Director, Clinical Operations Study Start-Up

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. Summits 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.

Summits team is inspired to touch and help change lives through Summits 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 Chinas National Medical Products Administration (NMPA). Summit is headquartered in Miami Florida and has additional offices in California New Jersey the UK and Ireland.

Overview:

The Director of Clinical Operations Study Start-Up will oversee the Study Start-Up portfolio managing Study Start-Up activities. This role takes direction from the Clinical Operations Leadership will set the strategic direction for Study Start-Up planning and will provide oversight and leadership to drive the Study Start-Up activities. Furthermore the Director Site Contract and SSU will work collaboratively with all business partners to communicate decisions issues risks and mitigations and will function as an SME to drive accelerated Start-Up timelines.

Roles and Responsibilities:

• Provide strategic and operational leadership for endtoend study startup activities across assigned clinical programs ensuring timely compliant and highquality site activation.
• Leads multiple programs to ensure investigative sites are activated in accordance with the timelines set for each study.
• Accountable for development execution and ongoing optimization of studyspecific startup strategies including country selection regulatory and ethics submissions site feasibility and selection contract and budget execution and site activation readiness.
• Establish and maintain clear startup timelines metrics and dashboards; proactively identify risks to activation timelines and drive mitigation plans to achieve first site activation (FSI).
• Provide oversight of country and sitelevel regulatory and ethics submissions (e.g. IRB/EC/HA) ensuring consistency with global strategy and local regulatory requirements.
• Monitor vendor performance and participate in Vendor Governance as needed.
• Performs proactive risk assessment to anticipate study specific challenges and requirements and communicates in advance to the internal team to plan and mitigate risk.
• Analyzes projects through the collection tracking and trending metrics and KPI assessments and guides internal and external teams to achieve industry leading results for study activation.
• Ensure quality completeness and inspection readiness of startup documentation in accordance with GCP and internal SOPs.
• Partner with Clinical Research Organization(s) to oversee site contract and budget negotiations ensuring alignment with approved study budgets and timely execution to support activation timelines.
• Serve as the primary escalation point for complex startup challenges including site readiness or performance risks regulatory delays or vendor issues; communicate status and resolution plans to senior leadership.
• Contribute to portfoliolevel planning by providing startup insights and recommendations to inform study design country strategy resourcing and feasibility assumptions.
• Develop and maintain study startup processes systems and tools to reduce cycle times improve quality and enhance predictability of startup delivery.
• Ensure startup activities are conducted in compliance with global regulations internal policies and company quality standards maintaining a strong focus on patient safety and data integrity.
• Support organizational readiness for audits and inspections related to study startup activities partnering with Quality Assurance as needed.
• People management and development responsibilities and may have financial accountabilities for assigned staff.
• Contribute to process improvement development of SOPs and study start up documents.

Experience Education and Specialized Knowledge and Skills

• Minimum BA/BS degree or relevant graduate degree highly preferred
• Requires minimum of 15 years of experience in the biotech/pharmaceutical industry with direct experience in feasibility study start-up site activation for global Phase 3 clinical trials development of Master and country level ICFs site payments eTMF CTMS vendor oversight and inspection readiness with a strong understanding of global regulatory requirements and clinical operations and with over 5 years of supervisory/management experience.
• Proven track record in process improvement clinical trial execution and operational strategy.
• Experience with planning management and oversight of activities and deliverables within Clinical Operations
• Strong understanding of clinical trial management ICH-GCP and regulatory compliance
• Strong organizational and project management skills with a deep understanding of regulatory and submission processes in various countries with ability to oversee multiple studies and priorities simultaneously.
• In-depth understanding of relevant Clinical Research Feasibility Study Start-Up processes and clinical operations
• Solid working knowledge of ICH FDA IRB/IEC and other applicable regulations/guidelines and extensive experience with investigative site Start-Up documents
• Proven track record of managing multiple projects and/or programs concurrently.
• Excellent analytical problem-solving and organizational skills.
• Strong communication and interpersonal skills with the ability to influence cross-functional stakeholders.
• Demonstrated ability to lead changes and foster a culture of continuous improvement.

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 Summits Talent Acquisition team atto obtain prior written authorization before referring any candidates to Summit.

Summit Therapeutics 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.