Director, Medical Safety Lead - DSPV, Gene Therapy

Insmed Incorporated; United States; On-site; USD 180,000 - 240,000; Full time

Job summary

Scorpion Therapeutics is seeking a Director, Medical Safety Lead for DSPV Gene Therapy to oversee safety surveillance, risk management, and cross-functional safety input. The role focuses on evaluating safety data from multiple sources and guiding risk strategies through regulatory interactions.

The candidate will lead safety review teams, contribute to development documents, and ensure robust safety documentation across product life cycles, with remote work and occasional domestic travel.

Qualifications

• MD or DO with 5+ years in drug safety/pharmacovigilance.
• Experience with clinical and post-marketing safety data.
• Regulatory guidelines knowledge.
• Excellent communication skills.

Responsibilities

• Oversee safety surveillance and risk management for gene therapy products.
• Lead safety review teams and contribute to regulatory and development documents.
• Develop risk management strategies and provide expert safety input across functions.
• Support regulatory interactions and safety documentation.

Skills

Pharmacovigilance

Safety data review

Regulatory guidelines

Communication skills

Leadership experience

Education

MD/DO

MPH

Tools

Database expertise

Job description

Role: Director, Medical Safety Lead - DSPV Gene Therapy, responsible for safety surveillance, risk management, and communication for gene therapy products.

Core responsibilities include evaluating safety data from multiple sources, leading safety review teams, contributing to regulatory and development documents, developing risk management strategies, and providing expert safety input across functions.

Qualifications

• MD or DO with 5+ years in drug safety/pharmacovigilance
• experience with clinical and post-marketing safety data
• regulatory guidelines knowledge
• excellent communication skills

Preferred

• MPH
• clinical care experience
• gene therapy or database expertise
• product defense experience

High-value specifics

• gene therapy modality
• safety data review from preclinical to post-marketing
• involvement in benefit-risk assessments
• safety documentation
• regulatory interactions

Work setup

fully remote, with occasional domestic travel (~20%).