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Medical Director - Oncology , Sponsor Dedicated (Home-Based)

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
Offerta di lavoro pubblicata 3 giorni fa
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