Drug Safety MD

Company Overview

A clinical stage biotech focused in the development and commercialization of first in it's kind CAR-T immunotherapies is seeking a Director MD Drug Safety to join their growing team.

Position Overview

The Medical Director will lead global pharmacovigilance for investigational products, overseeing safety surveillance, risk assessments, and managing the benefit-risk profile. The role involves working closely with cross-functional teams and ensuring accurate safety evaluations throughout the lifecycle of compounds, while reporting directly into the CMO.

Key Responsibilities:

• Lead safety surveillance, risk assessments, and safety management for assigned products.
• Perform medical review of adverse event reports and manage the safety data quality.
• Support decision-making through risk/benefit evaluations and medical data analysis.
• Collaborate with cross-functional teams on clinical trials, safety protocols, and patient safety issues.
• Develop and contribute to safety reports for regulatory submissions and periodic reports.
• Provide training and consultation on pharmacovigilance and drug safety processes.
• Participate in audits, inspections, and maintain compliance with global pharmacovigilance regulations.

Qualifications:

• MD from an accredited institution (board certification preferred).
• Oncology experience (solid, liquid, or cell therapy) required.
• Minimum of 5 years of pharmacovigilance experience in the biopharmaceutical industry.
• Expertise in safety data analysis, MedDRA coding, and global regulatory guidelines.
• Strong communication and organizational skills, with the ability to work in a fast-paced environment.
• Ability to collaborate with internal and external stakeholders to manage complex safety issues.