Seasoned Clinical Research Professional with 20+ years of diverse experience spanning large pharmaceutical companies, contract research organizations (CROs), and biotechnology firms. Adept at leading cross-functional, global studies across various phases of drug development and therapeutic areas.
Broad Clinical Trials Management Expertise:
– Extensive background in managing Phase I, II, and III clinical trials across a wide range of indications.
– Hands-on experience in all aspects of clinical trials, including protocol implementation, data entry, and electronic data capture (EDC).
Project Management Acumen:
– Skilled in developing robust operational project plans, including milestones and timeline scenarios.
– Successful management of Phase II/III study operational aspects to ensure adherence to timelines, budget, and quality objectives.
External Relationship Management:
– Effective collaboration with cross-functional internal and external partners, including pharmaceutical companies, CROs, and global stakeholders.
– Adept at fostering productive partnerships and navigating diverse cultural, regulatory, and operational environments.
Financial Management Expertise:
Experienced in global vendor contract review, approval, and budget oversight and reconciliation within Pharma, CRO, biotech and research sites.
Therapeutic Area Specialization:
Extensive experience in Oncology, spanning several indications, and Respiratory (Asthma and Allergy).
Significant expertise in conducting global studies across a variety of therapeutic areas, including:
– Phase II Serious Ovarian
– Phase I Recurrent Glioblastoma
– Phase III Recurrent Glioblastoma
– Phase II/III Colorectal Cancer (CRC), Metastatic Colorectal Cancer
– Phase III Prostate
– Phase II Advanced Non-Small Cell Lung (NSCL)
– Phase I Pancreatic
– Phase II CRC, Advanced Breast Cancer
– Phase III Soft Tissue Sarcoma
– Phase II Advanced Melanoma, NSCL, Breast and Gynecological Cancers
– Early Oncology and Hematology