Chapel Hill, North Carolina, United States
Experienced, field-based Senior Medical Science Liaison (MSL) focused on Hematology, Solid Tumor Oncology, and Immunotherapy (I/O). Specialties: Medical Affairs, KOL Engagement Strategy, Scientific & Medical Communications, Superior Presentation Skills, MSL Training and Development, Investigator Initiated Research, Medical Education, Medical Publications, Clinical Research, KOL Segmentation, Field Deployment Strategy, Competitive Insights, Advisory Board Strategy, Sales Training, HEOR.
• Field-based Senior Medical Science Liaison (MSL) in immuno-oncology, experienced in establishing collaborative relationships with global, national, and local KOLs, as well as community practice HCPs (MDs, APPs, BCOPs), serving as a bridge between clinical development and the medical community. Responsible for site selection and activation for company-sponsored clinical trials, evaluating investigator-initiated research ideas, working throughout a product’s clinical and commercial lifecycle to identify gaps and potentially inform strategic decision-making through delivery of medical and scientific education. • Supporting the scientific development & commercialization of marketed Multiple Myeloma products Ninlaro (ixazomib) and Velcade (bortezomib); as well as the Leukemia product Iclusig (ponatinib) in CML and Ph+ ALL. • Molecule Lead: TAK-981 (Subasumstat), a novel SUMOylation inhibitor for CD20+ lymphomas, CD38+ myeloma, and solid tumors. • Early clinical development support for TAK-007, a novel, off-the-shelf CAR NK-cell therapy for CD19+ B-cell malignancies. • Committed to the advancement of innovative development pipeline therapies including Pevonedistat in MDS, CMML and AML; Alisertib in AML; and immunocytokine Modakafusp / TAK-573 (CD38-IFNα attenukine) in MM. • Therapeutic areas of interest include: Multiple Myeloma (MM), B-cell Non-Hodgkin Lymphoma (B-NHL), Chronic Lymphocytic Leukemia (CLL), T-cell Lymphoma (PTCL, CTCL), Chronic Myeloid Leukemia (CML), Acute Lymphocytic Leukemia (ALL), Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), Acute Promyelocytic Leukemia (APL), Amyloidosis, Hodgkin Lymphoma (HL), Myeloproliferative Neoplasms (polycythemia vera, essential thrombocythemia, and myelofibrosis), Hematopoietic Stem Cell Transplantation (HSCT), Graft vs Host Disease (GvHD), Neutropenia; CAR-T, CAR-NK & CAR-γδ (gamma-delta) T cell therapies.
I served as a medical and scientific resource for the medical community and internal stakeholders in therapeutic areas of interest to Teva Oncology. • I provided medical and scientific support for the following Teva Oncology portfolio products: Treanda & Bendeka (bendamustine), Synribo (omacetaxine), Granix (tbo-filgrastim), and Trisenox (arsenic trioxide). • Medical and scientific support for Teva/Celltrion monoclonal antibody biosimilar rituximab (Truxima, CT-P10) and biosimilar trastuzumab (Herzuma, CT-P6) for HER2+ Breast Cancer (Adjuvant and Metastatic). • MSL support for B. Braun/Teva medical device: OnGuardTM CSTD (closed-system transfer device). • Responsible for developing medical affairs strategy and driving medical content via publications, abstracts, medical communications, responding to field-based medical information requests, and facilitating Investigator Sponsored Studies (ISS). • Supporting Advisory Boards, CME Symposia and Congress activities; lead planner for ASCO and ASH Conferences. • Training and supporting new MSL hires, commercial sales and marketing teams. • Presenting disease state education programs to physicians, nurses and pharmacists. • Provide clinical input for Health Economics & Outcomes Research (HEOR) & Market Access strategy.
Working at the cutting edge of immuno-oncology for the innovator of the first FDA-approved cancer vaccine, providing scientific education for the following: • The use of Provenge (sipuleucel-T), the first and only FDA-approved immunotherapy for advanced prostate cancer. • Collaborating with academic leaders to facilitate Investigator-Initiated Trials (IIT), while maintaining GCP regulatory compliance. • Engaging in Scientific Exchange with prostate cancer community and supporting generation of clinical and immunologic data. • Understanding and effectively communicating scientific knowledge, including Dendreon products, competitive landscape, disease states, and research initiatives. • KOL relationship management; educating KOLs and other Healthcare Professionals (HCP); responding to unsolicited requests, strategies for territory management.
Manage cross-functional technology transfer teams which include manufacturing, R&D, analytical, quality, regulatory, and business development units focused on reducing protein drug substance Cost of Goods through development of more efficient manufacturing processes. • Evaluate and implement improvements in manufacturing process yield, robustness, and regulatory compliance for Prevnar-13, BeneFIX and rhBMP-2/INFUSE® Bone Graft medical device. • Authored tech transfer and process validation sections for new FDA/EMA marketing applications for improved BeneFIX manufacturing processes. • Spearheaded implementation of the “Process Understanding Plan (PUP)”, a global initiative to provide centralized access to the development, clinical, manufacturing and regulatory knowledge accumulated over a product’s lifecycle.
Analytical team leader on two cystic fibrosis projects (VX-809, VX-661); responsible for End-of-Phase 2 (EOP2) close-out activities that transitioned to Phase 3 clinical trials. • Delivered monthly presentations to senior scientific management, clinical operations and business management with project updates on chemical, formulation, and analytical development. • Managed relationships with Contract Research and Manufacturing Organizations (CRO/CMO) for animal toxicology studies, synthesis of drug substance intermediates and metabolites, and the formulation and sterile packaging of clinical trial material (CTM). • Provided post-commercial launch support cystic fibrosis drug Kalydeco (ivacaftor) by conducting tablet formulation characterization studies for pediatric product line extension and single-tablet combination therapy studies. • Managed and directed three associate-level scientists and was a contributing member of cross-functional sub-teams and task forces for Clinical Phase II & III projects in Cystic Fibrosis. • Oversaw development activities including chemical and formulation development, analytical method development and validation, dissolution and stability testing, biopharmaceutical modeling, excipient compatibility studies, and clinical supply chain management.