Senior Manager, Clinical Operations Site Partner

Summit Therapeutics Sub, Inc.; Deutschland; Remote; EUR 80.000 - 120.000; Vollzeit

Zusammenfassung

A global biopharmaceutical company is seeking a Senior Manager, Clinical Operations Site Partner to lead clinical trials across Europe. The ideal candidate will have over 8 years of experience in clinical research and demonstrate operational excellence in multi-country trial management. This role requires strong leadership and communication skills, with a focus on enhancing site performance and maintaining high-quality standards.

Qualifikationen

• Minimum of 8 years of industry experience in clinical research or related functions.
• Prior experience as a Clinical Research Associate (CRA) within a CRO or sponsor organization is highly desirable.
• Strong understanding of drug development processes and regulatory environments in Europe.

Aufgaben

• Serve as the main operational contact for assigned clinical trial sites across Europe.
• Provide leadership and oversight for all operational aspects of site performance.
• Track key performance metrics to assess site progress and implement corrective actions.

Kenntnisse

Leadership

Analytical thinking

Communication

Project management

Problem-solving

Ausbildung

Bachelor's degree in a scientific or medical discipline

Advanced degree (MSc, PharmD, PhD)

Jobbeschreibung

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Senior Manager, Clinical Operations Site Partner

Ivonescimab, known as SMT112, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD-1 and VEGF.

Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), with three active Phase III trials:

• HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced, or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib).
• HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.
• HARMONi-7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression.

Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit's license territories, including the United States and Europe. Ivonescimab was approved for marketing authorization in China in May 2024. Ivonescimab was granted Fast Track designation by the US Food & Drug Administration (FDA) for the HARMONi clinical trial setting.

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–II 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痴 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.

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 [e-mail] to obtain prior written authorization before referring any candidates to Summit.