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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 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. This role is pivotal in developing comprehensive pre, peri, and post-launch medical activities, including disease and product education, strategic publications, data generation, stakeholders engagement, and other programs and oversee their execution through the team. The successful candidate will ensure the medical strategy, and its execution aligns with regulatory requirements and supports the successful commercialization of ivonescimab.

Key Responsibilities:

• Drug Launch Leadership: Lead the medical strategy for the launch of ivonescimab in lung-related indications. Develop and execute a comprehensive launch plan, including pre-launch activities, stakeholder engagement, and post-launch support.
• Pre-Launch Education: Develop and implement pre-launch disease and product education programs for healthcare professionals, patients, and other stakeholders. Create training materials, presentations, and educational content to ensure a thorough understanding of ivonescimab and its therapeutic benefits.
• Medical Strategy Development: Develop and implement medical strategies for ivonescimab in lung-related indications, ensuring alignment with overall business objectives.
• Regulatory and Compliance Alignment: Work closely with regulatory affairs to ensure compliance with all regulatory requirements and support the preparation of regulatory submissions.
• Stakeholder Engagement: Build and maintain relationships with key opinion leaders, healthcare professionals, and other stakeholders to support the successful launch and adoption of ivonescimab.
• 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, including marketing, sales, and market access, 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:

• MD, PhD, or PharmD required
• Oncology drug launch experience required; lung cancer launch experience is highly preferred[LS1]
• Minimum of 10+ years of oncology related experience in a medical affairs or combination of medical affairs and clinical development role; minimum of 7+ years of experience in a lung cancer
• 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. With ability to demonstrate prior success in working with commercial departments.
• Ability to work independently and as part of a team.
• Detail-oriented with strong organizational skills.
• Demonstrated ability to interact with senior management, academic experts, and patient advocates appropriately, with confidence and ease.
• Domestic and international travel required, expected to be 20-30% of the time and as needed.
• Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools.
• Must be able to effectively multi-task and manage time-sensitive and highly confidential documents.
• Work in a fast-paced, demanding, and collaborative environment.

The pay range for this role is $230,000-$288,500annually. 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 atrecruiting@smmttx.com to obtain prior written authorization before referring any candidates to Summit.

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