Senior Director, Inspection Readiness

🕒 vor 1 Monat

🇺🇸 Vereinigte Staaten – Remote

💵 $250.000 - $325.000 / Jahr

⏰ Vollzeit

🟠 Senior

👔 Direktor

👻 Geisterscore 7%

Was es bedeutet: die Wahrscheinlichkeit, dass für diese Stelle niemand wirklich einstellt.So liest du es: 60 % oder höher heißt, wir halten das für einen Geisterjob. Niedrigere Werte sind weniger bedenklich.Wie wir werten: Dauer offen, Neuveröffentlichungen, offene Stellen vs Teamgröße, wie schnell Stellen geschlossen werden, und ob ein Gehalt angegeben ist.Hinweis: eine Schätzung aus öffentlichen Daten, kein Urteil über das Unternehmen. Echte Stellen können hoch punkten, nutze es also als Hinweis, nicht als Fakt.

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Absci

WebsiteLinkedInAlle Stellen

51 - 200 Mitarbeiter

Gegründet 2011

🧬 Biotechnologie

🤖 Künstliche Intelligenz

💊 Pharmazie

Biotechnology • Artificial Intelligence • Pharmaceuticals

Absci ist ein Biotechnologieunternehmen, das generative künstliche Intelligenz zusammen mit der Validierung im Nasslabor einsetzt, um de-novo-Biologika, hauptsächlich Antikörper, zu entwerfen. Ihre integrierte KI-Drug-Creation-Plattform führt Datengenerierung, Modelltraining, de-novo-Design, multiparametrische Lead-Optimierung und KI-unterstützte Zielentdeckung (unter Verwendung der reversen Immunologie) durch, um neuartige Antikörper/Ziel-Paare zu entdecken und IND-fähige Studien zu beschleunigen. Absci fördert interne und partnerbasierte therapeutische Programme – wie ABS-201, ein entworfener Antikörper, der Prolaktinrezeptoren für androgenetische Alopezie ins Visier nimmt – und betont schnelle iterative Zyklen zwischen KI und Laborarbeit, um die Entdeckung von Biologika zu beschleunigen.

Beschreibung

• 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

🎯 Anforderungen

• 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

🏖️ Vorteile

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

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