Senior Manager, Clinical Site Partner (Italy)

ph3Senior Manager, Clinical Site Partner (Italy) /h3 pAzienda : Summit Therapeutics Plcbr/Tipo Lavoro : Full Time Italy /p h3Descrizione Lavoro - Senior Manager, Clinical Site Partner (Italy) /h3 bAbout Summit: /b pSummit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence. /p pSummit’s team is inspired to touch and help change lives through Summit’s clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including: /p h3Non-small Cell Lung Cancer (NSCLC) /h3 ul liHARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI. /li liHARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. /li liHARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC. /li /ul h3Colorectal Cancer (CRC) /h3 ul liHARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy. /li /ul pIvonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland. /p h3Role Overview /h3 pThe Senior Manager, Clinical Operations Site Partner (CSP) is responsible for providing leadership and operational expertise in the execution of one or more Phase I–III clinical trials across the European region. /p pAs a key member of the Global Clinical Operations (GCO) group and reporting to the Senior Director, Clinical Operations (Europe), the Senior Manager CSP plays a pivotal role in ensuring operational excellence in trial conduct and site performance. /p pThis position serves as the primary Summit operational point of contact for assigned clinical trial sites, with full accountability for the end-to-end lifecycle of studies. The role drives site selection, site start-up efficiency, accelerates site activation, recruitment, and maintains high standards of performance and quality throughout the study lifecycle. /p pThe Senior Manager CSP acts as a strategic partner to sites and study teams—helping Summit achieve its vision of becoming a Sponsor of Choice by delivering a concierge-level experience to our clinical trial sites. /p h3Key Responsibilities /h3 ul liServe as the main operational contact for assigned clinical trial sites across Europe. /li liProvide leadership and oversight for all operational aspects of site performance, from feasibility through study closeout. /li liRecommend sites based on indication, experience, capabilities, and local knowledge. /li liEngage with feasibility assessments and site selection activities. /li liInvolve sites early to gather feedback on protocol design, recruitment expectations, and local practices. /li liDrive efficiency in study start-up and expedite site activation timelines. /li liMaintain deep knowledge of site capabilities, processes, and requirements. /li liExpertise in European clinical trial and country-specific regulations and guidelines. /li liAct as a facilitator between Summit functions and site teams to ensure seamless communication and coordination. /li liParticipate in site visits, investigator meetings, and study-related interactions as required. /li liProactively identify and address obstacles impacting site recruitment and performance. /li liTrack key performance metrics to assess site progress, mitigate potential risks, and implement corrective actions. /li liDevelop and deploy effective strategies to improve site engagement and performance. /li liDeliver concierge-level support to sites, ensuring an optimal partnership experience. /li liContribute to continuous improvement initiatives within Clinical Operations. /li liPerform all other duties as assigned. /li /ul h3Qualifications, Experience, and Skills /h3 h3Education: /h3 ul liBachelor’s degree (BA/BS) in a scientific or medical discipline required. /li liAdvanced degree (MSc, PharmD, PhD) preferred. /li /ul h3Experience: /h3 ul liMinimum of 8 years of industry experience in clinical research or related functions. /li liPrior experience as a Senior Clinical Research Associate (SCRA) and/or Regional/Clinical Operations Manager within a CRO or sponsor organization highly desirable. /li liExtensive late-stage oncology clinical trial experience required. /li liProven track record of operational excellence in multi-country clinical trial management. /li liStrong understanding of drug development processes and regulatory environments in Europe. /li /ul h3Skills and Competencies: /h3 ul liExcellent interpersonal, written, and verbal communication skills in Italian and English (additional European languages a plus). /li liExceptional organizational and planning abilities with demonstrated success in managing complex projects. /li liStrong analytical and problem-solving skills, with the ability to anticipate challenges and develop pragmatic solutions. /li liUnderstand and clearly articulate the development plan and strategic rationale. /li liAbility to build effective partnerships with internal stakeholders, investigators, and external partners. /li liDemonstrated leadership and influencing skills, with the ability to drive accountability and results. /li liComfortable working independently in a fast-paced, dynamic, and global environment. /li liWillingness to travel up to 75% of the time within Europe and occasionally internationally. /li /ul h3Key Attributes for Success /h3 ul liStrategic thinker with hands-on execution capability. /li liStrong commitment to quality, timelines, and collaboration. /li liAgile and proactive in addressing operational challenges. /li liPassionate about advancing clinical research and improving patient outcomes. /li /ul pActual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation. /p pSummit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at to obtain prior written authorization before referring any candidates to Summit. /p pSummit Therapeutics Inc.is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. We do not discriminate in recruitment, hiring, training or promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. /p /p #J-18808-Ljbffr