Senior Director, Safety Scientist

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Parabilis Medicines

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2016

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Parabilis Medicines is focused on creating extraordinary medicines through its innovative Helicon™ peptide platform. The company aims to advance a new category of ultra-tunable peptide therapeutics designed to transform treatment possibilities for patients suffering from severe diseases, particularly cancer. By prioritizing groundbreaking changes in medicine rather than incremental improvements, Parabilis strives to have a life-changing impact on patients and their communities.

📋 Description

• Provide scientific leadership for safety surveillance and risk management across the clinical development portfolio. • Lead safety science activities for assigned development programs and provide strategic input into benefit-risk assessment. • Author and maintain Safety Surveillance Plans (SSPs). • Perform signal detection and signal management activities, including maintenance of the signal tracker. • Contribute to literature surveillance to identify, evaluate, and communicate potential safety signals. • Perform MedDRA SMQ and Preferred Term searches for adverse events of clinical interest. • Partner with internal stakeholders to use visualization tools such as Spotfire for safety signal detection and analysis. • Author Signal Analysis Reports (SARs) for validated signals and support risk characterization and mitigation strategies. • Prepare presentations for Drug Safety Monitoring Team meetings. • Develop scientific materials for safety-focused advisory boards and Key Opinion Leader meetings. • Author and maintain Development Risk Management Plans (dRMPs) and Development Core Safety Information (DCSI). • Contribute safety expertise to Investigator’s Brochures, clinical protocols, informed consent forms, DSURs, and other regulatory documents. • Contribute to PV dashboards and ensure timely communication of relevant safety science information. • Author and update Safety Science SOPs, work instructions, and signal/risk management procedures. • Support safety-related responses to health authorities, IRBs/ECs, and Clinical Trial Applications. • Collaborate cross-functionally to integrate safety insights into clinical development strategy, regulatory submissions, and key program decisions while improving safety science processes. • Report to the VP, Head of Clinical Safety & Pharmacovigilance.

🎯 Requirements

• Advanced degree in Life Sciences, Pharmacy, Nursing, Medicine (PharmD, Ph.D.) required; MDs will also be considered. • 12+ years of experience in pharmacovigilance, drug safety, or safety science within the biotechnology or pharmaceutical industry. • Significant experience supporting clinical-stage development programs. • Expertise in safety surveillance, signal detection and management, benefit-risk assessment, and safety risk management across multiple clinical development phases. • Experience authoring SSPs, SARs, dRMPs, DCSI, IBs, DSURs, clinical protocols, and informed consent forms. • Experience supporting regulatory interactions and preparing responses to global health authorities on safety topics. • Strong working knowledge of global pharmacovigilance regulations and guidance, including FDA, EMA, and ICH requirements. • Experience with safety databases, MedDRA coding, SMQs, and safety data visualization and analytics tools such as Spotfire. • Ability to lead complex cross-functional initiatives and influence decision-making without direct authority in a highly matrixed organization. • Prior experience in oncology, rare disease, immunology, or other specialty therapeutic areas preferred. • Baseline proficiency using AI tools for day-to-day work; advanced or innovative AI use is a strong plus.

🏖️ Benefits

• Annual target bonus • Equity • Comprehensive suite of competitive benefits designed to support employees’ overall well-being