Manager, Clinical Study Start Up

Summit Therapeutics plc•Menlo Park, CA

31d•$118,500 - $139,000•Onsite

About The Position

About Summit Ivonescimab known as SMT112 is a novel potential first in class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD 1 with the anti angiogenesis effects associated with blocking VEGF into a single molecule Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD 1 and VEGF Summit has begun its clinical development of ivonescimab in non small cell lung cancer NSCLC with three active Phase III trials HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR mutated locally advanced or metastatic non squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI eg osimertinibHARMONi 3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first line metastatic NSCLCHARMONi 7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first line metastatic NSCLC whose tumors have high PD L1 expressionIvonescimab is an investigational therapy that is not approved by any regulatory authority in Summits license territories including the United States and Europe Ivonescimab was approved for marketing authorization in China in May 2024 Ivonescimab was granted Fast Track designation by the US Food & Drug Administration FDA for the HARMONi clinical trial setting Overview of Role We are seeking an experienced and highly motivated Manager to join our team This role is crucial in managing site agreements to support our programs The ideal candidate will have extensive experience in site contract and budget negotiation as well as 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

Requirements

Bachelors degree in Life Sciences Business Administration or related field required
A minimum of 4 years experience with clinical trial site agreements in biotech or pharmaceutical setting
Experience in clinical operations andor study start up
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 or similar benchmarking tool
Expertise in large multi site clinical trials with multiple vendor types is preferred
Direct negotiating with sites and vendors is a must
Good understanding of the clinical process is important
Proficient user of standard MS Office suite eg 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 skills
Critical thinking problem solving ability to work independently
Must be able to effectively multi task and manage time sensitive and highly confidential documents
Prioritize conflicting demands
Work in a fast paced demanding and collaborative environment
Knowledge of GCP guidelines and relevant regulatory requirements

Nice To Haves

Experience in oncology is highly desirable
Strong global negotiation and contract management skills

Responsibilities

Under minimal guidance develop 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 knowledge 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 study 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
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 innovative ideas and solutions to increase the efficiency of the department
All other duties as assigned