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Head of Clinical Operations - CAMBRIDGE, MA (USA) or GOSSELIES, (BELGIUM)

February 2nd 2021

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 $200 million of proceeds. This additional capital will allow us to continue to develop our clinical pipeline and maintain our investments in our discovery research team to leverage its fantastic science to improve the lives of cancer patients.

Mission Description

ROLE:  HEAD OF CLINICAL OPERATIONS
iTeos Therapeutics is seeking a collaborative, dynamic and enthusiastic individual to be responsible for the oversight and execution of clinical trials to ensure that they are completed in a cost-efficient, timely and efficient manner, while assuring data quality and integrity.

ESSENTIAL DUTIES & RESPONSIBILITIES 
Lead the development of the operational plans for all clinical deliverables across two growing clinical programs and plan for additional entries into clinic. Main responsibilities include coordination and leadership of the clinical operations functions, study and resource planning, financial oversight, vendor selection and management, ensuring GCP compliance and adherence to SOP and best practices and providing expertise and strategic guidance. The job holder will serve as a functional leader, line manager, a key member of the Clinical Development Leadership Team, and a subject matter expert, and will work collaboratively with the Project Heads, and other senior or functional leaders to achieve departmental and corporate objectives and initiatives. With extensive industry knowledge and experience, the job holder will evaluate the clinical operations systems, make recommendations on optimal internal staffing and out-sourcing, and will pro-actively seek to improve the efficiency and quality of clinical trial 
execution. Specifically, the Head of Clinical Operations will:

  • Inspire and lead the global clinical operations team, including Trial Operations and other clinical functions to set and achieve ambitious goals to progress our clinical programs and achieve our objectives, while maintaining quality standards including adherence to GCP and all applicable guidelines and regulations
  • Serve on the Clinical Development Leadership Team, working closely with other members of the team to oversee, plan for and execute iTeos’ Clinical Development projects
  • Ensure sufficient resources for Clinical Trial Management with the Head of Trial Operations and evaluate the need for other outsourced or internal clinical functions (for example, data management, trial monitoring, pharmacovigilance and biometrics) and efficiently identifying external resources or qualified hires to fill resourcing gaps.
  • Evaluate scenarios and make recommendation on the optimal mix of internal and external resources to ensure efficient use of budget, ability to adapt to changing demands, and appropriate oversight of quality.
  • Participate in Clinical Strategy meetings, developing iTeos Therapeutics clinical programs and high-level study plans, providing input into operational aspects of the programs and identifying cost drivers and opportunities for efficiency. 
  • Provide rapid analysis of options and trade-offs between timelines, budgets, and execution goals and presentation of scenarios for joint decision-making on the optimal strategy.
  • Ensure alignment across projects and maintain clinical quality to ensure compliance with Good Clinical Practice and applicable regulations.
  • Ensure efficient clinical operational plans and manage successful and timely execution of sponsored clinical trials.
  • Oversee the selection and management of CROs and study-related or cross-study vendors in collaboration with functional leaders and project leaders.
  • Review and approve all study-related contracts and budgets and contribute to long-term forecasting for operational activities and clinical budgets. 
  • Implement continuous improvement initiatives to identify, track and optimize key markers of performance within clinical operations.

Candidate profile

  • A Bachelor’s Degree is required. A Master’s Degree or other advance degree in life science or related field is preferred. 
  • Mastery of complex clinical trial designs and operational issues in all phases of clinical development with a minimum of 10 years of increasing responsibility in clinical trial management, with experience in oncology. Experience managing global clinical operations for late-stage studies is required.
  • Thorough understanding of relevant ICH and GCP guidelines and other applicable international regulations
  • Demonstrated commercial acumen and ability to influence senior leaders and stakeholders in terms of trial design and execution strategy
  • Extensive CRO selection, negotiation, and oversight experience and solid vendor management skills
  • Ability to provide motivational leadership to the organization and to take on and achieve challenging operational goals
  • Team-oriented with excellent cross-functional collaboration 
  • Excellent interpersonal, verbal and written communication skills 
  • Fluent in English (oral and written communication). 
  • Ability and willingness to travel 20% of the time (internationally and domestically). A well-qualified remote worker will be considered if there is ability and willingness to be present on site ~50% of the time.
  • The above description is intended to describe the general nature of the job that may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.

 

Offer

  • A stimulating position within a high-potential innovative biotech company
  • The opportunity to work in a science-driven, dynamic, respectful and professional environment
  • A challenging scientific and business growth in which you get to bring your knowledge and skills
  • An employment agreement with an attractive salary package in line with the position responsibilities and your experience
     

Contact Details

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

For this position, we closely collaborate with a Recruitment & Selection company, Coulter Partners. Your application will be automatically forwarded to them. We, together with Coulter Partners , will keep all your data confidential (GDPR compliant approach).