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Medical Director/Senior Medical Director
hace 2 semanas
Medical Director/Senior Medical Director - Oncology - Clinical Trial Services
Remote Romania
Job Type: Regular Full-time
Division: Precision for Medicine
Business Unit: Clinical Solutions
Requisition Number: 4774
Precision for Medicine is hiring a Medical Director/Senior Medical Director - Oncology to join our team. Candidates can work remotely in any of the following locations: Italy, UK, Spain, Poland, Hungary, Romania, Serbia or Slovakia.
The Medical Director serves as the project physician and provides medical and scientific expertise to project teams. The Medical Director's primary focus will be to ensure the accuracy and integrity of the data resulting from the trial, with a concentrated focus on patient safety.
Essential Functions:- Work closely with senior leaders in Medical, Operational Strategy, and Business Development to support client engagement.
- Support Business Development and Proposals teams by participating in the RFP process; prepare medical considerations section for proposals; and support or participate in bid defense meetings.
- Write or edit scientific content of deliverables within budget and timelines.
- Collaborate with Regulatory Affairs on regulatory product landscape and strategies as part of overall drug development strategy.
- Provide scientific insight and create content for specified company releases (e.g., white papers and publication manuscripts).
- Review and revise protocols, case report forms, training materials, project specific tools, analysis plans, study designs, clinical trial reports and new drug applications.
- Review laboratory values, adverse events, coded adverse event and medication data, and data tables, listings and figures as needed.
- Serve as a medical resource for study sites, the project team and clients.
- Assist in the preparation of the Medical Monitoring Plan and materials for investigator meetings and staff training sessions.
- Assume responsibility for medical and safety monitoring on assigned projects.
- Participate in feasibility discussions relating to specific project proposals.
- Develop training modules and provide training concentrating on disease states.
- Participate in process improvement activities.
- Collaborate with Senior Vice President, Global Medical and other members of the Medical Science Department to support growth and development activities globally.
- MD, DO, MBBS, or equivalent medical qualifications.
- 5+ years of clinical experience.
- 5+ years of experience in oncology clinical research.
- Board Certification in Oncology.
- Demonstrated expertise around the lifecycle of oncology drug development with ability to strategically analyze oncology clinical trial protocols.
