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.
SENIOR CLINICAL TRIAL ASSOCIATE
Overview of Role:
The Senior Clinical Trial Associate (Senior CTA) is an experienced clinical operations professional who is responsible for supporting the daily workflow of clinical operations activities. They will provide robust administrative support to study teams throughout the study. Key administrative activities include, but are not limited to, managing meeting invitations, creating agendas and meeting minutes, study document filing, maintaining study trackers, and oversight of the eTMF and vendors.
Role and Responsibilities:
- Provides comprehensive administrative support to the clinical operations study team,including managing meeting logistics, creating agendas, and drafting meeting minutes, withminimal oversite
- Executes tasks as assigned by the Clinical Operations Manager, including study budgetforecasting and tracking
- Ensures accurate and timely documentation, including eTMF management, study contractsand financial records in compliance with ICH-GCP, company policies and regulatoryrequirements
- Coordinates clinical operations activities across cross-functional teams, including contractmanagement, vendor oversight, site start-up and activation, protocol deviation
- Creates and maintains study-related materials, such as country and site binders and trackstrial milestones
- Ensure the eTMF is being maintained up-to-date and all essential documents areappropriately filed in the eTMF
- Collaborates with CROs to ensure accurate data collection and entry into the CTMS andEDC
- Attend and contribute to team meetings, taking detailed meeting minutes
- Supports clinical study management as delegated by Clinical Operations managers, including liaison with external vendors
- Actively participates in process improvement initiatives to enhance clinical operations efficiency
- All other duties as assigned
Experience, Education and Specialized Knowledge and Skills:
- Bachelor’s degree in biological sciences, health sciences or medical field, or equivalent combination of education and experience required 4+ years of experience in clinical study environment within CRO or Pharmaceutical company
- Experience using Clinical Trial Management Systems (CTMS) and Clinical Trial Master File Systems (eTMF) required • Strong understanding of the phases of clinical drug development and clinical operation processes from start-up to close-out
- Knowledge of applicable FDA Code of Federal Regulations, Good Clinical Practices, and ICH guidelines
- Ability to organize, prioritize tasks, identify and resolve issues efficiently. Manage multiple tasks effectively and follow through on assigned tasks.
- Ability to receive general instructions on new assignments and perform routine work independently. Collaborate and work effectively within a team and within a multi-disciplinary environment.
- Outstanding interpersonal skills coupled with the ability to communicate effectively in both oral and written form
- Attention to detail, accuracy and confidentiality
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 [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 in biological sciences, health sciences, medical field, or equivalent combination of education and experience
- 4+ years of experience in a clinical study environment within a CRO or pharmaceutical company
- Experience using Clinical Trial Management Systems (CTMS)
- Experience using Clinical Trial Master File systems (eTMF)
- Experience with Electronic Data Capture (EDC) and interaction with CTMS/EDC
- Strong understanding of phases of clinical drug development and clinical operations from start-up to close-out
- Knowledge of FDA Code of Federal Regulations, Good Clinical Practices (GCP), and ICH guidelines
- Ability to organize, prioritize, manage multiple tasks, and resolve issues efficiently
- Outstanding interpersonal and written/oral communication skills, attention to detail, accuracy and confidentiality
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.
