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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.  With the clinical project team, collaboratively develop trial protocol, case report form, complaint management plan, and final study report. Oversee the authorship the trial Safety Plan, Clinical Events Committee Charter, Data Management Committee Charter. Supervise the assessment and triage adverse events, escalating to committee(s) as appropriate. Monitor Clinical Events Committee meetings and the adjudication processes. Assess and trend in-trial metrics including: patient risk and report to post-market surveillance as appropriate. Underlying goal is to obtain and maintain a clinical leadership position in the global NV community.

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Essential Duties & Responsibilities

Provides direction on all global clinical evidence generation, scientific writing, physician engagement and medical safety. Areas of focus would include:

• All processes utilized by the Biostatistics and Data Management organization related to trial database generation, management, report generation, programming, medical coding to name a few.

• 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. This can include processes that relate to the generation of 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), to name a few.

• All reports needed for secondary regulatory approvals beyond US, Japan, China and Europe to allow for regional pre-market approvals.

• 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 as well general overall marketing communications.

• Manages the Medical Writing and Advance Evidence groups focusing on research supporting past, current and future trials; ensure literature review, ad-hoc analysis, meta analyses, etc. are conducted robustly yet efficiently.

In addition:

• Establishes clinical policies and interprets, executes, and recommends modifications.

• Develops and implements Clinical organizational structure and supervisory relationships with direction and support from division Global Customer Excellence, Global Commercial Excellence and Clinical Affairs senior leadership.

• Ensures strategic alliances with physicians, key opinion leaders, third-party monitors, core laboratories, CROs, consultants, etc. as appropriate to ensure safe, compliant and successful clinical trial conduct.

• Participates in driving quality awareness in every employee, while guiding the local organization towards improved performance and customer-oriented initiatives.

• Develops and implements an organized, continuous process for staff development in each level of the organization managed.

• Responsible for development of realistic clinical department budgets, schedules, and performance standards and directing the sub-functions for which responsible in accordance with these parameters.

• Interacts with senior level management concerning significant Clinical matters and clinical support functions to obtain services to support clinical objectives.

• Conducts briefings and technical meetings for senior management and clinical investigators as needed. Facilitates the sharing of scientific and clinical data across functional resources as required by the business.

• Analyzes, prepares and presents data from external/internal sources and partners with other functions such as Clinical Operations, Medical Affairs, Regulatory Affairs and Marketing to obtain regulatory product approvals.

• Develops and implements an organized, continuous process for staff development in line with departmental guidelines.

• Guides Clinical employees in support of following clinical trial management processes and procedures. Allocates/re-allocates internal and external technical resources, as needed utilizing in-house resource management tools

• Contributes to the development of corporate-wide clinical standards for content and quality of clinical trial data and documentation.

• Participates in internal and external audits as they occur. Reviews and approves corrective action plans at individual sites and across study.

• Drives policies and processes that incorporate innovative trends and practices in the field of clinical research.

• Working with the management team, guides and prepares the organization to proactively comply with regulatory agency decisions and changes in regulations.

• Ensures awareness and compliance with applicable standard operating procedures to meet, comply and champion all quality and regulatory commitments of Stryker.

• Participates in driving quality awareness in every employee, while guiding the local organization towards improved performance and customer-oriented initiatives.

• Co-ensures that employees are notified of all mandatory training and quality obligations with HR Manager. Creates training plans and tracks completion of mandatory training.

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), including at least 5 years in a managerial capacity managing clinical programs and clinical professionals/Program Managers in a cross functional product development setting. Business Process Improvement (BPI) experience strongly preferred.

• Leader with demonstrated success in building and fostering a culture of inclusion, collaboration and partnership and emphasizing engagement and development of direct and indirect reports.

• Professional with a deep understanding of governance associated with conducting clinical trials, including but not limited to experience in clinical evidence, medical affairs, scientific writing, and safety.

• Medical device (standalone or combination products) industry experience is required, with a strong preference for expertise in related areas such as coronary, peripheral, vascular, neurovascular and the like.

• Relationship-builder; skilled at engaging, building trust, influencing, and collaborating with internal cross-functional partners and a natural ability to connect and build rapport with physicians.

Competency Expectations:

• Excellent organizational and project management skills with a high sense of organization and attention to detail.

• Demonstrated success in developing clinical department infrastructure and designing and conducting clinical trials in support of medical device and/or pharmaceuticals.

• Demonstrated understanding of laws, regulations, standards, and guidance governing the conduct of clinical studies, as well as preparation of clinical documentation in support of regulatory submissions.

• Pro-active, energetic, self-assured professional with high personal integrity and ability to develop good interpersonal relationships with medical professionals and management at all levels of the NV organization.

• Analytical, strategic thinker with leadership ability and style that demonstrates professionalism and establishes respect.

• Excellent people management skills.

• Fluency in English, one additional language preferable.

• Excellent communication and presentation skills (articulate and persuasive).

• Excellent medical, technical and submission writing skills.

$145,700- $321,000 salary plus bonus eligible + generally eligible for short-term and long-term financial incentives + benefits.  Actual minimum and maximum may vary based on location.  Individual pay is based on skills, experience, and other relevant factors.