Medical Director Neurology

Job Category: Biotech/R&D/Science Company: Baxter Healthcare Reference Code: 31401BR Medical Director Neurology Baxter International Inc., assists healthcare professionals and their patients with the treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients' lives. The Medical Director is primarily responsible for ensuring the safety of clinical trials. The Medical Director is also responsible for directing medical functions of the department, clinical development, new approvals, regulatory reports and peer-reviewed manuscripts based on Clinical Studies of the division. Participates on division strategic teams including the identification of new indications for existing licensed products. Strategically supports clinical trials throughout the evolution of clinical trial design, execution and completion of the study, providing medical and technical support. Incumbent will provide medical technical perspective to the Business Development and Portfolio Management functions in the identification of potential partnering and internal opportunities. Shares medical expertise with his/her counterparts in other functional areas such as Manufacturing, Quality, Assurance, Regulatory Affairs, R&D, Legal and Marketing globally. The medical director will also be responsible for developing KOL network and KOL activity program(s) in neurology, relationship with regulatory bodies, support key advocacy groups in order to build Baxter’s market leader position in neurology. The medical director will develop the medical affairs plan in neurology. Review all reported adverse events in clinical trials of investigational products. Assess, query and recommend corrections to MedDRA coding of adverse events. Approve MedDRA coding of adverse events. Support and contribute to overall clinical research strategy, safety and conduct of clinical trials of products and/or new indication for a licensed product. Provide strategic leadership to the clinical R & D and medical affairs activities related to the evaluation and reporting of issues and adverse events related to products safety and efficacy, as well as strategies and activities associated with technical support for divisional products in the global clinical market. Provide medical and scientific direction on clinical matters affecting preparation and submission of timely and sound information to the global regulatory agencies. Work with product development and marketing functions to define the requirements and specifications for new products. Maintain knowledge base as to developments and trends in medical science pertaining to his/her area of responsibility. Contribute to the training, leadership and continuing education for all of Clinical R&D. Participate in the development and writing of Clinical Trial Protocols. Provide input to investigator’s brochure and interim/final CSR’s. Approve final clinical trial protocols, investigator’s brochures and clinical study reports. Work with the medical affairs team and provide overall planning and leadership in neurology. Serve as expert consultant to quality and medical vigilance functions in the investigation of adverse events and other product related issues. Assist as requested in the preparation of periodic and other regulatory reports. QUALIFICATIONS: The position of Medical Director requires a clinician whose previous education and experience supports their primary function of assuring the safety of clinical research subjects. Specifically experience in medical coding and classification and reporting of AEs and SAEs is required. The position of Medical Director has a worldwide scope and all clinical development activities must comply with Good Clinical Practice specifications as practiced in different geographies. This position requires excellent interpersonal skills, presentation skills and technical writing ability. The Medical Direct must be experienced in managing multiple tasks, multicultural teams, and in the design and conduct of GCP compliant clinical trials. The Medical Director must interact successfully with a variety of individuals both within and outside the BAXTER BioScience, which include clinical investigators, KOL, contract research organizations (CROs), medical providers, patients, regulatory officials and individuals of various advocacy organizations with a particular interest in our products and clinical trial outcomes. The Medical Director must possess a comprehensive clinical knowledge of the area under inquiry as well as a keen understanding of study design principles (e.g. identification of key study end-points, power analysis, etc.) The Medical Director must be fluent in spoken and written English M.D. degree, with active medical licensure in at least one country Excellent written and verbal communication skills, as evidenced by publications and public speaking. Certification in a specialty appropriate to the products of the TA to which assigned. Ten or more years experience after completion of residency, at least three of which involve clinical activities. Four years experience serving as a medical professional in a pharmaceutical/biotechnology company. As a global leader dedicated to building the best team in health care, Baxter offers competitive compensation and full benefits. To view other opportunities at Baxter, please visit our Careers@Baxter site. EOE M/F/D/V.