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You will be updated with latest job alerts via email$ 118500 - 139500
1 Vacancy
THIS POSITION WILL BE ONSITE IN: San Francisco Bay Area (Menlo Park)
*Relocation support will be considered for this role
About Summit:
Ivonescimab known as SMT112 is a novel potential firstinclass investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD1 with the antiangiogenesis 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 PD1 and VEGF.
Summit has begun its clinical development of ivonescimab in nonsmall 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 EGFRmutated locally advanced or metastatic nonsquamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g. osimertinib).
HARMONi3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with firstline metastatic NSCLC.
HARMONi7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with firstline metastatic NSCLC whose tumors have high PDL1 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:
The Medical Legal & Regulatory (MLR)/Publications Manager will play a crucial role in overseeing various compliancerelated processes within the organization. While the primary focus will be on ensuring that all promotional and nonpromotional materials comply with internal policies and external regulations this role may also involve coordinating and supporting other medical affairs activities such as publications. The MLR/Publications Manager will facilitate communication between crossfunctional teams manage timelines and ensure timely approvals and documentation of materials and processes contributing to the overall regulatory and operational efficiency of the company. This position will report to the Director Medical Communications & Information and will be on site in Menlo Park CA.
Role and Responsibilities for MLR:
Role and Responsibilities for Publications:
Experience Education and Specialized Knowledge and Skills:
The pay range for this role is $118500$139500 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 at to obtain prior written authorization before referring any candidates to Summit.
Required Experience:
Manager
Full-Time