Medical Director- Oncology

at  GE Healthcare

JOB DESCRIPTION SUMMARY

In this role, you will be leading the clinical development strategy of the Contrast Media and Molecular Imaging products under your responsibility in the Oncology domain. You will be responsible for designing and executing clinical development plans across the global businesses. As such, individual will have extensive cross-functional interaction within the Company, ranging from pre-clinical through to clinical, regulatory and commercial functions worldwide.
Our Pharmaceutical Diagnostics (PDx) business is the number one global supplier of contrast media and molecular imaging agents used to enhance medical imaging exams. Used throughout all major disease area diagnostic and treatment pathways, PDx products support three patients every second around the world.

REQUIRED QUALIFICATIONS

• Medical Degree
• Substantial experience in Pharmaceutical, Biotech, or Contract Research Organization leading to good understanding of Clinical and Industry development of drug products.
• A proven practice in Oncology (preferably with Imaging experience) in both academia and industry is requested.
• Proven experience in Good Clinical Practice (GCP) Clinical trials
• Must be willing to travel as required.
• Experience working with Microsoft office products (Word, Excel, PowerPoint, Outlook)

• To provide clinical leadership in cross-functional projects and product/project teams
• To be responsible for the development and validation of the overall medical strategy of the assigned product(s) with appropriate internal or external experts, and for the agreement on this strategy with the appropriate internal business stakeholders
• To be responsible that project activities are planned, agreed and executed according to the milestones and the overall clinical development plan (it includes pre- and post-marketing activities)
• To be responsible for the timely and accurate completion of project documentation such as protocols, amendments, case report forms and study reports
• To verify scientific accuracy of safety and efficacy summaries for regulatory/commercial purposes and to assist with the clinical sections of regulatory dossiers and or product specific scientific discussion, depending on pre or post-marketing activities
• To work closely with the Risk Management, Compliance, Regulatory Affairs and Pharmacovigilance teams to establish and maintain strong risk assessment and management processes for decision making
• To provide input into Risk Management reviews as it relates to patient safety, the performance of risk assessment in the design of clinical studies, and the interpretation of patient safety and risk in the post-market environment
• To collaborate with multiple functions for identifying and selecting innovative products for development
• To work with internal teams and external experts to design clinical development plan and to support clinical research strategies for regulatory approval, reimbursement and adoption.