Study Team Lead
Il y a 6 mois
**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.
Our values - Data Driven, Ownership, Courage, and Stronger Together - form the foundation of who we are as a company and define who we are at our core.
**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 Study Team Lead.**
**ROLE: Study Team Lead**
The role is accountable for the execution of the clinical trial(s) assigned to him/her. The STL ensures that trials are delivered according to the agreed timelines and budget and are conducted in compliance with the applicable regulatory requirements, the relevant standard operating procedures, the applicable quality standards, and the study protocol.
The STL provides operational leadership to a cross-functional study team in charge of the execution of the clinical trial. The STL coordinates and streamlines the trial activities ensuring effective cross-functional teamwork among study team members incl. internal and external stakeholders.
The STL serves as the operational point-of-contact between the study team and the clinical sub team.
The STL performs global oversight of the trial and supervises the different activities involved in the execution of the trial.
**MAIN RESPONSIBILITIES**
LEADING THE STUDY TEAM
- Sets up and leads the Study Team to meet clinical trial objectives.
- Manages internal and external stakeholders of the clinical study and coordinates their activities on the trial.
- Oversees trial activities and ensures adequate follow-up by organizing regular study team meetings in-house and with the CROs as required.
- Provides trouble-shooting and problem resolution support for study team to ensure productive, efficient study delivery.
- Provides feedback on performance, capabilities and competencies of study members to line management.
TRIAL EXECUTION & OVERSIGHT
- Ensures operational execution of clinical studies in terms of cost, timeliness and efficiency, while assuring data quality and integrity.
- Ensures that critical study timelines are accurately forecasted and achieved, and that recruitment targets, data and audit quality are met.
- Identifies risks and issues that may impact study delivery. Ensures risk mitigation plans are effectively implemented and follows up impact. Ensures the accuracy of study systems/trackers, including completeness of the TMF.
- Reports study delivery progress to study team and key stakeholders.
- Defines and follows up Key Performance Indicators (KPI) to follow up study progress and performance.
- Oversees the development of clinical study documents such as study protocols, informed consent forms (ICFs) and regulatory files.
- Responsible for the selection of countries and sites in collaboration with the study team and CRO.
- Manages CROs and study-related vendors, develops relationships and tracks their performance using KPIs. Participates to negotiating the contract and change orders and establishing a fair and accurate budget.
**LEADERSHIP BEHAVIORS**
- Collaborates: Building partnerships and working collaboratively with others to meet shared objectives.
- Builds Networks: Effectively building formal and informal relationship networks inside and outside the organization.
- Drives Engagement: Creating a climate where people are motivated to do their best to help the organization achieves its objectives.
- Action Oriented: Taking on new opportunities and tough challenges with a sense of urgency, high energy, and enthusiasm.
- Being Resilient: Rebounding from setbacks and adversity when facing difficult situations.
- Plans & Aligns: Planning and prioritizing work to meet commitments aligned with organizational goals.
- Directs Work: Providing direction, delegating, and removing obstacles to get work done.
- Ensures Accountability: Holding self and others accountable for meeting commitments.
- Courage: Rising up to address difficult issues, saying what needs to be said.
**FUNCTIONAL COMPETENCIE
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