United States
Senior executive with 18+ years in the biopharmaceutical industry, leading global clinical development programs from early stage to commercialization. Expertise in oncology and rare diseases, regulatory submissions, and cross functional team leadership. Proven track record managing multi million dollar budgets, complex clinical programs, and pivotal Phase III trials. Passionate about advancing novel therapies that make a meaningful impact on patients’ lives.
Lead clinical development strategy and execution for oncology therapeutics portfolio. Manage cross functional team of 45+ professionals, overseeing budgets, timelines, and portfolio planning from Phase I III. Spearhead design and execution of pivotal Phase III trials, resulting in successful NDA submissions. Drive operational excellence and cross functional collaboration to accelerate development timelines.
Managed clinical programs in immunology and rare diseases, leading clinical scientists and CRAs. Played a key role in due diligence for in-licensing opportunities and strategic development planning. Successfully led a compound from Phase II through marketing approval. Oversaw regulatory interactions and data review, ensuring compliance with global standards.
Designed and implemented Phase I/II clinical protocols. Provided scientific oversight for CRO management, data review, and medical monitoring. Authored key sections of INDs and annual reports submitted to regulatory agencies. Mentored junior clinical scientists and strengthened internal SOPs for trial execution.
Conducted site initiation, monitoring, and close out visits for US based clinical trials. Ensured compliance with protocols, GCP, and regulatory requirements. Supported early stage clinical program implementation and data collection.