Results-focused, business-driven Medical Affairs leader with over 25 years of success contributing to global pharmaceutical initiatives, leveraging business knowledge, scientific expertise, and exceptional integrity and teamwork to drive patient-centric results.
• Exceptional at creating business development opportunities, directing the full lifecycle of projects/products, and creating business intelligence systems to enable automated financial management and core business operations functions.
• Keen understanding of Medical Affairs, including pain points and solution development, deployment, and operations.
• Adept at building relationships with internal and external stakeholders.
• Highly effective interpersonal, influencing, and negotiation skills.
Project Management Professional (PMP – 1571669)
Project Management Institute, Agile-Certified Practitioner (PMI-ACP – 2142206)
Lean Six Sigma Black Belt certified (11327416), currently finishing Master Black Belt program
Scientific expertise including stem cell transplantation, flow cytometry, ADC, Biomarker Dev, GxP System Design, Requirements, and Guidelines • SDLC • Agile and Waterfall Methodologies • Robust Financial Acumen • Complex Data Analysis • System and Data Governance • Change Management • Continuous Process Improvement
|Last Resume Update||February 5, 2021|
Investigated male factor infertility and in vitro fertilization optimization techniques.
High-Throughput DNA Sequencing / T-Cell Cloning Scientist
Using the single-strand conformation polymorphism (SSCP) technique followed by sequencing, identified first mutational library of brca1 mutations in 1,000 women at risk for germ line mutations in brca1 (paper NEJM), brca2/bard1 genes. Created retrovirally transfected, donor-derived, recipient-specific cytotoxic T-lymphocytes to prevent rejection of DLA-haploidentical marrow-stem cells transplants and regulating graft vs. host disease (GVHD) post-transplant.
Antibody Drug Conjugate Scientist
Member of the Translational Biology group co-developing in vitro and in vivo models for drug validation testing. Contributed to the IND submittal of ADCETRIS® in less than 18 months by collaborating with all functional areas, including Biochemistry, Clinical, Chemistry, and Process Development departments. Developed company-wide system integrating scientific data from all departments.
Biosimilars Development Scientist
Developed interactive and cross-functional scientific database for analyzing data and reporting project status. Negotiated and managed contracts with vendors, trained research personnel, and planned/executed experiments as well as advanced development of in-house small drug and recombinant-fusion cytokine therapeutic agents. Built in-vitro testing platforms while designing in-vivo studies to evaluate and compare in-house drugs.
¬ Created robotic (BioMek 4000), cell-based HTP drug screening system to test single and combination chemotherapeutics on Prostate, Lung, Melanoma and Myelodysplastic Syndrome cancer cell lines.
¬ Designed large Pharmacokinetic/Biodistribution studies comparing oral, IP, IV, and SC routes as well as injection schedules of small drugs or protein cytokine therapeutics in mice/rats.
¬ Maintained consistent progress toward in vivo histopathological and toxicological results by establishing contracts with companies that possessed essential services in analysis and interpretation.
¬ Demonstrated efficacy of therapeutic compounds using human and mouse (syngeneic) solid tumor (breast, lung, colon, pancreatic, melanoma, and ovarian) and disseminated lymphoma models (Burkitt's multiple myeloma) within multiple strains of mice.
¬ Collaborated with Institutional Animal Care and Use Committee (IACUC) members to respond to concerns and inquiries regarding in vivo studies.
Associate Director, Medical Affairs (IT)
Responsible for managing Gilead Medical Affairs Solution Delivery, working closely with the Business Engagement Lead, and Medical Affairs business partners. Manage numerous systems/applications, on varied platforms and verticals, in various stages of System Development Lifecycle (SDLC). Partner with the Application Support Organization on resolution of problems/issues/maintenance. Utilize experience working within Medical Teams and Medical Business Operations to provide Medical Affairs-driven perspective.
¬ Partner with Medical Affairs Leaders to develop and deliver 3-yr strategic technology roadmaps
¬ Lead the Medical Affairs Global team through requirement gathering, design, development, iterative testing and deployment of the Global Medical Information Response system (IRMS to Veeva), Investigator Sponsor Research system (iEnvision to Appian custom solution), Medical Scientist (field-based) mobile solutions (legacy to Egnyte custom solution), gilead.com Medical Affairs web pages, portal design/deployment, Medical content optimization project to deliver Veeva Vault and associated processes, Library Information Services (QUOSA virtual library, InfoDesk mobile app) for enterprise medical journals and database for field based medical professionals
¬ GxP system design/SDLC, coordination with validation, qualification, and regulatory compliance teams leveraging both agile and waterfall methodologies
¬ Design complex integrations with Clinical Operations, Adverse Event Reporting, Commercial CRM, Active Directory, MDM, using GxP & non-GxP middleware integrations (Informatica, Dell Boomi, Apigee, Azure SCIM, others)
¬ System Manager for legacy and new global solutions carefully coordinating IT modernization and maintenance initiatives, managing technical support team
¬ Ability to build cross-functional partnerships, engage in and lead cross-functional initiatives with teams and other key stake holders
¬ Excellent oral and written communication skills
Principal Project Manager, Medical Affairs & Medical Business Dev
Member of the Oncology Medical Team contributing to the 3-yr Strategic Medical Plans, Launch Readiness Reviews (LRRs), Study Management team, Compassionate Use and Access Solutions programs. Designed and managed Medical Affairs Business Intelligence infrastructure to create Key Performance Metrics for Senior Leadership, managed 189 external vendors, 60 Ad Boards/15 Steering Committees/>80 Real World Evidence studies annually, financial forecast and actuals of $100M budget, responsible for contract management, Managed Care Fair Market Value (MC-FMV) analyses, and continuous process improvement, managing 20 commercialized products across 18 therapeutic areas
¬ Partnered with Medical Director in the development and execution of Genentech 3-yr Medical Plans, strategies, objectives, tactics and resources
¬ Member of Study Management Teams (SMT): Clinical Trial prioritization/planning, protocol approval (scientific/budget), business process SOP
¬ Identified organizational remit of Medical Affairs functional groups (ClinOps, MedComm, MedEd, MSL, MCL, Scientific Collaborations) by reviewing benchmarking reports, creating value propositions, statistical analysis, and worked with groups to develop KPIs for Executive Leaders
¬ Created Resource and Capacity Management (FTE demand forecasting) solution/analysis and executive slide deck for estimating accurate staffing resources using Planisware
¬ Built automated financials for Oncology division, performed monthly reconciliations (invoice and accruals) and creating long-term (17 year) Oncology product strategy and scenario planning
¬ Created and implemented key compliance processes and training for Event Management, Managed Care Fair Market Value (MC-FMV), advisory board compliance, and all forms of contracting in accordance with changing business requirements, laws and regulations, such as U.S. Anti-kickback Statute, False Claims Act, Stark Law and similar ex-U.S.
Cellular Immunotherapy Scientist
Streamlined data outputs of various experimental instruments into an automated analytical tool for use by entire process development group. Served as member of GMP-regulated cancer vaccine development team within cross-functional Cellular Immunotherapy department. Managed PROVENGE® product activities, including initial, in-process, and final GMP processes.
Leveraged expertise in cGMP environments, utilizing ISO13485 and 21CFR820 regulations. Responded to Protocol Deviations, Exception Reports (ERs), and CAPAs that occurred within the GMP manufacturing facility. Established qualified, validated solutions by designing studies and writing Experimental Design (ED) protocols.
¬ Managed workflow and data integration for complex bioinformatics analysis automation, including flow cytometric acquisition and analysis as well as cell culture of APC-specific T-cell hybridoma/IL-2 assays and ELISA development/optimization as well as product stability testing data.
¬ Established and optimized final human cellular product shipping containment parameters. Developed and optimized changes in cell culture material component change testing and bag material/manufacturer.
¬ Developed automated workflow database compiler to input and analyze pre- and post-12 panel flow cytometric data, pre- and post-bioanalyzer data, and pre-/post-Coulter AcT5 Diff hematology analyzer data.
¬ Built and managed normal, healthy apheresis database comprised of HLA-DRb1+ for assay validation and optimization assays.
Biomarker Development Scientist
Created a high-throughput system for various cellular proliferation, cell death, macrophage/APC, and lymphocyte biomarkers. Validated ultrasound and colonoscopy imaging modalities to identify tumor initiation for pancreatic and colon cancer model development. Performed complex primer design to identify genetically engineered mouse models for pancreatic, lung, and colon cancer.
Performed high-quality RNA/DNA isolation of normal, primary tumor and metastases for microarray and CGH testing/analysis as well as genetic characterization and validation of murine pancreatic and colon tumor progression systems. Collaborated with small and large interdisciplinary groups for resourcing support and publication production. Presented results at numerous internal group, departmental, interdisciplinary, and offsite meetings.
¬ Developed High Throughput (HTP) Immunohistochemistry (IHC) system for optimizing various novel biomarkers. Optimized and validated oncology biomarkers (using Bond HTP autostainer and Leica Ariol slide scanner and Ariol review software as well as the Zeiss Axioplan II automated microscope), performing statistical quantitation of imaging analysis via Metamorph software.
¬ Performed large preclinical trials (Efficacy, Survival, PK, and PD) in IVF produced Genetically Engineered Mouse models (GEMMs) using standard of care (small molecules and/or antibody therapeutics) and novel therapeutics (single and combination MTD, single and combination efficacy/survival).
¬ Executed all study design, set-up, and statistical randomization as well as dosing, retro-orbital bleeds, necropsy, tumor, and metastasis tissue banking prep, data collection, graphing, and analysis.
¬ Cultured and characterized cell lines isolated from primary and metastasis sites from GEMMs via FACS.
MBA Finance Operations
Graduated May 2014 summa cum laude. Nominated by faculty for prestigious "Academic Excellence" award.
Activities and societies:
Business Systems Modeling, Corporate Financial Management, Enterprise Information Management, Financial Accounting, Global Operations Management, HR Management, IT Project Management, Legal and Ethical Dimensions of Business, Managerial Accounting Management, Marketing Planning and Analysis, Organizational Management Theory, Principles of Microeconomics, Probability & Statistics, Systems Management, Undergraduate Lecturer, and numerous graduate projects
BS Biology, Chemistry
Activities and societies:
Biology Department Assistant: Anatomy, Physiology, Embryology, Endocrinology, and Histology Departments
Two main jobs while attending college:
• Lead Laboratory Assistant for Endocrinology (performing live surgeries), Histology (performing all tissue preparation and immunohistochemistry staining, processing and analyses), Physiology (preparing all experimentation specimens and reagents), and Anatomy (prepared all specimens for students as guides to their own dissections).
• Research Associate at the East Tennessee State University James H. Quillen College of Medicine’s OBGYN department, researching male factor infertility as well as optimizing cell culture conditions for their human In-Vitro Fertilization (IVF) clinic.