Senior Director, Regulatory Affairs Advertising & Promotion

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)

• 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.

• 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.

• 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)

• 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 Regulatory Ad Promo knowledge.
• Demonstrated success in the preparation and submission of regulatory documents.
• Strong understanding of the role of Ad Promo and the regulatory requirements for the promotion of prescription drugs.
• Experienced user of the Veeva ecosystem as relates to review and submission of PRC-related items.
• Strong communication and proactive negotiation skills.
• Communicate effectively and articulate complex ideas in an easily understandable way.
• Ability to successfully work in a fast-paced, demanding and collaborative environment.
• Travel up to approximately 5%.

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 Summit’s Talent Acquisition team at recruiting@smmttx.com to obtain prior written authorization before referring any candidates to Summit.

Summit Therapeutics Inc. is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. We do not discriminate in recruitment, hiring, training or promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.