Director, Medical Safety Lead - DSPV Gene Therapy

TL;DR

Director, Medical Safety Lead - DSPV Gene Therapy: Safety surveillance, risk management, and communication for gene therapy products and development compounds with an accent on signal detection, benefit-risk assessment, and regulatory documentation. Focus on leading safety review teams, providing expert input to clinical and regulatory documents, and collaborating across functions to ensure accurate safety profiles.

Location: Fully remote from anywhere. Occasional domestic travel (up to 20%) for team meetings or events may be expected.

Salary: $247,000–$337,000 Annual

Company

Global biopharmaceutical company focused on serious and rare diseases, recognized as Science magazine’s No. 1 Top Employer.

What you will do

• Review safety data from pre-clinical, clinical, post-marketing, and literature sources for assigned products.
• Conduct signal detection, monitoring, evaluation, and management of safety information.
• Lead Safety Review Teams, assess benefit-risk profiles, and update related documents.
• Provide medical safety input to clinical development documents like protocols, ICFs, IBs, and regulatory submissions.
• Develop safety and risk management strategies, including RMPs and REMS.
• Collaborate with global teams in Clinical Development, Regulatory Affairs, and others on safety matters.

Requirements

• MD or DO with 5+ years in Drug Safety/Pharmacovigilance in pharma across investigational and marketed products.
• Experience reviewing and preparing scientific/regulatory documents from large data volumes.
• Knowledge of national and international Pharmacovigilance and regulatory guidelines.
• Experience presenting drug safety topics to authorities or at meetings.
• Strong verbal and written communication, organizational skills, and attention to detail.
• Ability to thrive in dynamic, culturally diverse environments.

Nice to have

• Master of Public Health (MPH).
• 2+ years clinical patient care experience.
• Drug safety database knowledge.
• Experience with gene therapy products.
• Product defense before regulatory authorities.

Culture & Benefits

• Comprehensive medical, dental, vision, mental health support, wellbeing reimbursement, and EAP.
• Generous PTO, fertility/family benefits, caregiver support, flexible schedules.
• 401(k) with company match, equity awards, ESPP, company-paid life/disability insurance.
• Learning Institute with LinkedIn Learning, workshops, leadership programs, mentorship.
• Employee resource groups, recognition programs, volunteering opportunities.