Medical Director
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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
- 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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