About Summit:
Summit 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.
Summit’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:
Non-small Cell Lung Cancer (NSCLC)
HARMONi: 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.
HARMONi-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.
HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC.
Colorectal Cancer (CRC)
HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.
Ivonescimab 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.
This is a 1-year, renewable Fixed-Term Contract
Role Overview
The 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.
As 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.
This position serves as the primary Summit operational point of contact for assigned clinical trial sites, with full accountability for the end-to-end operational delivery of studies. The role drives study start-up efficiency accelerates site activation and recruitment and maintains high standards of performance and quality throughout the study lifecycle.
The 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.
Key Responsibilities:
Serve as the main operational contact for assigned clinical trial sites across Europe.
Provide leadership and oversight for all operational aspects of site performance, from feasibility through study closeout.
Recommend sites based on indication, experience, capabilities, and local knowledge.
Support and contribute to feasibility assessments and site selection activities.
Engage investigators early to gather feedback on protocol design, recruitment expectations, and local practices.
Drive efficiency in study start-up and expedite site activation timelines.
Maintain deep knowledge of site capabilities, processes, and requirements.
Expertise in European clinical trial and country-specific regulations and guidelines.
Act as a facilitator between Summit functions and site teams to ensure seamless communication and coordination.
Participate in site visits, investigator meetings, and study-related interactions as required.
Proactively identify and address obstacles impacting site recruitment and performance.
Track key performance metrics to assess site progress, mitigate potential risks, and implement corrective actions.
Develop and deploy effective strategies to improve site engagement and performance.
Deliver concierge-level support to sites, ensuring an optimal partnership experience.
Contribute to continuous improvement initiatives within Clinical Operations.
Perform all other duties as assigned.
Qualifications, Experience, and Skills
Education:
Bachelor’s degree (BA/BS) in a scientific or medical discipline required.
Advanced degree (MSc, PharmD, PhD) preferred.
Experience:
Minimum of 8 years of industry experience in clinical research or related functions.
Prior experience as a Clinical Research Associate (CRA) and/or Regional/Clinical Operations Manager within a CRO or sponsor organization highly desirable.
Extensive late-stage oncology clinical trial experience required.
Proven track record of operational excellence in multi-country clinical trial management.
Strong understanding of drug development processes and regulatory environments in Europe.
Skills and Competencies:
Exceptional organizational and planning abilities with demonstrated success in managing complex projects.
Strong analytical and problem-solving skills, with the ability to anticipate challenges and develop pragmatic solutions.
Understand and clearly articulate the development plan and strategic rationale.
Excellent interpersonal, written, and verbal communication skills in English and German (additional European languages a plus).
Ability to build effective partnerships with internal stakeholders, investigators, and external partners.
Demonstrated leadership and influencing skills, with the ability to drive accountability and results.
Comfortable working independently in a fast-paced, dynamic, and global environment.
Willingness to travel up to 75% of the time within Europe and occasionally internationally.
Key Attributes for Success
Strategic thinker with hands-on execution capability.
Strong commitment to quality, timelines, and collaboration.
Agile and proactive in addressing operational challenges.
Passionate about advancing clinical research and improving patient outcomes.
Actual 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.
Summit 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 [email protected] to obtain prior written authorization before referring any candidates to Summit.
Summit 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.
Skills Required
- Bachelor's degree (BA/BS) in a scientific or medical discipline
- Minimum of 8 years of industry experience in clinical research or related functions
- Prior experience as a Clinical Research Associate (CRA) and/or Regional/Clinical Operations Manager within a CRO or sponsor organization
- Extensive late-stage oncology clinical trial experience
- Strong understanding of drug development processes and regulatory environments in Europe
What We Do
Summit Mission Statement: To build a viable, long-lasting health care organization that assumes full responsibility for designing, developing, trial execution and enrollment, regulatory submission and approval, as well as successful commercialization of patient, physician, caregiver, and societal-friendly medicinal therapy intended to: improve quality of life, increase potential duration of life, and resolve serious medical healthcare needs. To identify and control promising product candidates based on exceptional scientific development and administrational expertise, develop our products in a rapid, cost-efficient manner, and to engage commercialization and/or development partners when appropriate. We accomplish this by building a team of world class professional scientists and business administrators that apply their experience and knowledge to this mission. Team Summit exists to pose, strategize, and execute a path forward in medicinal therapeutic health care that places Summit in a well-deserved, top market share, leadership position. Team Summit assumes full responsibility for stimulating continuous expansion of knowledge, ability, capability, and well-being for all involved stakeholders and highly-valued shareholders. Summit was founded in 2003 and our shares are listed on the Nasdaq Global Market (symbol ‘SMMT’). We are headquartered in Miami, Florida, and we have additional offices in Palo Alto, California, Princeton, New Jersey, Oxford, UK, and Dublin, Ireland.
