering Cancer Center, Cornell University, Columbia University, Mt. Sinai Hospital, Beth Israel Hospital, St. Vincent’s Catholic Medical Center, Yale University and New York University. ▪ Increased awareness and momentum for the understanding of the Bexxar patient journey through building relationships and communication between key departments (Medical & Hematologic Oncology, Radiation Oncology, Nuclear Medicine, Radiation Safety, Nursing and Nuclear Medicine).▪ Coordinated/facilitated the adjustment of oncology legal radiation outpatient release allowance for I-131, across multiple stakeholders (KOLs, radiation safety, key institutions) for all NYC patients to benefit from expanded access.▪ Led proposal development and submission of an operational road map for an eventual Phase IV Group and Project Management Team.▪ Created internal partnerships with executive management, marketing and clinical to solve account-specific issues to ensure product access and outpatient release.▪ Provided scientific knowledge/business insights to key stakeholders for issues and resolutions for market intelligence, training and pre-launch planning. ▪ Represented company at medical meetings and conferences (ACSO, ASH, IBMTR).▪ Grew sales by 522% within two territories for Hycamtin and Kytril (more than one year).

Recruited to raise awareness of Prograf (proposed new indication in BMT) and AmBisome (anti-infective for BMT) through creating/cultivating relationships between physicians, staff and management at Comprehensive Cancer Centers.▪ Developed and coordinated with Head of BMT the first MSL/BMT fellowship program at the University of Michigan.▪ Appointed MSL Project Lead (within three months of hire) for the AmBisome Phase IV Multicenter U.S. trial; developed/implemented a comprehensive project in 2.5 months (CRFs, CRO management, training, presentation).▪ Worked with thought leaders to broaden product utilization by reviewing concepts derived from retrospective/prospective review of patient results for use in publication or practical use.▪ Coordinated KOL meetings and attending appropriate medical education programs to solidify relationships and address product related questions or general issues.▪ Addressed and resolved issues/concerns to ensure support or sufficient funding for potential publication or single center/multicenter phase IV trials. ▪ Appointed to attend U.S. Food & Drug Administration Advisory Committee meetings regarding potential BMT indication approval for Prograf. ▪ Represented company at medical meetings and conferences (ASCO, ASH, IBMTR).

Recruited to lead all strategic and tactical aspects of a Clinical Operations Department (Phase IV trials), leading, planning and executing trials for pharmaceutical company clients (including Abbott/Hytrin and Parke-Davis/Lipitor). ▪ Reacquired lost business from Clinical Research Head of Parke-Davis in first week by presenting a comprehensive plan for managing clinical trials, including adverse events, retrieving data, maintaining communication/follow-up.▪ Developed clinical SOPs, including double-data review plan, CRF queries management, proper adverse event reporting and SAE report completion & timing.

Recruited to lead Wyeth’s Rapamune Pivotal Phase III 42 multi-center trial. Oversaw 21 regional direct reports. Responsible for all trial site management, client relationships, distribution, payments and compliance. Promoted to Senior Project Manager in first six months.▪ Inherited trial post-initiation, with no deadlines met, and swiftly turned the project around.▪ Transformed project, conduct, execution and results by creating and implementing an organized plan to meet every deadline on time and on budget.▪ Hired and trained direct reports (in multiple time zones) to complete study using open communication and planning tools.▪ Co-monitored high enrolling sites and retrained new hires as needed maintaining trial continuity.

Responsible for managing all aspects of the Enlimomab Pivotal Phase III (48-center) trial using an anti-ICAM-1 murine monoclonal antibody. Promoted to Senior Medical Research Associate in first year.▪ Led planning, training, proactive CRF retrieval and follow-up, achieving a database lock prior to the Phase II trial. ▪ Developed CRF, conducted all pre-site/site initiations, trained site staff and the regional clinical research associates. ▪ Responsible for regulatory completion, product distribution, site payments, SAE follow-up, concomitant medication issues, queries, monitoring follow-up; handled issues pertaining to internal departments/trial site staff.▪ Managed one Medical Research Associate and regional clinical research associates.▪ Traveled up to 60% to ensure trial status.

Recruited to develop and manage trial sites for a Pivotal Orlistat Phase III Clinical Trial – Orlistat. Promoted to Senior Clinical Research Associate in first year.▪ Created and managed all aspects of the Investigator’s meeting in Florida for all 43 centers. ▪ Fully trained and managed several sites across the country, traveling 85%; completed pre-site visits, ICF completion and follow-up, regulatory responsibilities, site initiations and management, monitoring, queries, adverse events, concomitant medication follow-up, drug accountability, follow-up and SAE reporting. ▪ Co-monitored to assist other CRAs as needed. ▪ Co-developed Multi-Laboratory Action Plan (domestic & international shipments) for all sites to order, complete and ship all labs required for this complex trial.