Senior Director, Safety Scientist

🕒 il y a 1 mois

🇺🇸 États-Unis – Télétravail

💵 $255 000 - $300 000 / an

⏰ Temps Plein

🟠 Senior

👔 Directeur

👻 Score fantôme 0%

Ce que ça veut dire : la probabilité que cette offre reste ouverte sans recrutement actif.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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Parabilis Medicines

Site WebLinkedInTous les Emplois

51 - 200 employés

Fondée en 2016

🏥 Santé

🧬 Biotechnologie

💊 Pharmaceutique

Healthcare • Biotechnology • Pharmaceuticals

Parabilis Medicines se concentre sur la création de médicaments extraordinaires grâce à sa plateforme innovante Helicon™ de peptides. L'entreprise vise à faire progresser une nouvelle catégorie de thérapeutiques peptidiques ultra-réglables conçues pour transformer les possibilités de traitement pour les patients souffrant de maladies graves, en particulier le cancer. En privilégiant les changements révolutionnaires en médecine plutôt que les améliorations progressives, Parabilis s'efforce d'avoir un impact transformateur sur les patients et leurs communautés.

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.

🎯 Exigences

• 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.

🏖️ Avantages

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