Meet has partnered with a pioneering biopharmaceutical company dedicated to advancing innovative treatments for psychiatric and neurodegenerative disorders. Their mission is to improve the quality of life for patients by developing cutting-edge therapies and conducting groundbreaking research. As they continue to grow and expand our impact, we are seeking a highly experienced and motivated Senior Medical Director Or Executive Medical Director to lead our Safety and Pharmacovigilance efforts.
Position Overview:
As the Senior Medical Director of Safety and Pharmacovigilance, you will play a crucial role in ensuring the safety and efficacy of our therapeutic products throughout their lifecycle. You will lead a team of experts in monitoring and assessing the safety profile of our drugs, ensuring compliance with regulatory requirements, and guiding strategic decisions to mitigate risks and enhance patient safety.
Key Responsibilities:
- Leadership and Strategy: Provide strategic leadership in the development and execution of safety and pharmacovigilance strategies. Oversee the safety assessment of clinical trials and post-marketing activities, ensuring alignment with regulatory guidelines and industry best practices.
- Safety Monitoring: Direct the evaluation of safety data from clinical trials and real-world use. Lead the development and implementation of risk management plans and strategies to identify, assess, and minimize potential safety concerns.
- Regulatory Compliance: Ensure compliance with global regulatory requirements and standards related to drug safety. Prepare and review safety reports, including Periodic Safety Update Reports (PSURs), Risk Evaluation and Mitigation Strategies (REMS), and other regulatory submissions.
- Cross-Functional Collaboration: Work closely with Clinical Development, Medical Affairs, Regulatory Affairs, and other internal teams to integrate safety considerations into clinical development programs and strategic decision-making processes.
- Team Management: Lead, mentor, and develop a high-performing team of safety and pharmacovigilance professionals. Foster a collaborative and innovative work environment that encourages continuous improvement and professional growth.
- External Engagement: Represent the company in interactions with regulatory agencies, clinical investigators, and other external stakeholders. Provide expert guidance and support in safety-related inquiries and inspections.
Qualifications:
- Medical Degree (MD or equivalent) required. Advanced degrees or additional qualifications in clinical pharmacology, toxicology, or related fields are highly desirable.
- Extensive Experience: Minimum of 10 years of experience in drug safety and pharmacovigilance, with at least 5 years in a leadership role. Proven experience in managing safety for clinical trials and marketed products, preferably in the context of psychiatric or neurodegenerative disorders.
- Regulatory Knowledge: Deep understanding of global regulatory requirements and guidelines related to drug safety, including ICH, FDA, EMA, and other international standards.
- Leadership Skills: Strong leadership abilities with a track record of successfully managing and developing teams. Excellent interpersonal and communication skills, with the ability to collaborate effectively with cross-functional teams and external partners.
- Analytical Expertise: Demonstrated ability to analyze complex safety data, identify trends, and make informed decisions to address safety concerns.
- Innovation and Problem-Solving: Proven ability to think strategically and creatively to solve complex problems and drive the development of innovative safety solutions.
