ABOUT ITEOS THERAPEUTICS, INC

iTeos Therapeutics is a publicly-traded (NASDAQ: ITOS), clinical-stage biopharmaceutical company dedicated to extending and improving the lives of patients with cancer by designing and developing next generation immunotherapies.

Based in Gosselies, Belgium and Watertown, 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 $230 million of gross proceeds. In June 2021, the Company entered into a transformative $2.145 billion co-development and co-commercialization agreement with GSK for EOS-448, the Company’s anti-TIGIT monoclonal antibody. As a well-capitalized biotech company, we are positioned to continue to develop our clinical pipeline and maintain our investments in our discovery research team to leverage our innovative science to improve the lives of patients with cancer.

For more information, please visit www.iteostherapeutics.com.

iTeos Therapeutics is now a world-class actor in the sector. To carry on its growth and reinforce its team, iTeos Therapeutics is looking for a Safety/PV Operations—Safety Specialist/Manager.

ROLE: Safety/PV Operations—Safety Specialist/Manager

The Safety Specialist/Manager is a key position in the Research and Development Department and will report to the Director PV Operations. We expect the successful applicant to leverage his/her PV knowledge within our R&D team focused on regulatory compliance, inspection readiness and vendor management. Practically speaking, in this role, he/she will work independently and as part of a multidisciplinary project team and lead the PV activities on several programs, helping to guide decision making and timely completion of clinical trial tasks.Overall, this is a unique opportunity for an ambitious and talented PV specialist eager to contribute in a meaningful way to the development of innovative drugs for cancer patients.

The successful candidate will have a strong PV background in premarketing programs and excellent communication skills.

MAIN RESPONSIBILITIES

• Responsible for tracking clinical trial SAEs and SUSARs, monitoring timelines for event processing in alignment with CRO/vendor KPIs.
• Manage and maintain compliance listings for all expedited reports.
• Oversight of CRO/vendor case processing activities (monitor data quality, queries, narratives).
• Support implementation of safety management plans (SMPs) for the clinical trial programs.
• Participate in the development of PV infrastructure documents (SOPs, work instructions, training materials).
• Track all PV CRO/vendor action items and requests.
• Attend clinical trial team meetings as PV representative.

PROFESSIONAL EXPERIENCE/QUALIFICATIONS

Mandatory:

• College degree, preferably in life sciences.
• 5 years’ experience in pharmaceutical industry with clinical trial PV experience.
• Experience with global clinical trial programs; deep knowledge of global regulatory requirements for SUSAR reporting.
• Working knowledge of safety database systems (Argus, Aris G, Veeva, etc) and medical terminology required.

Preferred skills:

• Experience with CRO/vendor management.
• Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, Teams, and SharePoint.
• Ability to work independently and in a team environment.
• Ability to be flexible, ensure consistency and identify priority projects while working on multiple programs.
• Excellent interpersonal skills and written and verbal communication skills, English fluency required.

LEADERSHIP CHARACTERISTICS

• Resourceful, collaborative, detail oriented.
• Approaches challenges with creativity and pragmatism. Ability to work in a fast-moving and challenging biotech environment.
• Ability to engage teams to achieve goals without direct authority.
• Driven to move the R&D programs forward at full speed while maintaining quality.

OFFER

• 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 environment where you are empowered to and develop your knowledge and skills as part of a talented and highly engaged global team.
• An attractive compensation and benefits package in line with the position responsibilities and your experience.

RECRUITMENT PROCESS

Please send your CV together with an adapted cover letter to the following address: jobs@iteostherapeutics.com. Please mention the reference SS in the mail object. Your application and related information will strictly confidential.

For this open vacancy in US, we closely collaborate with Planet Pharma (Recruitment & Selection company). Your application will be automatically forwarded to them. We, together with Planet Pharma, will keep all your data confidential (GDPR compliant approach).