Associate Director, Clinical Study Start-Up

Job description

**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:** 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 8+ 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