Director, Clinical Pharmacology & DMPK

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 Summit’s 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:

Manage clinical pharmacology data analysis and modelling support for Summit’s assets. Responsible for PK and PKPD data analysis to support projects.

 

Role and Responsibilities:

• Contribute to clinical development by supporting early and late-stage clinical studies with data analysis, modeling and simulation evaluations to guide study design, and clinical pharmacology strategy

• Conduct data analyses including non-compartmental analysis, complex PK analysis, population PK and PK/PD analyses, modeling and simulation (e.g., exposure-response, dose optimization, meta-analysis)

• Accountable for developing model-informed drug development using quantitative approaches to address scientific questions arising during drug development

• Interprets and presents Clinical Pharmacology and DMPK scientific data/results to the team

• Participate and present at various departmental and cross functional teams

• Write, review, and edit regulatory documents including analysis plans, study reports, population PK reports, exposure-response analyses reports, common technical documents, and other similar documents, and respond to queries from regulatory agencies

• All other duties as assigned

Experience, Education and Specialized Knowledge and Skills:

 

• Ph.D., Pharm.D., or equivalent training in Pharmacokinetics, Pharmaceutical sciences, Biostatistics, or related disciplines with a minimum of 5+ years of clinical pharmacology industry experience or M.S. with 8+ years of relevant experience

• Hands-on experience with standard PK Software (e.g., Phoenix WinNonlin)

• Demonstrate computational skills related to pharmaceutical or biomedical research with hands-on programming skills in SAS, R, MATLAB; experiences with population PK analysis and PKPD modeling tools (e.g., NONMEM, and other modeling platforms) are required.

• Detail-oriented, highly organized, and able to manage multiple tasks

• Strong project manag