Clinical Operations Leader with 25+ years experience:

  • Managing the operations of complex global portfolios spanning all phases of development
  • Building, guiding, and mentoring small and large teams across geographies to deliver on portfolio goals
  • Managing clinical study budgets up to $300 million and operation budgets of $25 million
  • Developing effective sponsor-CRO relationships
  • Implementing efficient and compliant processes to support study delivery and inspection readiness

 

Therapuetic Areas

  • Rare diseases including: spinal muscular atrophy, amyotrophic lateral sclerosis, trigeminal neuralgia, hemophilia A&B, sickle cell disease, hemolytic disease of the fetus and newborn, myasthenia gravis, and various pediatric indications

  • Neurology, CNS and neurodegeneration: multiple sclerosis, Alzheimer’s, pain, Parkinson’s, stroke, schizophrenia, bipolar, depression, autism

  • Additional:  immunology (Crohns, ulcerative colitis, lupus), oncology (melanoma), cardiovascular (hypercholesterolemia, hypertension, cardiac imaging)

 

Accomplishments

  • Mid and late stage clinical operations, filing preparations, and inspection readiness of many programs and studies leading to regulatory approvals and line extensions:

    • Dimethyl fumarate/Tecfidera, peginterferon beta-1a/Plegridy, and daclizumab/Zynbrita (multiple sclerosis)
    • Recombinant Fc fusion proteins/Eloctate and Alprolix (hemophilia A and B)
    • Yervoy/ipilimumab (malignant melanoma)
    • Abilify/aripiprizole (schizophrenia, bipolar)
    • Cardiolite/Technetium Tc99m Sestamibi (pediatric cardiac imaging)
    • Pravachol/pravastatin (pediatric familial hypercholesterolemia)