Senior Director Clinical Operations, Study Start-Up

Location: On-Site 4 days per week at our Menlo Park CA Princeton NJ or Miami FL locations

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 of Role:

We are seeking an experienced Senior Director Study Start-Up to lead global study start-up activities across our oncology clinical development portfolio. This is a highly visible hands-on leadership role responsible for enabling rapid first-patient-in (FPI) timelines while ensuring quality compliance and inspection readiness.

The ideal candidate brings deep expertise in oncology study start-up thrives in a lean biotech environment and can balance strategic leadership with operational execution across Phase IIIII trials. As the department scales this leader will be responsible for evolving the function into a Center of Excellence for Site Activation utilizing predictive analytics and standardized workflows to drive portfolio-wide efficiency.

Role and Responsibilities:

• Lead and oversee global oncology study start-up activities from site selection through site activation
• Drive timely site activations across regions regulatory readiness contracts budgets and essential core documents
• Collaborate with legal finance CRO and clinical teams to ensure site agreements comply with country regulatory and company standards
• Partner closely with Legal counsel to ensure appropriate indemnification liability and confidentiality provisions are included in contracts; oversee the complex negotiation of clinical trial insurance certificates and country-specific mandates.
• Manage and develop a team of direct reports providing active mentorship performance management and career development; extend mentorship to non-direct reports within the broader Clinical Operations department to harmonize start-up best practices.
• Build optimize and scale study start-up processes SOPs and playbooks suitable for a growing biotech; lead formal process improvement initiatives to reduce cycle times from site selection to activation.
• Drive the standardization of core study documents including global Master Informed Consent Forms (ICF) Investigator Packages and essential document checklists to ensure consistency and speed.
• Partner with Business Operations and IT to identify and implement technology solutions (e.g. SSU tracking modules eTMF automation) to replace manual processes and improve data transparency.
• Partner closely with Clinical Operations Clinical Development Quality Legal and Finance
• Confidently present the budget to the Chief Accounting Officer and Head of Clinical Operations for approval ensuring full knowledgeable of all details
• Partner with Finance team to provide study-wide site payment estimates and forecasts
• Provide regular updates to management on progress and key performance indicators related to trial agreements
• Establish and track start-up KPIs and metrics to improve predictability and cycle times
• Provide oversight and governance of CROs FSP Providers and start-up vendors including performance management and issue escalation

Experience Education and Specialized Knowledge and Skills:

• Bachelors degree in Life Sciences Business Administration or related field required
• At least 12 years of experience in managing global clinical trials
• Proven track record of successfully managing direct reports and leading cross-functional teams through influence in a matrixed environment.
• Demonstrated experience in process improvement and the application of technology to streamline clinical operations.
• Deep knowledge of ICF development clinical trial insurance requirements protocol amendment process and global regulatory document standards.
• Strong negotiation and vendor management experience required
• Experience in oncology trial management
• Data-driven leader with expertise in start-up metrics and forecasting
• Demonstrated successful management and oversight of CROs and other service providers
• Ability to operate strategically while remaining hands-on and execution-focused
• Ensure compliance with regulatory requirements Good Clinical Practice (GCP) guidelines and internal standard operating procedures (SOPs) throughout the study start-up phase
• Comfortable working in fast-paced resource-lean biotech environments
• Experience in GrantPlan
• Excellent communication and cross-functional leadership skills
• Strong attention to detail with the ability to lead and function as rational and humble problem solver
• Leadership experience with the ability to inspire excellence in themselves and those around them
• High-quality executor; ability to execute against goals and milestones with quality precision and speed

The pay range for this role is $225000 - $280000 annually. 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.