Medical Director- Radiologist Home Based

This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. The Medical Director, Medical & Scientific Affairs role will fit under then ICON Clinical Research, Global Technologies/Imaging group.  The position directly supports Global Technologies 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.  . This position will report to the VP Medical Affairs or designee.

Overview of the Role

• 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 ICON Technology 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

• Responsible for leading and motivating project and study teams.
• Lead medical and scientific efforts to deliver timely and complete deliverables to clients
• Develop skills within medical and scientific teams as well as operations to better understand the concepts behind the objectives of clinical trials in order to better represent ICON within each sponsor study

Act as mentor to operations and medical staff in the role of a CRO in the drug development process

Role Requirements / Skills / Experience Required 

• 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 programs
• Thorough knowledge of US and ICH-GCP
• Excellent communicator that can effectively speak in public forums
• An 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.

• M.D and/or Ph.D
• Training in radiology
• Training in scientific research

Working for ICON you will be provided with an excellent benefits package.

We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.   

In addition you will have the opportunity to develop within your role and take on further responsibilities or develop your skill set within other related departments of ICON.

Following your application if you are successful you will be invited to an initial telephone interview with one of our dedicated recruiters who will be able to provide you with more details of this opportunity.