Therapeutic Area Head, Clinical Development

*This position will be located on-site in Menlo Park CA / Princeton NJ / or Miami FL

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:

The Therapeutic Area Head Clinical Development will be primarily responsible for developing and executing an integrated strategy and clinical trial program for a specific therapeutic area in oncology. Proposed areas include but are not limited to gastrointestinal (GI) oncology breast oncology head and neck oncology (HNSCC) and genitourinary oncology (GU).

The incumbent will be responsible for providing clinical expertise obtaining scientific advisory input from external experts working cross-functionally to develop clinical studies supporting regulatory interactions for product advancement and partnering with the operations team to provide advice and decision making regarding medical input to achieve operational excellence. The incumbent must be a recognized expert in a therapeutic area in oncology have demonstrated effective collaborative skills to work across various phases of clinical development and serve as a key medical expert for multiple cross functional teams. Investigator engagement including travel to support face-to-face interaction and protocol training is a vital component of this role. Prior experience in a mid-sized fast-growing pharmaceutical environment is preferred as this role will be working on product development in a fast-paced and intense environment.

The Therapeutic Area Head will serve as a leader on one or more potentially pivotal programs reporting directly into the Chief Medical Officer.

Role and Responsibilities:

• Significant oncology experience: the role will require expertise in the treatment and management of oncology disease such that knowledge can be applied to the strategy and clinical development of Summit medicines to benefit patients
• Established network and relationships with oncology experts investigators and opinion leaders
• Work cross functionally with Medical Affairs Regulatory Commercial and other functions to develop the overall product strategy in multiple indications
• Work cross functionally with Clinical Operations Biometrics Pharmacovigilance and other functions to successfully complete clinical development programs leading to BLA approvals
• Lead teams to execute on clinical development goals (clinical trial execution clinical development strategy medical affairs planning)
• Manage direct reports or cross functional team members as needed based on team needs
• Contribute to the communication strategy of Summit products via publications manuscripts abstracts posters and scientific presentations
• Make vital contributions and leading 1-2 pivotal programs in clinical development program.
• Direct human clinical trials phases 1-3 for lead candidate in development helping to ensure all clinical development milestones are met including enrollment goals
• Participate in medical review of adverse event reports and monitoring of incoming safety data in conjunction with product safety/pharmacovigilance including evaluating and escalating safety signals
• Coordinate and develop information for reports submitted to FDA EMA PMDA and government regulatory or partner agencies
• Present to various external stakeholders - regulators governing and harmonization bodies principal investigators scientific conference attendees advisors and opinion leaders.
• Maintain knowledge of clinical trial conduct to support operational needs for planning and executing clinical trials including adherence to protocols safety reviews assay development training and clinical document review
• Plan reviewing and editing Clinical Study Reports
• Plan reviewing and editing publications from the program
• Provide input on the design of clinical studies supporting clinical strategy
• All other duties as assigned

Experience Education and Specialized Knowledge and Skills:

• Board certified or eligible MD with hematology/oncology product development and experience across stages of clinical development
• 10 years experience in university pharmaceutical industry academic or biotech R&D environment or in a research environment involving the collection and analysis of human data in the area of hematology/oncology
• Working knowledge of clinical development pathways for hematology/oncology therapeutics in the US and EMEA
• Self-starter who will move forward with key initiatives without being prompted able to perform a myriad of tasks needed to support the clinical development program possesses a highly entrepreneurial and growth mindset works collaboratively with cross-functional teams loves a good mission
• Ability to lead a dynamic team and work in a fast-paced hands-on and changing environment
• Clear and provable evidence of effective leadership skills

The pay range for this role is $344000-$430000 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.

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