SVP- Medical & Scientific Affairs

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The Position

The Opportunity

The Chief Medical Officer is responsible for working in partnership with the Medical and Scientific Affairs Department and global Roche Diagnostic business areas to support the RD-US Medical & Scientific vision and strategies. The Chief Medical Officer provides direction in three key areas: 1) Strategic product development by leveraging clinical knowledge; 2) Scientific excellence as it relates to clinical management and studies and product requirement; and 3) Development and exchange of medical and scientific information about disease diagnosis and disease management. Serves as a spokesperson on clinical matters in a wide variety of venues on behalf of RD-US. Works closely with the Chief Executive Officer and other members of the Senior Management Team to provide leadership for RDC’s growth. Responsible for strategic planning, goal setting and operations of the Medical and Scientific Affairs organization.

Provides senior level direction or guidance for a significant organization or part of the business; responsible for multiple functions, departments, and/or geographic marketplaces.  Sets strategic vision and direction; develops and implements strategic plans and objectives for the organization in alignment with corporate strategy.  Typically has overall control of planning, staffing, budgeting, managing expense priorities, and approving changes to methods and practices for assigned business area.  Decisions impact entire Division.

Responsible for maintaining and continuously improving the quality system and achieving quality objectives through daily actions.

Key Roles and Responsibilities

• Directs diagnostic development focus to disease management; captures additional economic value for new diagnostics through outcomes-based studies that demonstrate improved patient benefits and cost effectiveness.

• Develop relationships with national thought leaders to: 1) Stay current on the latest experimental treatment and their commercial opportunities; 2) Convene advisory boards for trial designs or to confirm appropriate product use or potential use of new products; 3) Maintain company brand visibility on a professional level; 4) Understand clinician’s needs and requirements and influence medical practice patterns; 5) Drive treatment protocol, adoption and appropriate reimbursement; 6) Ensure cutting edge industry trends.

• Serve as RDC’s clinical spokesperson in a wide range of venues both internally and externally such as professional society forums, customer sites and relevant corporate functions.

• Provide input into product development; generate clinically robust and ethical Investigator Initiated Studies (IIS) and complete Health Hazard Evaluations to determine potential patient impact. Coordinate the use of outside Medical Opinions and ensure collaboration of internal medical and scientific resources.

• Work with the clinical and medical groups within the global organization to identify and implement collaborative studies, regulatory activities and other programs. Keep abreast of international research in related fields.

• Provide input to new business and market development activities in North America, including new business ideation and touchpoints with North American market development.

• Shape product development and drive the establishment of new standards of care; increase sales force disease management knowledge and understanding to enable appropriate clinical adoption of new technologies. Increase credibility and clinical voice through physician-to-physician relationships using strategies such as symposiums, web sites and marketing materials.

• Provide medical and scientific input into regulatory submission (PMA and 510ks) and provide and gather adequate medical opinions to assess health hazards, adverse events and potential product recalls. Provide guidance and assistance to regulatory submissions personnel with regard to strategies for product approvals. May serve as a member of the RDC Corrections and Removal Committee.

• Responsible for budget management to ensure business needs are met while being fiscally responsible.

• Support a high quality team to meet the needs of the business of today and the future. Individual development to ensure a high level of effectiveness and long term personal and professional growth.

• Ensures the RDC Quality Policy is unders