- 15 years of pharmaceutical industry and clinical research experience.
Clinical Development, Imaging, and Research (oncology, small molecules, biologics, medical devices, and diagnostics); Clinical Development Plans; Scientific, Medical, and Operational Leadership of Clinical Trials (all phases); Clinical and Regulatory Strategy; Protocol Development; Site/CRO/Vendor Selection and Oversight; Data Analysis and Interpretation; FDA Submissions; Clinical Investigator/KOL Relationships; Leading Global Cross-Functional Teams; Medical Writing (regulatory documents and publications).
MD from CES University in Columbia, South America; board-certified physician, surgeon, and radiologist.
Consultant, Scientific Advisor, and Independent Reviewer
Advise pharmaceutical, biotechnology, and medical device industries on the use of imaging to determine effectiveness and safety of products. Specialties: oncology clinical development, radiology/medical imaging, contrast agents, and independent review. Independent radiology review for oncology clinical trials spanning morphological response criteria including RECIST, IWG criteria for NHL, etc. as well as for trial phases. Retained Scientific Advisor of Oncology for Perceptive Informatics (PAREXEL). Responsible for scientific validity of independent review charter templates for oncology, scientific oversight of core product software design and development, and to represent Perceptive at industry, regulatory, scientific, and business development events.
Vice President, Medical Imaging, Cardiocore (BioTelemetry, Inc.)
Oversee Imaging Division, developing scientific and business strategy to bring products and services to market in compliance with global regulatory and medical health requirements. Work with CMO to represent the medical department to key leaders of the business division and parent corporate leadership.
Global Head, Imaging (Oncology Clinical Development), Novartis Pharmaceuticals Corporation
As Director, Head, and Global Head, led and managed the Oncology Imaging group to support clinical studies within Oncology Clinical Development. Collaborated with the clinical lead of trials to design and prepare protocols and execute clinical studies, with special emphasis on imaging aspects and efficacy assessments (Phases 1-3). Oversaw collaboration with external imaging experts (e.g., imaging CROs, imaging key opinion leaders, etc.) and imaging vendor strategy/sourcing. Supervised imaging operational support of studies and the group’s contributions to Novartis-wide imaging-related initiatives (e.g., development of imaging standards, guidance, templates, etc.). Defined imaging strategies at a clinical trial level using relevant imaging modalities and biomarkers. Functioned as a subject matter expert and consultant to trials teams on imaging-related matters.
Head of Oncology Imaging and Senior Director of Medical Affairs, Perceptive Informatics, Inc. (PAREXEL)
Led the oncology therapeutic area team, directing and supervising the execution of the medical imaging component of worldwide oncology clinical trials. Advised pharmaceutical, biotechnology, and medical device companies on use of imaging to determine product effectiveness and safety. Liaised with regulatory authorities, coordinating and leading meetings with the FDA. Optimized use of DCE-MRI and PET imaging for “go/no go” decision-making in Phase 1 and designed protocols through meetings with FDA in Phases 2-3. Guided successful submissions of oncology drugs to the FDA with a few obtaining “blockbuster” status. Participated at Oncology Drug Advisory Committee (ODAC) meetings as a radiologist and clinical trial expert.
Medical Director of Oncology, Perceptive Informatics, Inc. (PAREXEL)
As Assistant Medical Director, Medical Director and Medical Director of Oncology, provided expertise on imaging-related projects to evaluate safety and efficacy of investigational drugs and devices. Worked with clients to develop strategies to use imaging in clinical trials. Assisted in study design to standardize imaging techniques in multi-center trials and consulted with clients on medical imaging issues. Supported preparation of clinical protocols, journal articles, and other documents. Guided customization of image analysis software tools to meet business needs, providing appropriate training to key staff and subcontracted radiologists and site personnel.