Job Description

Job Title: Director, Global Clinical Evidence & Medical Affairs Job Location: Flower Mound, TX, USA Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: Director We are excited to be named one of the World’s Best Workplaces by Fortune Magazine! We are proud to offer you 12 paid holidays annually. For an overview of our benefits and time off, please follow this link to learn more: US Stryker employee benefits. The Director, Global Clinical Evidence and Medical Affairs provides direction on the overall clinical evidence generation, scientific writing, physician engagement and medical safety within the global NV business. More specifically, responsible for creating and maintaining all processes and managing all clinical individuals responsible for generation of clinical study reports, regulatory-required routine reports, publications, podium clinical presentations, MDR-specific deliverables, CER/CES, etc. to the Global NV business. Primary focus of role is to maximize the leverage of clinical data generated by Stryker-sponsored research, Investigator Initiated research, Collaborative Studies, literature and Stryker-initiated Clinical Science (small studies, metanalyses, papers, CES/CER, etc.) and secondary focus of role is on establishing/improving major Clinical processes that enable the generation of high-quality data in the most efficient manner as possible. Essential Duties & Responsibilities Provides direction on all global clinical evidence generation, scientific writing, physician engagement and medical safety. All processes utilized by the Biostatistics and Data Management organization related to trial database generation, management, report generation, programming, medical coding. All processes related to CER/CES generation for MDR, NMPA and other global regulators requiring similar types of Clinical evaluation and/or summary reports. All processes that lead to or rely on Medical Writing, including Clinical Study reports (SSR, IIR, Collaborative Studies, etc.), CER/CES, regulatory-required annual reports, Summary of Safety & Clinical Performance (MDR), Periodic Safety Update Reports (MDR). Management of all electronic systems, tools, databases, templates utilized for Biostats and Data Management. All processes related to the presentation and/or publication of NV-related clinical information and general overall marketing communications. Manages the Medical Writing and Advance Evidence groups focusing on research supporting past, current and future trials. In addition: Establishes clinical policies and interprets, executes, and recommends modifications. Develops and implements Clinical organizational structure and supervisory relationships. Ensures strategic alliances with physicians, key opinion leaders, third-party monitors, core laboratories, CROs, consultants, etc. Participates in driving quality awareness in every employee. Develops and implements an organized, continuous process for staff development. Responsible for development of realistic clinical department budgets, schedules, and performance standards. Interacts with senior level management concerning significant Clinical matters. Conducts briefings and technical meetings for senior management and clinical investigators as needed. Analyzes, prepares and presents data from external/internal sources. Guides Clinical employees in support of following clinical trial management processes and procedures. Contributes to the development of corporate-wide clinical standards for content and quality of clinical trial data. Participates in internal and external audits as they occur. Drives policies and processes that incorporate innovative trends and practices in clinical research. Ensures awareness and compliance with applicable standard operating procedures. Co-ensures that employees are notified of all mandatory training and quality obligations. Education/Special Training Required Degree in science/health related field (e.g., Biology, Nursing, Biomedical or Veterinary Sciences) preferred. Alternatively, degree in Business, MBA, Program Management or equivalent. Qualifications/Work Experience Required 12+ years Clinical Sciences experience in the medical industry (device, pharmaceutical, biotechnology). At least 5 years in a managerial capacity managing clinical programs and clinical professionals. Leader with demonstrated success in building a culture of inclusion and collaboration. Deep understanding of governance associated with conducting clinical trials. Medical device industry experience is required. Competency Expectations: Excellent organizational and project management skills. Demonstrated success in developing clinical department infrastructure. Understanding of laws, regulations, standards, and guidance governing clinical studies. Pro-active, energetic, self-assured professional. Analytical, strategic thinker with leadership ability. Excellent people management skills. Fluency in English, one additional language preferable. Excellent communication and presentation skills. Salary: $145,700 - $321,000 plus bonus eligible and benefits. Actual minimum and maximum may vary based on location. Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, and more. #J-18808-Ljbffr Lifelancer

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