Associate Director, Drug Safety and Pharmacovigilance

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Celcuity

WebsiteLinkedInAlle Stellen

51 - 200 Mitarbeiter

🧬 Biotechnologie

💊 Pharmazie

🔥 Finanzierung im letzten Jahr

💰 €500.000.000 Post-IPO Debt - Celcuity im 2025-09

Biotechnology • Pharmaceuticals

Celcuity ist ein biopharmazeutisches Unternehmen in der klinischen Entwicklungsphase, das zielgerichtete Therapien entwickelt, die den PI3K/AKT/mTOR (PAM) Signalweg umfassend blockieren, um mehrere solide Tumoren zu behandeln. Sein führender Produktkandidat, Gedatolisib, ist ein potenzieller first-in-class Pan-PI3K und mTORC1/2 Hemmer in der späten klinischen Entwicklung (einschließlich der Phase-3 VIKTORIA-Studien) für HR+/HER2- fortgeschrittenen Brustkrebs und andere Indikationen wie Prostatakrebs. Das Unternehmen fördert eine fokussierte Pipeline von PAM-Signalwegsinhibitoren, veröffentlicht klinische Daten, engagiert sich mit Investoren und Regulierungsbehörden und ist missionarisch darauf ausgerichtet, die Behandlungsergebnisse für Krebspatienten zu verbessern.

Beschreibung

• Provide leadership and oversight of external safety vendors to ensure high‑quality, timely, and compliant execution of all outsourced safety activities. • Lead the preparation, authorship, and review of aggregate safety reports (e.g., DSURs, PADERs, line listings) and manage associated timelines and cross‑functional inputs. • Provide day-to-day direction to the Safety Operations team and communicate program-level updates to internal and external stakeholders. • Demonstrate initiative by exploring potential solutions and offering thoughtful recommendations, engaging leadership when additional insight or alignment is needed. • Oversee the review and assessment of adverse event reports for assigned programs, ensuring appropriate follow‑up and timely expedited reporting in accordance with global regulatory requirements. • Contribute to the development, implementation, and continuous improvement of SOPs, work instructions, templates, and systems to ensure compliance with global clinical trial regulations and industry best practices. • Ensure procedural deviations are documented, investigated, and addressed through effective corrective and preventive actions. • Support inspection readiness activities and serve as a key contributor during audits and global health authority inspections. • Develop and maintain study‑specific safety management plans and related documents, ensuring clear delineation of responsibilities between Celcuity and CRO partners. • Ensure adherence to Safety Data Exchange Agreements and compliance with all agreed‑upon reporting requirements and timelines. • Review and provide expert input on safety-related sections of clinical documents, including protocols, charters, Investigator Brochures, and Informed Consent Forms. • Develop, monitor, and interpret key performance indicators and metrics for internal teams and external vendors to evaluate performance and drive continuous improvement. • Serve as the safety subject matter expert for internal teams and external stakeholders, providing guidance on safety operations, regulatory expectations, and best practices. • Perform other tasks as required to assist in company and departmental activities.

🎯 Anforderungen

• 10+ years of drug safety/pharmacovigilance experience within a sponsor environment or a combination of sponsor and CRO roles. • Bachelor’s or advanced degree in a life science or healthcare‑related discipline (e.g., MD, RN, PharmD, NP, PhD, MPH). • Comprehensive knowledge of global clinical safety regulations, guidelines, and industry best practices. • Extensive experience working with commercial safety databases (Argus or ARIS-G), electronic data capture systems, and trial master files. • Demonstrated experience preparing aggregate safety reports for investigational and/or marketed products (e.g., DSURs, PSUR/PBRERs, PADERs) and contributing to IB updates. • Strong knowledge of MedDRA and WHODrug coding conventions. • Excellent written and verbal communication skills, with the ability to convey complex information clearly and concisely. • Strong interpersonal skills with the ability to collaborate effectively across functions and organizational levels. • Exceptional attention to detail and ability to manage multiple priorities and documentation requirements. • Strong technical and analytical skills with advanced proficiency in MS Office (Word, Excel, PowerPoint). • Ability to work independently or collaboratively, demonstrating sound judgment and decision‑making in a fast‑paced environment. • Naturally takes initiative, contributing to continuous improvement efforts and proactively identifying opportunities to enhance processes within the department. • Continuous improvement mindset with a focus on innovation, efficiency, and operational excellence. • Flexible, adaptable, and committed to maintaining a positive and professional demeanor.

🏖️ Vorteile

• Medical insurance • Dental insurance • Vision insurance • 401(k) match • PTO • Paid holidays • Annual performance incentive bonus • New hire equity package