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)