Director, Medical Affairs Operations
Summit Therapeutics · Princeton, New Jersey, United States
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 Director, Medical Affairs Operations will lead the global Medical Affairs Operations function and provide strategic oversight for the execution of operational activities that support Medical Affairs strategy across regions. This role serves as a key business partner to Medical Affairs leadership and collaborates closely with Compliance, Legal, Finance, Clinical Development, and external vendors to ensure consistent, compliant, and efficient execution of congress sponsorships, advisory boards, scientific engagement programs, healthcare professional interactions, vendor management, contracting, budgeting, systems, and operational excellence initiatives. The Director will establish scalable processes, drive global alignment, manage vendor relationships, build operational capabilities, and oversee a global team supporting Global Medical Affairs operations, while supporting launch readiness, organizational growth, and the successful execution of strategic initiatives across the Medical Affairs organization.
Responsibilities
- Global Medical Affairs Operations Leadership: Lead operational planning and execution of Medical Affairs initiatives across regions, therapeutic areas, and functions. Establish scalable frameworks, policies, processes, and best practices that improve efficiency, quality, compliance, and organizational readiness.
- Team Leadership and Development: Lead, coach, and develop a high-performing global Medical Affairs Operations team, including congress sponsorship, US operations, and Europe-based operations roles. Establish goals, performance objectives, development plans, and operating rhythms that support team effectiveness and future growth.
- Cross-Functional Partnership and Governance: Partner with regional Medical Affairs leaders, Compliance, Legal, Regulatory Affairs, Finance, Procurement, Clinical Development, IT, and external vendors. Ensure consistent execution of operational processes worldwide and act as an escalation point for operational challenges and cross-functional issue resolution.
- Vendor and Financial Management: Oversee Medical Affairs vendor strategy, selection, contracting, performance management, SOWs, purchase orders, budgets, forecasting, and invoice reconciliation. Partner with Finance and Procurement to optimize resource utilization and ensure external engagements follow FMV requirements, company policies, and industry standards.
- Congress, Advisory Board, and Scientific Engagement Operations: Provide oversight for national, regional, and international congress sponsorships, exhibits, medical booths, scientific exchange activities, advisory boards, investigator meetings, and individual customer engagements. Establish standardized planning processes, operational metrics, vendor oversight, and resource plans to support consistent execution across regions.
- Compliance and Operational Risk Management: Ensure Medical Affairs operations adhere to healthcare compliance requirements, Sunshine Act reporting obligations, FMV standards, company policies, and applicable industry regulations. Maintain audit-ready documentation, monitor emerging requirements, and identify operational risks with appropriate mitigation plans.
- Systems, Metrics, and Analytics: Lead development and implementation of dashboards, reports, KPIs, and operational metrics to measure program effectiveness, congress investments, vendor performance, and operational activities. Partner with IT and Digital teams to implement systems and use analytics to identify process improvements and resource allocation opportunities.
- Strategic Planning and Launch Readiness: Support annual planning, budget planning, long-range Medical Affairs operational strategy, pipeline expansion, and new product launch readiness. Develop resource and infrastructure plans that enable growth across regions, functions, and therapeutic areas.
Experience, Education and Specialized Knowledge and Skills:
- Bachelor's degree in Life Sciences, Healthcare, Business Administration, or related field required.
- Advanced degree (MS, MBA, MPH, PharmD, or equivalent) preferred.
- 10+ years of experience in Medical Affairs Operations, Clinical Operations, Commercial Operations, or related pharmaceutical/biotech functions.
- Minimum 5 years of people management experience.
- Oncology experience strongly preferred.
- Experience supporting both US and international Medical Affairs organizations preferred.
- Demonstrated experience supporting pre-launch and launch-stage organizations.
- Proven experience managing complex vendor relationships, operational budgets, and cross-functional initiatives.
- Strong leadership and team development capabilities.
- Excellent project and portfolio management skills.
- Deep understanding of healthcare compliance requirements, FMV processes, Sunshine Act reporting, and contracting practices.
- Strong financial and budget management expertise.
- Ability to operate effectively in a fast-paced, matrixed biotech environment.
- Experience implementing operational systems, dashboards, and process improvement initiatives.
- Strong analytical and problem-solving skills with a focus on operational excellence.
This is the pay for this position
Pay Transparency$190,000—$237,000 USD
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.
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