Senior Executive Director, Pharmacovigilance

Emploi pas sur LinkedIn

🕒 il y a 27 jours

🇺🇸 États-Unis – Télétravail

💵 $250 000 - $330 000 / 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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Jade Biosciences

Site WebLinkedInTous les Emplois

11 - 50 employés

Fondée en 2024

🏥 Santé

🏭 Fabrication

🧬 Biotechnologie

Healthcare • Manufacturing • Biotechnology

Jade Biosciences est une entreprise de biotechnologie en phase clinique qui développe des thérapies potentiellement de pointe visant à transformer le standard de soin des maladies auto-immunes. Son candidat principal, JADE101, est un anticorps conçu pour inhiber la cytokine APRIL (A PRoliferation-Inducing Ligand) et est en cours de développement pour le traitement de la néphropathie à immunoglobuline A (IgAN). La société construit son portefeuille à partir de produits en phase de découverte sous licence de Paragon Therapeutics et se concentre sur l'avancement des programmes cliniques afin d'offrir de nouveaux traitements aux patients atteints de maladies auto-immunes.

Description

• Serve as Head of Pharmacovigilance, accountable for safety strategy, safety science, and PV operations across the portfolio • Report to the Chief Medical Officer • Build a fit-for-purpose, inspection-ready PV function that scales with JADE101 global Phase 3 development and JADE201/JADE301 early development • Establish safety governance and signal management frameworks • Oversee outsourced PV vendors and author or review key safety deliverables • Partner with Clinical Development, Regulatory Affairs, Clinical Operations, Biometrics, Quality, and Program Management • Ensure timely, compliant expedited and periodic reporting, including SUSARs, IND safety reports, and DSURs, to FDA, EMA, and other health authorities • Author or provide senior review of safety content for protocols, Investigator’s Brochures, informed consent forms, clinical study reports, and health authority responses • Support global expansion, including Japanese and Chinese regulatory interactions and multi-region Phase 3 execution • Oversee safety database management, case processing, reconciliation, literature screening, and submissions • Own vendor KPIs, quality metrics, PV budget, and resourcing model • Negotiate and implement safety data exchange agreements with partners, licensors, and CROs • Build and maintain PV quality systems, SOPs, work instructions, training curricula, and PV system master file • Ensure GVP/GCP compliance and lead PV inspection- and audit-readiness activities with Quality Assurance • Identify and close process gaps during transition from early- to late-stage development • Hire, mentor, and develop PV staff and consultants; establish scalable processes and a culture of scientific rigor and accountability

🎯 Exigences

• Bachelor’s degree with 10–15 years of industry experience • Minimum of 10 years of pharmacovigilance/drug safety experience in the biopharmaceutical industry • Progressive leadership responsibility; Executive Director level requires broader scope and prior head-of-function experience • Demonstrated experience as head of PV or deputy in a development-stage company • Experience building fit-for-purpose PV processes and quality systems • Deep working knowledge of global PV regulations and guidance, including 21 CFR, ICH E2A/E2B/E2C/E2D/E2F, and EU GVP modules • Knowledge of expedited and aggregate reporting requirements • Experience selecting and overseeing PV vendors, safety databases such as Argus, and outsourced case processing operations • Experience supporting FDA and/or EMA health authority inspections and client/sponsor audits with successful outcomes • Excellent scientific judgment, written and verbal communication, and cross-functional collaboration skills • Preferred: 10 years of experience with biologics/monoclonal antibodies and immunology, rheumatology, nephrology, or rare disease programs • Preferred: Experience supporting late-stage global development and BLA/MAA safety deliverables, including risk management plans • Preferred: Familiarity with safety data visualization and analytics tools for signal detection • Preferred: Experience integrating PV requirements across licensing/partnering relationships • Preferred: Prior experience scaling a PV function from first-in-human through Phase 3 and toward marketing authorization • Authorization to work in the United States as verified through I-9 and E-Verify

🏖️ Avantages

• Remote work arrangement • Periodic travel to team and company events