Manager, Clinical Study Start Up (Contract)

*THIS IS A TEMPORARY 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 (e.g. osimertinib).

• HARMONi-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 NSCLC.

• HARMONi-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 expression.

Ivonescimab 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.

Role and 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

Experience Education and Specialized Knowledge and Skills:

• 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 oncology is highly desirable
• Strong global negotiation and contract management skills
• Experience in clinical operations and/or 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 (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 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

The pay range for this role is $50-$60 per hour. 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.