Head of Clinical Affairs Siemens Healthineers, Point of Care Diagnostics Business Summary of Primary Responsibilities: The Head of Clinical Affairs is responsible for defining the vision and clinical strategies that will support meeting the Point of Care Diagnostics product development and commercialization objectives. The Head of Clinical Affairs is responsible for the design and successful execution of clinical trials that demonstrate medical product performance and ensuring that trials are conducted in full compliance to all applicable regulatory requirements. The role manages a staff of Clinical Project Manager(s), Clinical Research Associate(s), Clinical Trial Coordinators, Data Analysts, Collaborations, as well as external vendors such as CROs, Core Labs, and Medical Monitors. The Head of Clinical Affairs takes the leadership role for analysis and interpretation of clinical results for regulatory submissions and publications. This position reports to the Global Head of Quality for the business. Specific Responsibilities: · Strategic translation of business objectives into clinical requirements for clinical trials, investigator-sponsored studies, publications, and meeting regulatory requirements for clinical evaluations and post-market surveillance. · Manage and develop global internal team of Clinical Project Managers, CRAs, and Clinical Trial Coordinators. · Overall responsibility for design of clinical trials including protocol development, clinical trial discussions with regulatory authorities, and development of timeline and budget. · Manage the process of screening, qualifying, and selecting, and contracting with investigators, sites and vendors required for conduct of clinical trial. · Obtain necessary clinical trial approvals from IRBs/EC’s and regulatory bodies such as the FDA and Competent Health Authorities. · Ensure studies are on track for site initiation, patient recruitment and enrollment, and take corrective actions where necessary to address issues. · Ensure clinical results are interpreted and documented clearly and concisely for regulatory submissions and publications. · Maintain surveillance of published literature and clinical results for the business and competitive products across all pertinent indications for strategic purposes and use in regulatory submissions. · Develop, maintain, and expand collaborations with outside clinical investigators, researchers and thought leaders to facilitate the optimum performance of clinical development programs. · Develop work instructions to assure internal files and clinical study files (patient; site; country) conform to Good Clinical Practice regulations and standards. · Ensure adherence to protocols and compliance with regulatory (FDA/ICH/GCP) guidelines, and internal collaboration controls, as well as SOP procedures. · Identify clinical training needs and develop training materials for in-house and clinical site use. · Provide oversight of investigator-sponsored studies. · Develops budgets for all clinical projects and adheres to company financial goals. Job Complexity: The Head of Clinical Affairs will work closely with senior management to translate business commercial objectives into requirements for specific clinical trials and programs. This role is responsible for the successful execution of the clinical portfolio as well as the management, growth and development of the clinical staff. The position requires maintenance of up-to-date knowledge of all applicable international regulation and regulatory guidance, as well as in-depth product knowledge and clinical / medical knowledge of indications. The position requires the individual to have strong leadership, problem-solving, and decision-making abilities. Supervisory Responsibilities: Responsible for managing internal and external resources including Clinical Project Leader(s)/Manager(s), Clinical Research Associate(s), Clinical Affairs Coordinator(s), and activities of external Contract Research Organizations, vendors, core labs, medical monitors, data management, biostatistics, and investigational sites. Experience, Knowledge, and Skills Required: · BS, BA, BSN or RN or higher degree in the Life Sciences or related disciplines. Laboratory/Medical technologist experience is a plus. · Minimum 5 years in senior clinical management position in the med tech industry ideally in IVD/ medical device industry, CRO or academic/hospital clinical research environment. · Additional 5+ years direct experience in clinical trial management. · Solid track record in successfully executing Phase I – III clinical trials. · Demonstrated expert knowledge and comprehensive understanding of applicable GCP, ICH guidelines & FDA and applicable international regulations. · Strong, hands-on manager with experience in managing clinical affairs staff and CROs, Core Labs, Data Management, Biostatistics, and Medical Affairs Safety Reporting. · Knowledge of electronic data capture systems and web-based clinical trial management tools. · Excellent interpersonal, written / verbal communication & organizational skills. · Strong executive presence to interact with Executive Leadership Team and key internal and external stakeholders as needed. · Collaborative team player able to work cross-functionally and influence direction and clinical strategy based on their expertise and experience. · Strong program management and financial skills. · High level computer skills required (e.g. MS Word, Excel, PowerPoint). · Willing & able to travel domestically and internationally, as required (up to 30%). Siemens Healthineers has recently announced the next steps in our continued commitment to prioritize colleague health, comply with customer/business partner requirements, and help preserve our business continuity. Going forward, please be aware that Siemens Healthineers requires full COVID-19 vaccination for all new hires by their start date except where prohibited by state law. (Note: Accommodations may be requested for certain medical or religious reasons #LI-EM1 Organization: Siemens Healthineers Company: Siemens Healthcare Diagnostics Inc. Experience Level: Experienced Professional Job Type: Full-time Equal Employment Opportunity Statement Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. 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