We are seeking a highly skilled and experienced Medical Director to provide leadership in the oversight of clinical studies and drug safety operations in the United States. The successful candidate will be responsible for ensuring the highest standards of subject safety, medical compliance with protocols and ICH-GCP requirements, and maintaining the scientific integrity and quality of clinical studies. In addition, this role requires leading the day-to-day Drug Safety function with a primary focus on providing medical and safety support for both investigational and marketed products, ensuring compliance with all relevant regulations and guidelines.

Responsibilities:

Clinical Studies:

• Provide medical oversight for all clinical studies conducted in the US, ensuring compliance with regulatory requirements, protocols, and ICH-GCP guidelines.
• Monitor and ensure the safety and well-being of study participants by reviewing and evaluating safety data, adverse event reports, and protocol deviations.
• Collaborate with cross-functional teams to develop and implement medical monitoring plans, study protocols, and safety management plans.
• Conduct medical review of study data, clinical trial reports, and other relevant documentation to ensure the scientific integrity and quality of clinical studies.
• Serve as the primary point of contact for site investigators and medical monitors, providing medical guidance and support as needed.
• Lead the development and implementation of risk management strategies to proactively address potential safety concerns and ensure subject safety throughout the duration of clinical studies.

Drug Safety:

• Oversee the day-to-day operations of the Drug Safety function, ensuring compliance with regulatory requirements and industry best practices.
• Lead the preparation and timely submission of expedited and periodic safety reports for both investigational and marketed products, adhering to relevant regulatory guidelines and requirements.
• Provide medical expertise and guidance in the review and analysis of safety data, including adverse events, serious adverse events, and other safety-related information.
• Collaborate with cross-functional teams, including pharmacovigilance, regulatory affairs, and clinical operations, to address safety-related issues and implement appropriate risk management strategies.
• Stay updated on relevant regulatory changes and guidelines related to drug safety and pharmacovigilance, and ensure organizational compliance with all applicable regulations and requirements.

Requirements:

• Medical degree (MD or equivalent) with active medical license in the US.
• Board certification in a relevant medical specialty is preferred.
• Minimum of 5 years of experience in medical oversight of clinical studies, with a strong understanding of GCP guidelines and regulatory requirements.
• Proven experience in leading and managing drug safety operations, including the preparation and submission of safety reports for both investigational and marketed products.
• In-depth knowledge of pharmacovigilance practices, risk management strategies, and safety assessment methodologies.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and external stakeholders.
• Strong leadership and decision-making abilities, with a demonstrated track record of effectively leading and developing high-performing teams.
• Detail-oriented with strong analytical and problem-solving skills, and the ability to make data-driven decisions to ensure the safety and integrity of clinical studies.