Offre d'emploi : Clinical Quality Manager (H/F)
iTeos Therapeutics is a publicly-held (NASDAQ: ITOS), clinical-stage biopharmaceutical company dedicated to extending and improving the lives of cancer patients by designing and developing next generation immunotherapies.
Based in Gosselies, Belgium and Cambridge, MA, iTeos Therapeutics was founded out of the Ludwig Institute for Cancer Research (LICR) and the de Duve Institute (UCLouvain) in 2011.
In March 2020, the Company completed a $125 million Series B2 financing, and in July 2020, we completed our IPO raising over $230million of gross proceeds. In June 2021, iTeos entered into a transformative $2.145 billion co-development and co-commercialization agreement with GSK for EOS-448, iTeos’s anti-TIGITmonoclonal antibody. As a well-capitalized biotech company iTeos is positioned to continue to develop our clinical pipeline and maintain our investments in our discovery research team to leverage our fantastic science to improve the lives of cancer patients.
For more information, please visit www.iteostherapeutics.com.
iTeos Therapeutics is now a world-class biotech in cancer immunotherapy. To carry on its growth, expand its pipeline and reinforce its team, iTeos Therapeutics is looking for a (m/f) : Clinical Quality Manager.
The Clinical Quality Manager (CQM) will be responsible for prospective and proactive quality control and oversight of the quality activities related to clinical trials sponsored by iTeos and its associated vendors of clinical trials. The primary responsibilities will be to ensure that clinical processes are conducted in accordance with iTeos Quality Management System and Plan and applicable GCP requirements.
The Clinical Quality Manager will report to VP, Head of Clinical Operations and will support global clinical studies for all product candidates, with one or more indications, from early clinical development to regulatory approval (Phase 1-3) and beyond.
Main responsibilities :
- Establish and maintain strong relationships with internal and external stakeholders to ensure that quality standards are proactively adhered to and collaborate with global GCP QA (Quality Assurance) members to ensure compliance according to the established quality system.
- Serve as the GCP subject matter expert on various clinical development projects by providing high standard of quality guidance, advice, and support on GCP matters.
- Identify potential system gaps within clinical trial conduct and coordinates with the appropriate stakeholders to ensure timely remediation.
- Escalate issues of critical non-compliance and/or lack of urgency in remediation to quality assurance and clinical development management.
- Attend cross-functional team meetings as needed and provides guidance to clinical operations staff to ensure best practices that include iTeos oversight and control of clinical trial conduct and risk-based management.
- Establish mechanisms for the department to design, measure, assess, and improve the quality of the clinical trials deliverables.
- Work effectively with clinical staff and external partners to investigate deviations reported from clinical studies and/or investigational sites and works with teams to ensure trend and impact analysis are performed.
- Support GCP QA and/or clinical development in the development and implementation of quality improvement programs.
- Conduct ongoing reviews of clinical trial documentation proactively ensuring quality, accuracy, and completeness.
- Contribute to iTeos SOP (Standard Operating Procedures) development and review process.
- All other responsibilities as assigned.
Professional experience/qualifications :
- BS degree required, MS or advance degree a plus--preferably in a scientific area.
- Minimum of at least 5-8 years of clinical operations and quality assurance experience and a minimum of 3 years clinical trial oversight experience including working with third party partners or an equivalent combination of education and experience.
- Excellent communication and negotiation skills.
- Maintain high ethical standards and enjoy working with people and information, making decisions, problem solving, making a difference and working in a leadership role.
- Must be a self-starter and used to working independently, however collaborating and ability to influence peers is key.
- Adhere to ethical and good clinical practices and the ability to work as part of a team. As well as work independently in a remote workforce environment.
- Excellent organizational skills and ability to work on multiple projects with competitive timelines is required.
- Strong attention to detail and respect for the need of accuracy of information.
- Exceptional verbal, written, and interpersonal communication and presentation skills.
- Must have a thorough understanding of applicable US (United States) and international GCP regulations/guidelines to facilitate the interpretation and impact of findings of internal and external audits.
- Intermediate to advanced software skills desired (e.g., Microsoft Excel, PowerPoint, Microsoft Project).
- Demonstrate ability to work effectively in cross functional team environment.
- A stimulating position within a high-potential innovative biotech company.
- The opportunity to work in a science-driven, dynamic, human‐sized, respectful and professional environment.
- A challenging scientific and business growth in which you get to bring your knowledge and skills.
- An attractive salary package in line with the position responsibilities and your experience.
Please send your CV together with an adapted cover and your deal sheet to https://www.pahrtners.be/fr/offres-demploi/clinical-quality-manager-mf/or to email@example.com
Your application and related information will remain strictly confidential.