Director/Sr Medical Director, Medical Safety Evaluation, Immunology - Remote

Overview

The Director/Sr Medical Director will serve as the Indication Product Safety Lead, providing safety expertise throughout the lifecycle of pharmaceutical products, ensuring compliance with regulatory guidelines.

In Short

• Lead safety surveillance for pharmaceutical and biological products.
• Author key safety documents and regulatory submissions.
• Analyze and summarize aggregate safety data.
• Collaborate with cross-functional teams and senior management.
• Define risk management strategies for assigned products.
• Mentor and coach team members.
• Co-author publications and enhance safety leadership.
• Utilize pharmacology and toxicology knowledge in safety assessments.
• Engage in continuous improvement of safety processes.
• Participate in long-term incentive programs.

Requirements

• MD/DO with residency and patient management experience.
• 5-8 years in Pharmacovigilance or Clinical Development.
• Strong analytical skills in clinical data and epidemiology.
• Excellent communication skills for presenting findings.
• Ability to lead cross-functional teams.
• Proficient in writing and reviewing technical documents.
• Independent decision-making capabilities.

Benefits

• Comprehensive benefits package including medical, dental, and vision insurance.
• Paid time off including vacation and holidays.
• Participation in short-term and long-term incentive programs.