22 set - Latina
Iqvia
Overview As Medical Director you provide medical oversight for clinical trials and serve as the primary medical monitor for sponsor-led studies. You act as the front-line medical resource for project teams, available around the clock to address protocol, eligibility, and safety inquiries. You work within a matrix team to ensure GCP-compliant activities, lead medical input across study documents, and collaborate with investigators and sponsor representatives. This role offers impact across protocol design, safety monitoring, data review, and cross-functional program leadership in a global clinical research setting.
Responsabilità
Provide medical and scientific input to study protocols, ICFs, CRFs, analysis plans, and regulatory submissions Ensure activities align with GCP and operate efficiently Interact with clients and sponsors to shape study design and endpoints Develop medical monitoring plans and provide on-call support for protocol queries Review SAE narratives and safety data; coordinate with Safety Management Oversee data review of eCRFs, data analysis plans,
and final study reports Support DSMB/adjudication processes and sponsor communications Assist with business development activities and feasibility discussions Draft SOPs and contribute to quality improvement efforts Coordinate with a network of medical/scientific consultants and supervise Medical Director activities
Requisiti fondamentali
Medical Degree from an accredited school 10 years of relevant experience (clinical practice, academia, clinical research, or drug development) 3–5 years of biopharmaceutical industry experience preferred Strong ability to work independently and within a multidisciplinary, matrix environment Excellent oral and written communication and interpersonal skills Board Certified / Board Eligible in Oncology (Required) with preference for Urologist / Surgical Oncology Ability to translate concepts into practical approaches and drive consensus Capacity to manage multiple projects with shifting priorities communication teamwork independence GCP compliance protocol development and review SAE reporting and safety signal assessment
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