Associate Medical Director

Overview

• Provide medical oversight for clinical trials ensuring adherence to SOPs, regulatory requirements, and good clinical practices.
• Offer medical consultation to clients, investigators, and project teams, supporting business development activities.
• Review and analyze clinical trial serious adverse events, periodic safety reports, and other client deliverables.
• Ensure proper execution of tasks delegated to the pharmacovigilance group (PVG).
• Provide therapeutic and protocol training for assigned studies as requested.
• Monitor safety variables and discuss medical concerns with investigators and clients.
• Perform data reviews to assess potential safety concerns and ensure compliance.
• Support risk management activities, label updates, and dossier maintenance for marketed products.

Key Responsibilities & Duties

• Manage medical aspects of contracted tasks across the pharmaceutical product lifecycle.
• Ensure adherence to regulations, ICH guidelines, and client SOPs for assigned projects.
• Provide medical review of adverse events and clinical outcomes reported by study sites.
• Perform signal detection activities and scientifically review aggregate reports.
• Contribute to the development and review of clinical trial documentation and reports.
• Collaborate with teams to ensure accurate and complete medical content in deliverables.
• Act as a mentor and trainer to other staff, promoting knowledge sharing.
• Participate in investigator and sponsor meetings, presenting medical insights.

Job Requirements

• Doctor of Medicine (MD) with board certification in Rheumatology.
• Minimum 2 years of clinical experience or equivalent in clinical trials or pharmacovigilance.
• Proficiency in safety databases, biostatistics, and clinical operations procedures.
• Strong decision-making, problem-solving, and analytical skills.
• Excellent communication skills in English, both written and spoken.
• Flexibility to travel domestically and internationally as needed.
• Ability to work independently and prioritize sensitive, complex information.
• Understanding of FDA, ICH, EMA, and GCP guidelines.