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.#J-18808-Ljbffr