Director, Clinical Study Start-Up

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.

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:

We are seeking an experienced and highly motivated Associate Director to join our team. This role is crucial in managing site agreements to support our programs. The ideal candidate will have extensive experience in clinical outsourcing, site contract and budget negotiation, and managing relationships with clinical research sites. You will support clinical benchmarking and site budget development, escalation, and payment activities for the Clinical Operations department. You will partner with functional leads of departments to establish strategic approaches to fair market value negotiations and enable site activations.

Role and Responsibilities:

• Under minimal guidance, lead the development of pricing strategies for site budgets to enable contract execution and site activation
• Collaborate with legal, finance, CRO and clinical teams to ensure site agreements comply with regulatory and company standards
• Negotiate and finalize site agreements, including budgets, contracts, and other necessary documentation. Knowledge of CTA legal risks and possible fallback language required.
• Rigorous analysis of budgets with the goal of securing the best price
• Confidently present the budget to the Chief Accounting Officer for approval, ensuring full knowledgeable of all details
• Partner with Clinical Finance team to provide study-wide site payment estimates and forecasts
• Work with legal counsel to ensure appropriate indemnification, liability, and confidentiality provisions are included in contracts
• Provide regular updates to management on progress and key performance indicators related to trial agreements
• Work with Finance and Clinical Leadership as needed to address budget, invoice, payment, and PO concerns
• Collaborate with external functional service providers (FSP) on site budget templates, study-level work orders and POs, and site payment processes
• Build and maintain strong relationships with CROs, FSP providers, and clinical sites
• Monitor FSP providers and ensure adherence to project timelines, quality standards, and contractual obligations
• Identify and implement departmental processes or standards
• Assist and work with senior management on special projects
• Develop and maintain outsourcing strategies to support clinical trials across various phases
• Ensure timely and cost-effective solutions that meet project timelines and budgets
• Address and resolve any issues or disputes related to site agreements
• Collaborate with internal stakeholders, such as Legal, Clinical Operations and Clinical Development
• Develop and implement new ideas and solutions to increase the efficiency of the department
• All other duties as assigned

Experience, Education and Specialized Knowledge and Skills:

• Bachelor's degree in Life Sciences, Business Administration or related field required
• A minimum of 10+ years' experience with clinical trial site agreements in biotech or pharmaceutical setting
• Experience in oncology is highly desirable
• Strong global negotiation and contract management skills
• Experience in clinical finance, business development, or clinical operations
• Strong financial acumen and ability to understand and create budgets
• Experience working with site budgets on a global scale, and potential internal escalation pathway
• Strong knowledge of using grant plan
• Expertise in large, multi-site, clinical trials with multiple vendor types is required
• The ideal candidate will have experience working with departments that have established processes in place
• Direct experience vetting and negotiating with sites and vendors is a must
• Good understanding of the clinical process is important
• Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools desirable
• Strong computer and database skills
• Attention to detail, accuracy and confidentiality
• Clear and concise oral and written communication skills
• Excellent communication, interpersonal and organizational skill
• Critical thinking, problem solving, ability to work independently
• Must be able to effectively multi-task and manage time-sensitive and highly confidential documents
• Communicate effectively and articulate complex ideas in an easily understandable way
• Work in a fast-paced, demanding and collaborative environment
• Knowledge of GCP guidelines and relevant regulatory requirements

This is the pay for this position

Pay Transparency

$203,000 - $253,000 USD

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 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.

As set forth in Summit Therapeutics’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.