iTeos Therapeutics is a privately-held, clinical-stage biopharmaceutical company dedicated to extending and improving the lives of cancer patients by designing and developing next generation immunotherapies. iTeos Therapeutics is advancing its two main programs into a phase I/II clinical stage. The first program is an insurmountable and non-brain penetrant adenosine A2A receptor antagonist. The second program is a human ADCC-enabling anti-TIGIT antibody.
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 led by 6 main US Venture Capitalists. All previous investors including Fund +, VIVES II and SRIW, as well as SFPI, also participated in this funding round. 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 (m/f) :
Director of Regulatory Affairs
The Director of Regulatory Affairs will be a key member of iTeos Therapeutics’ Leadership Team and be responsible for developing iTeos Therapeutics’ global regulatory strategy, represent iTeos in regulatory interactions and ensure execution of regulatory requirements and provide input into internal quality systems. This role requires expert interpretation of requirements relating to the development and licensing of cancer therapeutics and communication to cross-functional teams to create innovative regulatory strategies for targeted small molecules and biologics to treat cancer. This position will report to the Chief Medical Officer and will have extensive interface with the senior management team.
- Responsible for developing innovative global regulatory strategies and working with the cross-functional project team on execution.
- Leads interactions with global regulatory agencies.
- Represents regulatory affairs in the leadership team and on cross-functional project teams to provide regulatory guidance and education through the interpretation of regulations, policies, procedures, guidelines, and compliance requirements.
- Provides oversight for regulatory staff (whether at CRO or internally) and assesses and makes recommendations on staffing requirements.
- Develops and manages regulatory submissions and related supplements and amendments with the support of a CRO.
- Responsible for developing and maintaining regulatory strategy documents.
- Interacts directly with health authorities and maintains excellent relationship with regulatory personnel.
- Works with the team to integrate biomarker/companion diagnostic strategies into the development of assigned programs.
- Educates company on regulatory requirements and evolving trends and disseminates regulatory policy and intelligence relevant to the business.
- Provides regulatory due diligence assessments of new business opportunities.
- Advanced degree in a scientific or health-related field
- Seasoned professional with at least 10 years of regulatory affairs experience in the biopharmaceutical industry
- Exceptional communication and presentation skills to articulate complex regulatory strategy and decision-making both internally and externally
- Experience and comfort with pushing the boundaries and asking challenging questions both of the internal team and of the regulatory authorities.
- Experience in providing strategic advice on integrated regulatory development plans and executing regulatory strategy for cancer therapeutics.
- In-depth working knowledge of regulations, guidance, policies, and procedures pertinent to drug and biologics development and operational knowledge of IND/CTA and NDA/BLA/MAA submissions.
- Experience with development of biomarkers and IVD companion diagnostics devices preferred.
- Exceptional writing skills with experience in drafting and submitting timely drug and biologic applications to health authorities.
- Track record of building an excellent relationship with the FDA, EMA and other regulatory agencies.
- Quality mindset.
LEADERSHIP CHARACTERISTICS :
- Entrepreneurial, resourceful, energetic, self-starter
- Approaches challenges with creativity and pragmatism
- Ability to engage team to achieve goals without direct authority
- A stimulating scientific 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.
- Varied contacts inside the company, the biotech/pharma sector and the scientific world.
- A long-term contract and an attractive salary package in line with the position responsibilities and your experience.