Senior Director, Regulatory Affairs Advertising & Promotion
Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on improving quality of life, increasing potential duration of life, and addressing serious unmet medical needs. Our team of world-class professionals is passionate about this mission, driving it forward with integrity, excellence, collaboration, and urgency. Summit’s employees are central to our culture and play a key role in advancing our clinical studies in oncology.
Summit is currently conducting multiple global Phase 3 clinical studies, including:
- Non-small Cell Lung Cancer (NSCLC):
- HARMONi: Evaluates ivonescimab combined with chemotherapy vs. placebo plus chemotherapy in EGFR-mutated, locally advanced or metastatic non-squamous NSCLC (previously treated with a 3rd generation EGFR TKI).
- HARMONi-3: Evaluates ivonescimab combined with chemotherapy vs. pembrolizumab combined with chemotherapy in first-line metastatic NSCLC.
- HARMONi-7: Evaluates ivonescimab monotherapy vs. pembrolizumab monotherapy in first-line metastatic NSCLC.
- Colorectal Cancer (CRC):
- HARMONi-GI3: Evaluates ivonescimab in combination with chemotherapy vs. bevacizumab plus chemotherapy.
Ivonescimab is an investigational therapy currently approved only by China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, with additional offices in California, New Jersey, the UK, and Ireland.
About the Role
The Senior Director is responsible for reviewing materials submitted to the Medical Review Committee (MRC) and Promotional Review Committee (PRC), ensuring compliance with applicable regulations, guidance documents, and internal policies/SOPs.
Responsibilities
- Evaluate 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 therapeutic areas.
- Review materials in Veeva and actively participate in MRC and PRC meetings.
- Interpret enforcement actions, stay current with industry changes relating to advertising and promotion, and evaluate new FDA Guidance to Industry documents and related internal policies/best practices.
- Contribute to implementing internal MRC/PRC processes to ensure compliance with FDA regulations.
- Provide regulatory guidance on process enhancements for compliance and efficiency.
- Develop and implement regulatory ad promo strategy and manage complex negotiations with internal and external stakeholders.
- Provide guidance on communications with HCPs, patients/consumers, payers, executive management, and other internal and external audiences.
- Facilitate the submission of branded promotional materials to the FDA on Form 2253.
- Act as the main point of contact with FDA’s Office of Prescription Drug Promotion.
- Advise management and cross-functional teams on the impact of current or proposed laws, regulations, guidelines, and standards.
- Ensure corporate goals are met for assigned projects, acting independently under the direction of the Vice President of Regulatory Affairs.
- May manage direct reports and contribute to performance management for other Regulatory Affairs team members.
- Participate in and take leadership roles in professional associations, industry, and trade groups as appropriate.
- Follow budget allocations.
- Travel up to approximately 5%.
Requirements
- Bachelor’s degree in a scientific discipline and 12+ years of related experience, or an equivalent combination of education and experience.
- An advanced degree (MS, PharmD) is preferred.
- Strong Regulatory Ad Promo knowledge.
- Demonstrated success in preparing and submitting regulatory documents.
- Strong understanding of the role of Ad Promo and regulatory requirements for prescription drug promotion.
- Experienced user of the Veeva ecosystem for review and submission of PRC-related items.
- Strong communication and proactive negotiation skills.
- Ability to articulate complex ideas clearly and work effectively in a fast-paced, collaborative environment.
Pay
$217,000 - $271,000 USD. Actual compensation is based on factors unique to each candidate, including skill set, depth of experience, certifications, and work location. The total compensation package may also include bonus, stock, benefits, and other variable compensation.