Senior Clinical Trial Manager

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.

Overview of Role:

The Senior Clinical Trial Manager (Sr. CTM) is a highly experienced clinical operations professional responsible for providing strategic leadership and operational oversight of complex global clinical trials coordinates, while leading and driving deliverables at assigned sites, countries or regions. The Sr. CTM is accountable for all aspects of study execution from protocol development support through study closeout and inspection readiness. The Sr. CTM may manage multiple studies or programs simultaneously and provides mentorship and guidance to Clinical Trial Managers and other Clinical Operations personnel.

Role and Responsibilities:

• Oversee site selection, feasibility, activation, enrollment, monitoring, issue escalation, and closeout activities.
• Oversees and provides strategic leadership to site selection, feasibility, enrollment, monitoring issue escalation and close out activities. and operational oversight for global clinical trials from study start-up through closeout.
• Serves as the primary operational lead and escalation point for CROs, ensuring high-quality study execution, data monitoring strategies and enrollment strategies by developing and implementing strong patient enrollment, retention, and data quality strategies.
• Drafts, reviews and approves study-related plans, processes, and documents including Informed Consent Forms, Investigator Agreements (CTA), CRFs, CRF Guidelines, statistical/pharmacokinetic analysis plans, monitoring plans, data management plans, and safety monitoring activities.
• Reviews and approves essential document packages and critical study deliverables.
• Leads Risk Based Quality Management activities and ensures timely resolution of signals and actions. Ensuring study performance metrics and proactively identifies risks, trends, and mitigation strategies.
• Leads sponsor oversight of CRO monitoring activities by reviewing monitoring trip reports; evaluates monitoring quality, identifies cross site trends and risks, and drives timely resolution of critical findings and action items.
• Performs quality oversight visits with a focus on inspection readiness.
• Leads and reviews clinical data listings, reports and dashboards ensuring data currency and completeness inclusive of laboratory, imaging and other protocol required assessments. Identifies data trends and risks, drives cross functional resolution of critical issues to maintain inspection readiness.
• Oversees maintenance, quality, and completeness of the Trial Master File (TMF) and leads TMF quality reviews.
• Oversee the creation and execution of clinical trial activities in accordance with Good Clinical Practices. Ensure compliance of clinical trials with national and international regulatory requirements.
• Leads preparation for audits and regulatory inspections and supports inspection management activities.
• Manages, mentors and provides guidance to CTMs, CRAs, and other Clinical Operations team members.
• Drives continuous improvement initiatives and contributes to development of Clinical Operations processes and standards.
• Represents Clinical Operations on cross-functional study teams and governance meetings.
• All other duties as assigned

Experience, Education and Specialized Knowledge and Skills:

• Bachelor’s degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical-related areas preferred.
• 8–10+ years of clinical operations experience in sponsor pharmaceutical or biotechnology organizations.
• 7+ years of direct clinical trial management experience overseeing phase II/III international oncology clinical trials
• Ability to travel internationally to visit clinical sites and study meetings. Amount will vary upon project needs (up to 20%)
• Proven capabilities to interpret complex scientific concepts with proficiency in reviewing analyzing and critically assessing clinical data to support trial execution and decision making.
• Proven proficiency in overseeing large complex studies being managed in house and by a CRO
• Demonstrated ability to problem-solve in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs.
• Demonstrated ability to lead teams and work in a fast-paced team environment
• Demonstrated ability to solve problems and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs
  Excellent planning, leadership, communication, negotiation, and organizational skills.
• Expert knowledge of the drug development process, ICH guidelines/GCP with a deep understanding of all phases of clinical trial execution and the ability to apply this knowledge to complex, global studies.

This is the pay for this position

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 recruiting@smmttx.com 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.