Manager, Global Medical Affairs Operations - Contract

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.* **Manager, Global Medical Affairs** **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 Manager, Medical Affairs Operations will support the planning, coordination, and execution of operational activities across the Global Medical Affairs function. This role will help ensure that Medical Affairs initiatives are delivered on time, within scope, and in alignment with company policies, compliance requirements, and business priorities. The Manager will support cross-functional coordination, documentation, meeting logistics, and operational reporting across activities such as congress planning, advisory boards, patient advocacy initiatives, and other key Global Medical Affairs projects. **Role and Responsibilities:** - Support day-to-day operational planning and coordination for Medical Affairs activities, ensuring timelines, deliverables, and dependencies are clearly tracked and communicated. - Assist with the execution of congress planning, advisory boards, patient advocacy initiatives, medical education activities, field medical support, and other Medical Affairs projects. - Coordinate cross-functional meetings, capture action items, and follow up with stakeholders to support timely completion of agreed deliverables. - Maintain project trackers, dashboards, calendars, and other operational tools to provide visibility into Medical Affairs activities, milestones, budgets, and risks. - Maintain accurate documentation, shared files, meeting records, trackers, and reports to support transparency, audit readiness, and operational continuity. - Contribute to the development, refinement, and implementation of Medical Affairs operational processes, templates, work instructions, and best practices. - Support metrics tracking and reporting to help leadership monitor project progress, budget status, operational performance, and areas for improvement. - Partner with internal stakeholders, external vendors, and field medical colleagues to facilitate clear communication and coordinated execution of Medical Affairs initiatives. - Identify operational issues, risks, or process gaps and escalate appropriately to the Associate Director, Medical Affairs Operations. - Perform all other duties as assigned in support of Medical Affairs Operations and evolving business needs. **Experience, Education and Specialized Knowledge and Skills:** - Bachelor’s degree in Life Sciences, Healthcare, Business Administration, or a related field required; advanced degree or project management certification is a plus. - 3+ years of experience in Medical Affairs, Clinical Operations, Project Management, Compliance, or a related operational role within the pharmaceutical, biotechnology, healthcare, or life sciences industry. - Experience supporting Medical Affairs activities such as congress planning, advisory boards, sponsorships, vendor management, contracts, medical communications, or launch readiness preferred. - Strong organizational and project coordination skills, with the ability to manage multiple priorities, track details accurately, and meet deadlines in a fast-paced environment. - Excellent written and verbal communication skills, with the ability to interact effectively with internal colleagues, external vendors, and cross-functional partners. - Proficiency with Microsoft Office applications and experience using project management, collaboration, document management, budgeting, or review systems preferred. - Familiarity of developing and managing Smartsheets for tracking all projects a plus - Working knowledge of pharmaceutical industry compliance requirements, including FMV, Sunshine Act, and appropriate documentation standards preferred. - Familiarity with medical terminology, oncology, clinical research, or pre-launch and launch activities is a plus. - Demonstrated attention to detail, discretion with confidential information, sound judgment, and ability to work both independently and collaboratively. - Proactive, flexible, and solutions-oriented, with a strong interest in operational excellence and continuous improvement within Medical Affairs. 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.