Senior Director, Regulatory Affairs Advertising & Promotion
Summit TherapeuticsAbout the role
About Summit:
Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence.
Summit’s team is inspired to touch and help change lives through Summit’s clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including:
Non-small Cell Lung Cancer (NSCLC)
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HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI.
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HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.
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HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC.
Colorectal Cancer (CRC)
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HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.
Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.
Overview of Role:
The Senior Director is responsible for reviewing materials submitted to the Medical Review Committee (MRC) as well as those submitted to Summit’s Promotional Review Committee (PRC), in accordance with applicable regulations, guidance documents, and internal policies/SOPs.
Role and Responsibilities:
- Accountable for evaluating all perspectives (Commercial, Legal/Compliance, Medical) and provide expert regulatory guidance for promotional, disease state education, corporate and other non-promotional materials for relevant products and associated therapeutic areas to cross-functional teams.
- Review materials in Veeva and actively participate in MRC and PRC meetings.
- Review and interpret enforcement actions, keeping current with industry changes relating to advertising and promotion, interpreting new FDA Guidance to Industry documents, and, as applicable, evaluating related internal policies/best practices and processes.
- Contribute to implementing internal MRC/PRC processes to ensure all materials comply with FDA regulations.
- Provide regulatory guidance on overall process enhancements to ensure compliance and process efficiencies.
- Develop and implement regulatory ad promo strategy and managing complex negotiations with internal and external stakeholders.
- Providing guidance on communications with HCPs, patients/consumers, payers, executive management, and other internal and external audiences.
- Facilitate the submission of branded promotional materials to FDA on Form 2253.
- Act as the main point of contact with FDA's Office of Prescription Drug Promotion.
- Advises management and cross-functional team members of the effect of current or proposed relevant laws, regulations, guidelines, and standards, etc.
- Accountable for ensuring that corporate goals are met with respect to assigned projects.
- Acts independently under direction of Vice President of Regulatory Affairs, with the Senior Director Ad Promo expected to represent regulatory with little to no oversight.
- May have direct reports and contributes to the performance management for other RA team members.
- May advance the organization's goals by participating and taking leadership roles in professional associations, industry, and trade groups as appropriate.
- Follow budget allocations.
Experience, Education and Specialized Knowledge and Skills:
- Bachelor's degree in scientific discipline and 12+ years of related experience, or the equivalent combination of education and experience.
- An advanced degree (MS, PharmD) is preferred.
- Strong Regulat
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