Senior Director, Inspection Readiness

🕒 il y a 1 mois

🇺🇸 États-Unis – Télétravail

💵 $250 000 - $325 000 / an

⏰ Temps Plein

🟠 Senior

👔 Directeur

👻 Score fantôme 5%

Ce que ça veut dire : la probabilité que personne ne recrute vraiment pour cette offre.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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Absci

Site WebLinkedInTous les Emplois

51 - 200 employés

Fondée en 2011

🧬 Biotechnologie

🤖 Intelligence artificielle

💊 Pharmaceutique

Biotechnology • Artificial Intelligence • Pharmaceuticals

Absci est une entreprise de biotechnologie qui utilise l'intelligence artificielle générative combinée à la validation en laboratoire humide pour concevoir de novo des biologiques, principalement des anticorps. Sa plateforme intégrée de création de médicaments par IA effectue la génération de données, l'entraînement de modèles, la conception de novo, l'optimisation de candidats multi-paramétriques, et la découverte de cibles assistée par IA (en utilisant l'immunologie inverse) pour découvrir de nouvelles paires anticorps/cibles et accélérer les études permettant de soutenir les demandes d'IND. Absci fait progresser des programmes thérapeutiques internes et en partenariat, tels que l'ABS-201, un anticorps conçu ciblant les récepteurs de la prolactine pour l'alopécie androgénétique, et met l'accent sur les cycles itératifs rapides entre l'IA et le travail de laboratoire pour raccourcir les délais de découverte de biologiques.

Description

• Provide Sponsor-level leadership for inspection readiness and GCP compliance across clinical studies, programs, and functional areas • Develop, implement, and maintain a risk-based inspection readiness framework • Assess clinical study and operational-process readiness, including documentation, Sponsor oversight, issue management, data integrity, and regulatory adherence • Identify compliance, process, documentation, and oversight gaps and drive remediation and preventive actions • Oversee clinical trial registration and results-reporting requirements, including ClinicalTrials.gov • Track reporting requirements, accountabilities, timelines, supporting documentation, and compliance evidence • Assess clinical development training requirements and training matrices • Review and improve SOPs, work instructions, plans, templates, and controlled documents • Support development, implementation, training, and adoption of new or revised processes • Partner with Data Management/Biometrics and cross-functional teams on operational quality, data integrity, issue resolution, and database-lock readiness • Support inspection-ready Trial Master Files and essential records • Evaluate CRO and vendor oversight practices and documentation • Establish inspection-readiness metrics, dashboards, risk indicators, and management routines • Lead or coordinate mock inspections, gap assessments, and targeted deep dives • Support regulatory inspections and Sponsor audits, including planning, document readiness, interview preparation, response coordination, and remediation • Partner with Quality to align Clinical Operations execution with the Quality Management System • Monitor evolving ICH-GCP expectations, regulations, inspection trends, and industry best practices • Promote quality, accountability, operational discipline, continuous improvement, and proactive inspection readiness • Provide senior-level coaching and guidance on GCP compliance, inspection readiness, documentation, and operational excellence • Support strategic initiatives across Global Clinical Operations and the broader development organization • Travel domestically and internationally up to 20–30% as required

🎯 Exigences

• Bachelor’s degree in life sciences or a related field • 15+ years of clinical operations, clinical quality, or related drug-development experience • Substantial direct experience in global clinical trial execution and inspection readiness • Deep knowledge of ICH-GCP, Sponsor responsibilities, applicable clinical trial regulations, quality systems, and regulatory inspection expectations • Experience preparing for and supporting regulatory inspections, Sponsor audits, mock inspections, and inspection-readiness assessments • Strong understanding of end-to-end clinical trial operations across study start-up, conduct, monitoring, data management, safety interfaces, TMF, CRO/vendor oversight, database lock, closeout, and reporting • Experience with clinical trial registration and results disclosure requirements, including ClinicalTrials.gov • Experience reviewing, developing, or improving SOPs, work instructions, controlled documents, training requirements, and operational processes • Experience assessing and remediating cross-functional compliance and operational gaps • Strong knowledge of TMF requirements and inspection-ready documentation practices • Experience partnering with Data Management/Biometrics, Regulatory, Quality, Clinical Development, Safety, and other functions • Strong CRO and vendor oversight experience • Ability to operate effectively in a small, fast-paced, growth-oriented biotechnology or pharmaceutical environment • Strong cross-functional leadership and ability to influence senior stakeholders and drive accountability without direct authority • Excellent written and verbal communication skills, executive presence, sound judgment, and ability to communicate complex compliance and operational issues clearly and pragmatically • Highly analytical, detail- and process-oriented, with strong project management, problem-solving, prioritization, and follow-through • Legal authorization to work in the United States

🏖️ Avantages

• Medical insurance • Dental insurance • Paid time off • 401(k) with a generous company match • Equity • Bonus

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