Medical Director, Med & Scientific Affairs

Medical Director, Medical & Scientific Affairs

Radiology

Location: Remote (anywhere in US)

The position directly supports ICON Medical Imaging and provides support to ICON including ICON Clinical Research, Clinical Outcomes, ICON Labs and any other division that requires expertise in radiological assessment of medical imaging to develop and win new business, enhance present business quality of service, or complete ongoing trials for submission to the regulators. The position will provide medical and scientific expertise for the development of business and the planning, direction and analysis, as required, for all aspects of clinical trials. The position requires expert and detailed knowledge of all phases of the drug development process including biomarker development, adaptive design, submission to regulators and after-market studies.

Job Responsibilities Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.As a Manager, the employee is expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.Travel (approximately 10%) domestic and/or international.Provide in-house medical leadership for sponsor studies, including document development (imaging manual, charter/read methodology, SRS (system requirement spec), training manuals and others as needed), imaging and clinical outcomes protocol design and setup, quality control, independent reviewer methods and methodology and reviewer training and re-training;Support and work with staff and Business Development to provide expertise and support in the development of new business with potential clients and in building and retaining relationships with current clients. Support will consist of but not be limited to participation in bid defences and capabilities meetings, establishing a relationship with client medical and scientific experts, identifying new areas of research and providing internal training of ICON personnel on emergent developments in clinical research.Make independent decisions that represent the core business, medical and scientific positions within ICON and the Medical Imaging group.Support ICON responses to Request for Proposals (RFPs) and RFIs (Information), providing input that showcases IMI expertise in the scientific, medical, and technical aspects of imaging in clinical trials;Offer real time consultations internally and externally; internal consulting for technical and scientific questions includes providing training to other team members; external consulting includes study protocol development, site support, radiology case review for equivocal efficacy evaluation, imaging analysis guidance, contrast usage, study read design and read criteria application; Build relationships with clients by working/meeting/consulting with clients on study protocol development, providing insights on the imaging and protocol development component (related to point 3); help answer relevant queries from regulatory authorities by justifying study design;Conduct Independent Reader training for various read criteria, offer IRR Q&A, perform inter-reader variability analysis and re-train independent readers;Attend scientific and industry conventions, give talks/presentations, participate in imaging standardization groups;Maintain academic affiliation and foster IMI growth as a credible scientific leader

Job Requirements Board Certified in RadiologyM.D and/or Ph.DAn advanced academic background in the medical sciences that includes the pharmaceutical sciences. Extensive experience (>20 years) in a drug development culminating in a position of Sr. Director or above is an acceptable to substitute for an academic degree.In-depth expertise in imaging clinical trial endpoints with comprehensive experience in all phases of drug development.Excellent and demonstrated interpersonal skills that includes negotiation through difficult situations and leadership in large-scale projects and programsThorough knowledge of US and ICH-GCPExcellent communicator that can effectively speak in public forumsTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions