Job Description

Summit is seeking a highly skilled and experienced Medical Affairs Director to lead the medical strategy and tactical execution for the development and launch of ivonescimab in lung-related indications.

About Ivonescimab : 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.

Key Responsibilities : The successful candidate will be responsible for leading the medical strategy for the launch of ivonescimab in lung-related indications, developing and implementing pre-launch disease and product education programs, and ensuring the medical strategy and its execution align with regulatory requirements.

• Drug Launch Leadership: Lead the medical strategy for the launch of ivonescimab in lung-related indications.
• Pre-Launch Education: Develop and implement pre-launch disease and product education programs for healthcare professionals, patients, and other stakeholders.
• Medical Strategy Development: Develop and implement medical strategies for ivonescimab in lung-related indications.
• Regulatory and Compliance Alignment: Work closely with regulatory affairs to ensure compliance with all regulatory requirements.
• Stakeholder Engagement: Build and maintain relationships with key opinion leaders, healthcare professionals, and other stakeholders.
• Data Analysis and Interpretation: Analyze and interpret clinical data to provide medical insights and support decision-making processes.
• Cross-Functional Collaboration: Collaborate with cross-functional teams to ensure the medical strategy supports commercial objectives.
• Medical Information: Provide accurate and up-to-date medical information to internal and external stakeholders.
• Compliance: Ensure all activities are conducted in compliance with relevant laws, regulations, and company policies.

Experience, Education, and Specialized Knowledge and Skills : The ideal candidate will have an MD, PhD, or PharmD, with a minimum of 10+ years of oncology-related experience in a medical affairs or combination of medical affairs and clinical development role.

• Oncology drug launch experience required; lung cancer launch experience is highly preferred.
• Proven track record in leading medical strategies and supporting launch and on-market oncology therapies.
• Strong analytical and problem-solving skills with the ability to interpret complex scientific data.
• Excellent communication and collaboration skills.

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