Senior Director, Safety Scientist

About the Company

Parabilis Medicines is a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines for patients with serious diseases by unlocking biologically important targets long considered undruggable. The company has pioneered a new class of alpha-helical peptides – Helicons™ – capable of modulating intracellular proteins that have historically been beyond the reach of conventional medicines.

Responsibilities

• Lead safety science activities for assigned development programs and provide strategic input into benefit-risk assessment
• Author and maintain Safety Surveillance Plans (SSPs), Development Risk Management Plans (dRMPs), and Development Core Safety Information (DCSI)
• Perform signal detection and management activities, including maintenance of the signal tracker
• Contribute to literature surveillance to identify and evaluate potential safety signals
• Perform MedDRA SMQ and Preferred Term searches for adverse events of clinical interest
• Partner with internal stakeholders to leverage visualization tools like Spotfire for safety analysis
• Author Signal Analysis Reports (SARs) and support risk characterization and mitigation strategies
• Prepare presentations for Drug Safety Monitoring Team (DSMT) meetings
• Develop scientific materials for safety-focused advisory boards and Key Opinion Leader (KOL) meetings
• Contribute safety expertise to Investigator's Brochures, clinical protocols, informed consent forms, and DSURs
• Support safety-related responses to health authorities, IRBs/ECs, and Clinical Trial Applications (CTAs)

Requirements

• Advanced degree in Life Sciences, Pharmacy, Nursing, or Medicine (PharmD, Ph.D., or MD)
• 12+ years of experience in pharmacovigilance, drug safety, or safety science in biotech or pharma
• Expertise in safety surveillance, signal detection, and benefit-risk assessment across clinical phases
• Experience authoring SSPs, SARs, dRMPs, DCSI, IBs, and DSURs
• Experience supporting regulatory interactions with global health authorities (FDA, EMA, ICH)
• Proficiency with safety databases, MedDRA coding, SMQs, and data visualization tools like Spotfire
• Ability to lead complex cross-functional initiatives in a matrixed organization
• Proficiency with AI tools for day-to-day work tasks

Preferred Qualifications

• Prior experience in oncology, rare disease, or immunology