Xilio Therapeutics is a development-stage biotechnology company advancing next-generation cancer immunotherapies designed to improve patient outcomes by unleashing the power of the immune system selectively at the site of the tumor. The company’s tumor-selective immunotherapies are based on its proprietary technology, which maximizes the potency of modulating key pathways in immune-oncology and restricts their activity to the tumor to minimize peripheral side effects. The broad applicability of these therapies across cancer types means that all patients could benefit from these potentially curative medicines.
Xilio was founded in 2016 and closed a $95M Series C financing from blue chip venture investors in February 2021. Xilio is headquartered in Waltham, MA.
The Clinical Study Lead (CSL) provides leadership to the Clinical Operations Study Team and cross-functional Clinical Sub-Teams to define study specifications, achieve study milestones through operational feasibility, budget and timeline estimates. The CSL is responsible for overall execution of clinical studies and management of study deliverables. The CSL will drive the scope of work, oversee CROs and will proactively assess and mitigate protocol, GCP and/or applicable regulation compliance and adequacy of trial site and data monitoring to ensure inspection readiness. Acts as the primary point of contact interfacing between, CROs, cross- functional groups, clinical trial sites and vendors. The CSL may be accountable for setting and managing operations across multiple studies. This role reports to the Associate Director, Clinical Operations.
- Perform day to day management and oversight of assigned clinical trial(s) to ensure deliverables are met in all phases of trial
- Lead the Clinical Trial Sub-Team, and support other development teams as a Clinical Operations representative as required
- Directs the operational execution of clinical study activities in accordance with SOPs, ICH Guidelines, and Good Clinical Practices (GCP) to ensure overall data quality, integrity; and patient protection.
- Assist in the planning, tracking and forecasting the Global Clinical Operations budget and timelines for the studies against the agreed goals.
- Contribute to the development and maintenance of study(s) budgets that include short and long-range clinical forecasting and monthly accruals based on clinical activity to support Clinical Development financial goals.
- Key contributor to the development, review and approval of study documents including but not limited to protocol, ICF, study plans, study manuals and reports.
- Review clinical data to ensure timely entry and readiness for data review meetings
- Perform periodic review of clinical data, quality metrics and study deviations
- Review clinical monitoring reports to ensure timely completion and identification of issues
- Perform and document study level Sponsor Oversight of outsourced clinical activities to ensure the appropriate scope of work, oversight and training of clinical investigators and achievement of study milestones within agreed upon timelines and budget.
- Communicates clinical studies performance data to other members of the management and scientific team through internal clinical trial metrics, dashboards and other internal updates
- Ensure clinical trial samples are ready to be sent to vendors in order to meet trial deliverables
- Participate in testing of clinical trial systems/databases (i.e. UAT)
- Participate in clinical operations workstreams related to departmental and operating model related initiatives.
- Develop and maintain strong, collaborative relationships with key stakeholders within and external to Xilio
- A minimum of 7 years' experience in a clinical research and industry environment, including a minimum of 3 years of independent trial management.
- Bachelor’s degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences, or drug development.
- Ability to lead cross-functional teams and to provide management oversight of CROs.
- Demonstrated effectiveness in resolving study management issues.
- Must have thorough understanding of the International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) Guidelines and other applicable regulatory regulations and guidelines.
- Strong interpersonal, organizational, and multi-tasking skills
- Excellent attention to detail and problem-solving skills
- Ability to work independently and in a highly collaborative team environment.