Director, Global Clinical Evidence & Medical Affairs

$145,700 - $321,000/Yr

Stryker - Texas, AL

Full-time - Senior

Texas, AL

Miscellaneous Manufacturing

About the position

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.

Responsibilities

• Provides direction on all global clinical evidence generation, scientific writing, physician engagement and medical safety.
• Manages all processes utilized by the Biostatistics and Data Management organization related to trial database generation, management, report generation, programming, medical coding.
• Oversees all processes related to CER/CES generation for MDR, NMPA and other global regulators.
• Manages all processes that lead to or rely on Medical Writing including Clinical Study reports, regulatory-required annual reports, and Summary of Safety & Clinical Performance.
• Oversees reports needed for secondary regulatory approvals beyond US, Japan, China and Europe.
• Manages all electronic systems, tools, databases, templates utilized for Biostats and Data Management.
• Oversees processes related to the presentation and/or publication of NV-related clinical information.
• Manages the Medical Writing and Advance Evidence groups focusing on research supporting past, current and future trials.
• 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.
• 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.
• 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.
• Creates training plans and tracks completion of mandatory training.

Requirements

• Degree in science/health related field (e.g., Biology, Nursing, Biomedical or Veterinary Sciences) preferred.
• Alternatively, degree in Business, MBA, Program Management or equivalent.
• 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.
• Business Process Improvement (BPI) experience strongly preferred.
• Deep understanding of governance associated with conducting clinical trials.
• Medical device industry experience required, with expertise in areas such as coronary, peripheral, vascular, neurovascular.
• Skilled at engaging, building trust, influencing, and collaborating with internal cross-functional partners.

Nice-to-haves

• Fluency in English, one additional language preferable.
• Excellent communication and presentation skills.
• Excellent medical, technical and submission writing skills.

Benefits

• $145,700- $321,000 salary plus bonus eligible.
• Generally eligible for short-term and long-term financial incentives.
• Benefits package.