Head of Europe, Middle East & Africa (EMEA)

Job description

**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:** We are seeking an experienced leader to establish and lead our European, Middle East and Africa organization as we prepare to expand globally. With our first three launches focused on lung cancer, this leader will build the team, capabilities, and infrastructure needed to bring our therapies to patients and establish a sustainable business in Europe, the Middle East and Africa. The Head of EMEA General Manager will have overall accountability for EMEA strategy, operations, financial performance, and launch execution, overseeing day-to-day operations of all functions including, Commercial, Medical Affairs, Market Access, Regulatory Affairs, Clinical Operations, Pharmacovigilance, Quality, Supply Chain, Legal, Compliance, and other regional support functions. The leader will partner closely with global functional heads to align regional execution and Company priorities. The role will operate in a dynamic, precommercial biotechnology environment. The successful candidate must be comfortable building capabilities with limited precedent, balancing regional needs with global priorities, and moving between strategy and execution. The role requires significant travel and regular collaboration across time zones. **Role and Responsibilities:** - Develop in partnership with global functional heads the EMEA expansion strategy, including market prioritization, country entry sequencing, operating model, partnerships, and investment plans. - Own the EMEA profit and loss statement, budgets, forecasts, and resource allocation, balancing launch readiness, patient access, and long-term growth. - Translate global strategy into regional and country plans with clear milestones, measures of success, and accountability; communicate progress, risks, and investment needs to executive leadership. - Build the EMEA organization from the ground up, recruiting and developing regional functional leaders and country general managers as the business scales. - Partner with global teams to establish the entities, infrastructure, systems, policies, and external service providers needed to operate effectively across Europe, the Middle East and Africa. - Lead integrated readiness and execution for the launches, coordinating medical, regulatory, market access, commercial, and supply activities across priority countries. - Determine the appropriate mix of direct capabilities, distributors, agents, and third-party partners by market, and establish rigorous selection, contracting, oversight, and performance-management processes. - Ensure regional activities are conducted in accordance with applicable local requirements, Company standards, and global quality and compliance expectations. Oversee country launch plans, including positioning, market development, field deployment, distribution, and performance measures, informed by treatment landscape and local patient pathways. - Direct EMEA pricing, reimbursement, and market access strategy, partnering with global teams on health technology assessments, evidence requirements, payer engagement, and country negotiations. - Ensure Medical Affairs develops scientific engagement, and evidence plans to address the needs of clinicians and patients, with appropriate independence from commercial decision-making. - Oversee regional regulatory, clinical, safety, quality, and supply activities in partnership with global functional leaders, supporting clinical development, reliable product availability, and appropriate post-launch capabilities. - Ensure an effective compliance framework, ethical business practices, and timely escalation of issues across EMEA operations; protect the independence and authority of designated regulatory, safety, quality, medical, and compliance personnel. - Represent the Company with healthcare stakeholders, potential partners, industry organizations, and other external audiences; build trusted relationships across the EMEA oncology community. - All other duties as assigned **Experience, Education and Specialized Knowledge and Skills:** - Advanced degree in business, life sciences, medicine, pharmacy, or a related discipline required. - A minimum of 15+ years of progressive leadership experience in the biotechnology or pharmaceutical industry, oncology experience preferred. - Demonstrated success establishing a new affiliate, country organization, business unit, or regional operation from inception through launch or commercialization. - Meaningful leadership experience in EMEA, preferably across multiple broader regional markets, with a strong understanding of local healthcare systems, cultures, business practices, and public- and private-sector dynamics. - Working knowledge of regional health authorities, regulatory and registration processes, pricing and reimbursement, tender and procurement models, distribution requirements, and pharmaceutical compliance expectations. - Successful track record leading a cross-functional product launch or major launch-readiness effort; experience in a precommercial or high-growth biotech environment strongly preferred. - Experience selecting and managing distributors, agents, vendors, or strategic partners and establishing appropriate third-party governance. - Demonstrated ability to build and lead diverse, high-performing teams while operating effectively within a global matrix. - Strong financial and analytical capability, including business-case development, forecasting, budgeting, resource allocation, and pe Strong leadership, communication, and external relationship skills; sound judgment and a demonstrated commitment to ethical conduct and patient needs. - Ability to influence global strategy, make sound investment decisions, and execute with limited infrastructure in a fast-moving organization. - Fluency in English required; additional European languages, as well as Arabic preferred. Willingness to travel extensively within Europe, Middle East and Africa and internationally. 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](mailto: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.