Bio

A great team player and natural leader with experience leading Development Operations at preclinical and clinical stage biotech companies, overseeing work across all of R&D including Preclinical/Translational Medicine, Toxicology, and Regulatory Affairs as well as Clinical Operations, Clinical Development, Biostatistics, and Data Management. Managed large teams including external consultants and multiple vendors. Over 20 years of drug development experience, focused in clinical operations and development, with expertise building out operational teams and quality infrastructure to support rapid clinical development programs as well as clinical trial start-up and execution. Experienced in the rare disease and gene therapy space, including neurological diseases such as spinal muscular atrophy and Duchenne muscular dystrophy as well as oncology including solid and hematologic cancers. Managed multiple large global development programs including nearly every region, but with significant experience in US, Canada, Europe, Australia, and Japan. Directly contributed to NDA/BLA filings for four successfully approved products and managed pivotal trial programs for four additional products that led to marketing approvals. Led inspection teams and inspection readiness activities for FDA and EMA inspections. Proven track record of successfully leading teams and projects to achieve the organization's goals. A strong focus on process improvement resulting in the identification and implementation of streamlined and efficient operations. Strong interpersonal skills with the ability to build rapport at all levels within an organization as well as cross functional teams across all functional areas throughout the organization.