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.