Sr. Vice-President Clinical Development

at  iTeos Therapeutics

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 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.

PROFESSIONAL EXPERIENCE/QUALIFICATIONS

• A highly driven, dynamic, engaged and accomplished physician-scientist with experience and insight will thrive in this role.
• MD or MD/PhD with Oncology drug development experience; experience in immuno-oncology is an advantage.
• 10+ years industry or relevant clinical research experience.
• 5+ years of experience leading a clinical development team with line management experience preferred.
• Demonstrated clinical research acumen with experience in early stage and late-stage development including first-in human trials, proof of concept trials and registration-directed trials; experience with implementation and analysis of pharmacodynamic and potential predictive biomarkers in clinical trials is an advantage.
• Ability to thrive in entrepreneurial biotech environment; prior experience in a small/medium size company is an advantage.
• Excellent interpersonal skills, the ability to function in a highly matrixed team environment, and the ability to negotiate in cross-company collaboration are essential.
• Excellent presentation and writing skills. Fluent in oral and written English.
• Experience with regulatory interactions, interactions around the design and submission of registration-directed trials preferred.
• Exposure to and management of significant accelerations and challenges in clinical programs.
• Ability to work with the Executive Committee and other external audiences such KOLs, regulatory bodies.
• Experience with strategic alliances and/or collaborations.
• Based in Watertown, MA (USA) or Gosselies, Belgium (EU). Ability to travel up to 20% of time. A remote working arrangement for a candidate based in Europe or US East Coast who is willing to be on site up to 50% of time will be considered.

ROLE: SR. VICE-PRESIDENT CLINICAL DEVELOPMENT

This newly created position reporting to iTeos Therapeutic’s Chief Medical Officer will lead clinical development for our rapidly expanding clinical portfolio of promising immuno-oncology therapeutics. The Head of Clinical Development will provide strategic direction and technical leadership to the clinical development team including clinical development strategy and planning, clinical trial design and execution, clinical data analysis, and clinical competitive intelligence. In this position, you will play a key role in the strategy, development, and execution of the clinical pipeline. With a strong medical, regulatory and scientific foundation, the incumbent will work closely with drug development teams to define the most effective approach from first-in-human to registrational clinical studies. The Vice President, Clinical Development will be involved with all facets of the clinical programs, including Phase 1-3 trials progressing to NDAs and will be accountable for clinical sections in regulatory documents (e,g. IND submission, IND annual updates, briefing documents, study protocols, investigator brochures and other study-relevant documents like patient informed consent documents). This role will work across a matrixed organization with CMC, Clinical Operations, Regulatory, Translational Medicine and Biometrics teams to ensure fully harmonized and integrated development strategies and will also work closely with key external collaborators. They will be a key spokesperson at external meetings, including regulatory interactions and scientific meetings.

MAIN RESPONSIBILITIES

• As the strategic leader for Clinical Development provide a strong, clear clinical voice for the clinical programs in collaboration with Clinical Operations, Translational Medicine and Regulatory.
• Inspire, lead and manage the clinical development team based in the US and EU, with direct reporting of the Clinical Development Leads for 3 clinical programs.
• Participate in or lead the Joint Development Committee with GSK on the co-development of EOS-448.
• Lead clinical efforts to establish safety, PK/PD and dose justification for early programs, to establish proof of concepts, and ultimately to secure regulatory approvals. Work with teams to identify best options, evaluate indications and designs and propose scenarios and recommendations to seek Executive Committee and Board of Director approval.
• Medical review and oversight of clinical trial data, external clinical data collection and clinical competitive intelligence.
• Provide strategic perspective and guidance to the preclinical team on new targets and programs.
• Collaborate closely with Regulatory, Clinical Operations, CMC, Translational Medicine and Biometrics to ensure tight strategic integration of product development plans and strategies.
• Be accountable to relevant timelines and deliverables associated with Integrated Product Development Plans.
• Be accountable for all major written deliverables (regulatory submissions, original articles, abstracts), and presentation materials.
• Oversee the cross-functional Protocol Review Committee and be responsible for final review and approval with respect to all controlled documents including protocols, IBs, informed consent forms.
• Maintain the highest quality clinical programs, following GCP and ICH guidelines
• Influence internal and external audiences in a high impact, highly visible fashion.