Medical Director, Drug Safety

Discover an exciting opportunity to shape the future of targeted cancer and inflammatory disease therapies with a leading biopharmaceutical company at the forefront of innovative drug design. In this role, you will have the chance to impact patient lives directly by guiding safety strategies and ensuring the highest standards of clinical safety across groundbreaking therapies. If you're passionate about combining clinical expertise with cutting-edge science in a dynamic environment, this position offers a unique platform to make a difference.

Our client is a clinical-stage biopharmaceutical company dedicated to developing targeted protein degradation medicines, harnessing advanced AI technologies and expert ligase capabilities. Their focus is on translating science into meaningful clinical advancements, positioning their therapies at the forefront of patient care.

As a Medical Director of Drug Safety, you will play a vital role in safeguarding patient well-being during the clinical development of innovative therapies. You will work closely with cross-functional teams, including clinical development and regulatory affairs, to interpret safety data, guide benefit-risk assessments, and develop comprehensive pharmacovigilance strategies. This position provides a meaningful impact on the organization’s development pipeline and the ultimate success of their treatments.

Key Responsibilities

• Lead medical safety initiatives for assigned products, providing clinical guidance on safety strategy and activities.
• Conduct aggregate safety data analysis to detect and evaluate safety signals and characterize risks.
• Review safety data, contributing to benefit–risk assessments that inform critical development decisions.
• Monitor emerging safety signals, proactively addressing potential risks through strategic communication.
• Support regulatory interactions by preparing safety reports and contributing to safety documentation, including DSURs and regulatory submissions.
• Provide clinical insights into safety considerations for trial protocols, informed consent forms, and investigator materials.
• Participate in safety governance committees, supporting strategic risk mitigation and benefit–risk evaluations.

Experience & Requirements

• MD degree with clinical experience preferred.
• 10+ years of pharmacovigilance or drug safety experience within the pharmaceutical or biotech industry.
• Expertise in aggregate safety analysis, benefit–risk evaluation, and global pharmacovigilance regulations (ICH, FDA, EMA, MHRA).
• Proven track record supporting clinical development, regulatory submissions, and post-marketing safety surveillance.
• Strong communication and leadership skills with the ability to interpret complex safety data.

This role offers a base salary between $320,000 and $350,000, depending on experience.