Working at iTeos

Associate Director Regulatory Affairs - Gosselies, (BELGIUM)

AD-RA

ABOUT ITEOS THERAPEUTICS SA

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 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 $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 an Associate Director Regulatory Affairs .

ROLE:  Associate Director Regulatory Affairs

The Head of Regulatory Affairs has been supporting regulatory activities related to ex-US filings since October 2020 (details of activities in the “Key responsibilities”section below). Currently there are four clinical trials ongoing in Europe. 

In 2021, there is a plan to file three CTA amendments (filings in three countries) and two new CTAs in European countries (number to be determined), Asia and Canada. 

The Head of Regulatory has been collaborating with CROs (Synteract, Precision for Medicine) and iTeos Clinical Operations in dedicated regulatory meetings. Study team meetings have recently been initiated for some clinical studies, and more will be added in the near future. Additional time for regulatory participation in the additional study team meetings, and interactions with a new CRO (Worldwide) will be required in 2021. 

In addition to the regular meetings with Clin Ops and the CROs, there are ad-hoc meetings to discuss multiple challenges. If additional regulatory support is available, this new person could attend to the ad-hoc requests and participate in other functions’ sub team meetings fostering a closer collaboration (Clinical Operations; CROs; CMC). 

One of the reason to reinforce the Regulatory Affairs department in EU zone is mainly to have opportunities for sub-teams who are based in Europe to meet with regulatory outside of US business hours. There is a possibility to seek scientific advice in Europe, and a new team member could lead this activity for iTeos. 
The candidate will report to the Vice President of Regulatory Affairs and will work in a cross-functional matrix structure with other R&D functions. This is an exciting opportunity for an ambitious and talented regulatory professional wanting to contribute in a meaningful way to the development of innovative IO drugs for cancer patients. 

MAIN RESPONSIBILITIES

  • Provide regulatory support for all iTeos products including managing regulatory interactions and clinical trial applications in Europe and International countries.
  • Advise on regulatory strategies from EU perspective (act as the EU regulatory expert).
  • Coordinate all aspects of regulatory submissions, e.g.:
    • Develop and manage regulatory project timelines ;
    • Provide regulatory guidance on requirements for CTA filings ;
    • Coordinate preparation of regulatory documentation (CTAs, meeting materials, briefing books, DSURs, orphan drug designations, pediatric investigational plans, etc.) ;
    • Approve relevant submissions and components (e.g. labels).
    • Coordinate response to Agency’s queries.
    • Oversee, manage and coordinate the regulatory collaboration with the CROs and partner organizations.
    • Participate as a regulatory representative at relevant teams (e.g. Clinical Operations, Project Teams) advising on submission preparation timelines, processes and requirements.
  • Monitor and evaluate the European regulatory affairs environment. Maintain an awareness of current and future risks that may impact business.

PROFESSIONAL EXPERIENCE/QUALIFICATIONS

  • B.S. or Msc, degree within a scientific discipline required with 7+ years’ experience in EU Regulatory Affairs (Pharmaceutical or Biotechnology Industry). 
  • All-rounder profile with specific experience in managing submissions encompassing all areas of regulatory affairs (CMC, Clinical, Non Clinical,…).
  • Canada and Asia Regulatory experience is a plus
  • Highly detail oriented with ability to interpret complex information via excellent written, presentation/oral communication, and customer service skills.
  • Proficient knowledge of MS Office (Excel, PowerPoint,  Project, etc).
  • Effective collaborator who can bring together multiple stakeholders and able to build positive relationships, with both internal and external partners.
  • Change-Agility needed, a mindset who can thrive in a dynamic, complex, and regulated environment.
  • Based in Belgium (or EU if coming to the office in Belgium on regular basis). 

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 in which you get to bring your knowledge and skills
  • A permanent contract and an attractive salary 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 AD-RA in the mail object. Your application and related information will remain strictly confidential.

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

Interested ?

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