**12419BR** **Title:** Director, Clinical Science & Data Integrity **Job Description:** Lead the organization’s clinical science function and ensure the quality and integrity of all clinical data communicated internally and externally. Job duties: + Drive the development and management of the clinical science organization via procedure implementation, training, and ensuring timely execution of deliverables. + Provide hands-on leadership of the clinical science function in clinical study design, development, and support efforts. + Ensure holistic scientific support to Clinical Research throughout study lifecycles, acting as a member of the extended core team for all clinical studies. + Lead clinical science team in the robust analysis of study data, development of tables, listings, and figures (TLFs), and preparation of related reports. + Ensure integrity of all clinical data generated and communicated outside the organization for the purposes of regulatory submissions, publication, podium presentations, and marketing communications, and implementing processes and standards as appropriate. + Oversee clinical scientists in their support of publication and initial presentation of clinical study and meta-analysis results including timeline development, preparation of required data, review with PIs/authors, preparation of draft presentation slides, manuscript review/feedback, and assurance of reported data integrity. + Prepare, manage, and communicate timelines and project plans related to clinical science deliverables. + Partner with Regulatory Affairs, Clinical Research, and Medical Affairs leadership in the development of regulatory strategies and preparation/review of clinical content to support regulatory submissions. + Develop and maintain relationships with external business partners including key opinion leaders, biostatisticians, and other scientific experts. + Maintain a high degree of knowledge in the neurovascular space, staying current on new developments and providing perspective to the business on the treatment landscape. + Communicate clinical study information and results to physicians as needed. + Support internal and external training programs as required. + Serve as a subject matter expert for collaborative support, review, and approval of promotional material referencing clinical data. + Represent the organization at professional and industry meetings, conferences, advisory boards, and in other interactions with thought leaders. + Work closely with cross functional leadership including Clinical Research, Regulatory Affairs, R&D, Marketing, and PACE. + Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization. + Perform additional duties and responsibilities as assigned. **Auto req ID:** 12419BR **Location:** Aliso Viejo, California, USA **Department Name:** 527-Medical Affairs **Qualifications:** 1. Bachelor’s degree in a related field of study. 2. A minimum of twelve (12) years of relevant professional experience with a minimum of eight (8) of those years in the medical device industry. 3. A minimum of five (5) years of management or leadership experience. 4. Knowledge of the neurovascular space, including products, therapies, and anatomy. 5. Demonstrated experience in study design and data analysis with a focus on data integrity. 6. Ability to work well in a fast-paced team environment. 7. Detail oriented. 8. Proven analytical abilities and organization skills. 9. Excellent written and verbal communication and presentation skills. 10. Ability to establish strong relationships with key opinion leaders, peer groups, and other outside parties to further departmental and corporate objectives and goals. 11. Understanding of regulatory requirements and guidelines such as FDA and CE mark process. 12. Proficient with MS Word, Excel, Outlook, and Teams. **Desired Qualifications** 1. Experience in the neurovascular device industry. 2. Experience in clinical research operations and knowledge of related regulations. **External-Facing Title:** Director, Clinical Science & Data Integrity **Posting Country:** US - United States **Salary Range:** $153,198 - $214,477 (Compensation could be higher based on education, experience and skill sets) We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, ethnicity, disability, religion, national origin, gender, gender identity, gender expression, marital status, sexual orientation, age, protected veteran status, or any other characteristic protected by law.