At a Glance
- Tasks: Lead and manage global clinical trials, ensuring quality and timely delivery.
- Company: Summit Therapeutics is pioneering innovative therapies for cancer treatment.
- Benefits: Enjoy a dynamic work environment with opportunities for professional growth and development.
- Why this job: Join a mission-driven team making a real impact in cancer research and patient care.
- Qualifications: 5+ years in clinical project management; degree in life sciences preferred.
- Other info: Opportunity to work with cutting-edge therapies and collaborate with top professionals in the field.
The predicted salary is between 48000 - 72000 ÂŁ per year.
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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.
Overview of Role:
The Clinical Trial Manager is a highly autonomous and experienced clinical operations professional responsible for all aspects of Clinical Trial Management for global studies. Responsible for study start up and maintenance through study close out. Coordinates, leads and drives leads Summit cross functional team members, CROs and vendors to successfully deliver clinical studies. Responsible for all performance metrics and quality of deliverables in the clinical trial.
Role and Responsibilities:
Oversees study scope, quality, timelines, and budget with the internal Summit functional leads, CRO and vendors to ensure that overall project objectives are met
Initiates and builds solid professional relationships with key opinion leaders and clinical site staff
Partners with the CRO to ensure robust patient enrollment strategies are developed and carried out effectively to ensure patient enrollment is completed on time
Partners with the CRO to ensure robust ongoing data monitoring strategies are developed and carried out effectively to ensure delivery of high-quality data
Proactive identification and management of study related risks
Responsible for the development and management of clinical trial documents including (but not limited to) protocols, Case Report Forms (CRFs), consent documents, confidentiality agreements
Responsible for reviewing and managing study related plans, processes including
Investigator agreements (CTA), CRFs, CRF guidelines, statistical / pharmacokinetic analysis plans, monitoring plan, data management, safety monitoring
Responsible for reviewing CRO and vendor contracts/work orders and specifications to enable study objectives to be met
Reviews and approves essential document packages to enable timely site activations
Reviews pre-study, study initiation, interim monitoring visit and at study closeout visit report
Provides close oversight on the findings on the monitoring reports and loops back with broader team to provide updates
Directs investigator performance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary
Responsible for oversight on the maintenance of the TMF and completeness at the end of the study
Perform periodic QC of the TMF
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 and co-monitoring the assigned clinical trial following company SOPs
Ensures the study is “inspection ready” always
Responsible for oversight and coaching of the functional activities of Clinical Trial Associates allocated to the project
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 area preferred
5+ years of clinical project management experience in conducting international clinical trials in sponsor Pharma/Biotech organization
Prior phase II and III experience required
A solid understanding of the drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process
Experience with budget forecasting and management
Experience with clinical studies in oncology
Ability to travel internationally to visit clinical sites and for study meetings. Amount will vary upon project needs (up to 20%)
Proven proficiency in overseeing large complex studies being managed in house and by a CRO
Demonstrated ability to lead teams and work in a fast-paced team environment
Experienced and enjoys building relationships with KOLs and site personnel
Ability to successfully engage and work collaboratively with overseas clinical operations team members/colleagues
Demonstrated ability to build and deliver on patient enrollment strategies
Excellent interpersonal and decision-making skills. Demonstrates innovation, possesses drive, energy, and enthusiasm to deliver the program objectives
Demonstrated ability to comprehend complex scientific concepts and data
Proficient in reviewing and assessing clinical data
Possesses excellent planning, time management & coordination skills
Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs
Experience in working in a small organization
Excellent written and oral communication skills
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 atrecruiting@smmttx.com to obtain prior written authorization before referring any candidates to Summit.
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Clinical Trial Manager employer: Summit Therapeutics Sub, Inc.
Contact Detail:
Summit Therapeutics Sub, Inc. Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Clinical Trial Manager
✨Tip Number 1
Familiarise yourself with the specific clinical trials mentioned in the job description, especially the HARMONi trials. Understanding the nuances of these studies will help you engage in meaningful conversations during interviews and demonstrate your genuine interest in the role.
✨Tip Number 2
Network with professionals in the clinical trial management field, particularly those who have experience with oncology studies. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in clinical research.
✨Tip Number 3
Showcase your leadership skills by discussing past experiences where you successfully managed cross-functional teams or collaborated with CROs. Highlighting your ability to lead and coordinate effectively will set you apart from other candidates.
✨Tip Number 4
Prepare to discuss your experience with budget forecasting and management, as this is crucial for the Clinical Trial Manager role. Be ready to provide examples of how you've successfully managed budgets in previous projects, which will demonstrate your financial acumen.
We think you need these skills to ace Clinical Trial Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in clinical trial management, particularly in oncology and international studies. Use specific examples that demonstrate your ability to oversee complex projects and manage cross-functional teams.
Craft a Compelling Cover Letter: In your cover letter, express your enthusiasm for the role and the company. Mention your understanding of Summit Therapeutics' work, especially regarding ivonescimab, and how your skills align with their needs. Be sure to include any relevant achievements that showcase your expertise.
Highlight Key Skills: Emphasise your proficiency in Good Clinical Practices (GCP), budget management, and risk identification. These are crucial for the Clinical Trial Manager role, so provide concrete examples of how you've successfully applied these skills in past positions.
Proofread Your Application: Before submitting, thoroughly proofread your application materials. Check for spelling and grammatical errors, and ensure that all information is clear and concise. A polished application reflects your attention to detail, which is vital in clinical trial management.
How to prepare for a job interview at Summit Therapeutics Sub, Inc.
✨Know Your Clinical Trials
Familiarise yourself with the specific clinical trials mentioned in the job description, especially those involving ivonescimab. Understanding the objectives and methodologies of these trials will demonstrate your genuine interest and expertise in the role.
✨Showcase Your Project Management Skills
Be prepared to discuss your experience in managing clinical trials, particularly in a global context. Highlight specific examples where you successfully oversaw timelines, budgets, and quality metrics, as this is crucial for the Clinical Trial Manager position.
✨Build Relationships
Emphasise your ability to establish strong professional relationships with key opinion leaders and clinical site staff. Share examples of how you've effectively collaborated with cross-functional teams and external partners to achieve project goals.
✨Demonstrate Problem-Solving Abilities
Prepare to discuss challenges you've faced in previous clinical trials and how you addressed them. Show that you can proactively identify risks and implement solutions, which is essential for ensuring the success of clinical studies.