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 Associate Director, Clinical Operations is a highly autonomous and experienced clinical operations professional responsible for all aspects of Clinical Trial Management for global studies. This position is responsible for study start up and maintenance through study close out. The Associate Director, CTM will coordinate, lead and drive Summit’s cross functional team members, CROs, and vendors to successfully deliver clinical studies. They will be 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
- Fosters solid professional relationships with key opinion leaders and clinical site staff
- Partners with CRO(s) to ensure robust patient enrollment strategies are developed and carried out effectively and on time
- Partners with CRO(s) 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, and safety monitoring
- Reviews CRO(s) 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 (GCP)
- 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 Research Associates and 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
- 10+ years of clinical project management experience in conducting international clinical trials in sponsor Pharma/Biotech organization
- A minimum of 2+ years of phase II and III combined experience required
- Strong 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 strongly preferred.
- 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
- Line management (direct reports) experience is preferred.
- Demonstrated abilities to effectively delegate and manage others, as evidenced through either past people management or matrix management responsibilities.
- Proven track record of 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 and communicate 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
- Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools desirable
- Strong attention to detail, accuracy and confidentiality
- Must be able to effectively multi-task and manage time-sensitive and highly confidential documents
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.
Top Skills
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.
