Senior Medical Director

🕒 October 14

🇺🇸 United States – Remote

💵 $237k - $296k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

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Summit Therapeutics, Inc.

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2003

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Summit Therapeutics, Inc. is a biopharmaceutical oncology company focused on the discovery, development, and commercialization of innovative medicinal therapies aimed at improving quality of life for oncology patients. The company is particularly committed to addressing serious unmet medical needs through its lead investigational therapy, ivonescimab, a novel bispecific antibody designed to target both PD-1 and VEGF. Summit’s initiatives include ongoing Phase III clinical trials to evaluate ivonescimab's effectiveness in treating non-small cell lung cancer, highlighting their dedication to patient-centered care and technological advancement in the field of oncology.

📋 Description

• Provide medical affairs and clinical development leadership, including medical oversight of clinical studies • Obtain scientific advisory input and work with external clinical investigators • Support regulatory interactions for product advancement • Collaborate with clinical operations on medical input and operational decision-making • Serve as a key medical expert for multiple cross-functional teams • Apply oncology treatment and management expertise to Summit medicines’ strategy and clinical development • Develop overall product strategy across multiple indications with Medical Affairs, Regulatory, Commercial, and other functions • Collaborate with Clinical Operations, Biometrics, Pharmacovigilance, and other functions to complete clinical development programs leading to BLA approvals • Lead clinical trial execution, clinical development strategy, and medical affairs planning • Contribute to product communications through publications, manuscripts, abstracts, posters, and scientific presentations • Contribute to two or more pivotal clinical development programs • Direct Phase 1–3 human clinical trials and help achieve development milestones and enrollment goals • Review adverse event reports and monitor safety data, evaluating and escalating safety signals • Coordinate information for reports submitted to FDA, EMA, PMDA, government, regulatory, or partner agencies • Present to regulators, governing and harmonization bodies, principal investigators, scientific conferences, advisors, and opinion leaders • Support clinical trial planning and execution, including protocol adherence, safety reviews, assay development, training, and clinical document review • Plan, review, and edit Clinical Study Reports • Plan, review, and edit program publications • Provide input on clinical study design supporting clinical strategy • Perform other duties as assigned

🎯 Requirements

• Board certified or eligible MD with hematology/oncology product development experience across stages of clinical development • Minimum of 5+ years’ experience in a pharmaceutical, biologics, or biotech R&D environment, or research environment involving collection and analysis of human data in hematology/oncology • Working knowledge of clinical development pathways for hematology/oncology therapeutics in the US and EMA • Fluent in English and at least one or more other European languages (French, Spanish, German, Italian, etc.) • Proficient user of standard MS Office suite, such as Word and Excel • Experience using electronic document management systems and document review tools desirable • Strong computer and database skills • Attention to detail, accuracy and confidentiality • Clear and concise oral and written communication skills • Excellent organizational skills • Critical thinking, problem solving, and ability to work independently • Ability to multitask and manage time-sensitive and highly confidential documents • Ability to communicate complex ideas clearly • Ability to prioritize conflicting demands • Ability to work in a fast-paced, demanding, and collaborative environment • Willingness and ability to travel for investigator engagement, face-to-face interaction, and protocol training

🏖️ Benefits

• Potential bonus • Stock • Benefits • Variable compensation may be included in the total compensation package • Remote work arrangement

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