Job Description
We are looking for a highly experienced and passionate Director of Global Clinical Evidence & Medical Affairs to lead clinical evidence generation, scientific writing, physician engagement, and medical safety on a global scale. This is a fantastic opportunity to shape the future of clinical trials, support innovative medical research, and drive meaningful improvements in patient outcomes.
In this role, you will oversee the creation and maintenance of processes related to clinical study reports, regulatory-required reports, publications, and clinical presentations, while ensuring compliance with global regulations. You will also collaborate with cross-functional teams to maximize the use of clinical data, focusing on generating high-quality data and optimizing the efficiency of clinical processes.
Your leadership will play a crucial part in developing trial protocols, case report forms, and study reports, while ensuring safety protocols and clinical event assessments are properly managed and communicated. You will also be instrumental in guiding the organization's clinical policies and fostering strong relationships with physicians, clinical investigators, and external stakeholders to ensure successful clinical trials.
Key Responsibilities:
Clinical Leadership: Provide direction on all global clinical evidence generation, scientific writing, physician engagement, and medical safety, ensuring compliance with regulatory requirements.
Process Management: Oversee the development and management of clinical processes, including database generation, clinical report creation, medical coding, and regulatory reporting (CER/CES).
Clinical Studies Oversight: Lead the generation of essential clinical documents such as Clinical Study Reports, Summary of Safety & Clinical Performance reports, and Periodic Safety Update Reports.
Collaboration and Partnership: Foster strategic relationships with physicians, key opinion leaders, CROs, and other partners to ensure the successful and safe conduct of clinical trials.
Staff Development: Develop and implement a continuous process for staff development, ensuring all team members are aligned with organizational goals and objectives.
Regulatory Affairs: Collaborate with cross-functional teams (Clinical Operations, Medical Affairs, Regulatory Affairs, Marketing) to support regulatory product approvals and maintain compliance with industry standards.
Quality Assurance: Monitor and ensure quality standards across clinical processes, audits, and corrective actions as needed.
Innovative Practices: Drive policies and practices that incorporate innovative trends in clinical research to enhance the impact and success of clinical trials.
Education & Qualifications:
Required: Degree in a science or health-related field (e.g., Biology, Nursing, Biomedical Sciences, etc.) or equivalent experience. Alternatively, an MBA or equivalent business-focused degree is acceptable.
Experience: 12+ years of experience in clinical sciences within the medical industry (device, pharmaceutical, biotechnology), including at least 5 years in a managerial role overseeing clinical programs and professionals.
Industry Experience: Strong preference for experience in the medical device industry (especially in coronary, vascular, neurovascular, or similar areas).
Skills:
Proven leadership in clinical trial management and medical writing.
Experience managing clinical teams and fostering a culture of collaboration and inclusion.
Strong understanding of regulatory requirements, clinical documentation standards, and safety protocols.
Exceptional project management skills with a keen attention to detail.
Excellent communication, interpersonal, and presentation skills.
Compensation & Benefits:
Salary Range: $145,700 - $321,000 per year, plus bonus eligibility and short-term/long-term financial incentives.
Health Benefits: Medical, dental, and vision insurance, as well as critical illness, accident, and hospital indemnity insurance.
Financial Benefits: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), life insurance, and short-term disability insurance.
Additional Benefits: Personalized healthcare support, wellbeing programs, and tobacco cessation programs.
This role offers a chance to make a significant impact on the clinical research community and work alongside experts who are dedicated to advancing healthcare and improving patient outcomes. If you're a strategic thinker, an effective leader, and passionate about the medical industry, we would love to hear from you!
Employment Type: Full-Time
Salary: $ 146,000.00 321,000.00 Per Year
Job Tags
Full time, Temporary work, Remote job, Flexible hours,