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Summit Therapeutics

Senior Director, Regulatory CMC

$153K - $202K/yr

Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on ... management of biologic products. * Represent Regulatory CMC at the senior project team and ...

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Summit is a company that values collaboration and innovation, fostering a dynamic and supportive work environment where employees can share ideas and expertise.

The company's structure is designed to encourage teamwork and open communication, with a flat organizational hierarchy and regular cross-functional meetings. Summit's mission is to develop cutting-edge technologies that drive positive change, and employees are encouraged to contribute to this mission through various projects and initiatives.

Working at Summit may appeal to candidates who are passionate about technology and social impact, as the company offers opportunities for professional growth, skill development, and collaboration with a diverse and talented team.

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Summit is a well-established company in its industry, known for its commitment to innovation and customer satisfaction. The company's work environment is characterized by a collaborative culture, opportunities for professional growth, and a stable work-life balance. Joining Summit offers employees the chance to contribute to meaningful projects, develop their skills, and be part of a dynamic team that values teamwork and employee development.

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Infographic showing various Summit Risk Manager job openings at Summit in the United States as of September 2026, with employment types broken down into 70% Full Time, and 30% Part Time. Highlights an 96% Physical, 1% Hybrid, and 3% Remote job distribution.

Senior Manager, Medical Affairs Operations

Palo Alto, CA • On-site

Summit Therapeutics
See more jobs at Summit Therapeuticsexternal

Full-time

Posted 20 days ago

Key responsibilities

  • Lead operational planning and execution of Medical Affairs congress sponsorship activities.

  • Manage sponsorship applications, agreements, vendor coordination, and related documentation.

  • Coordinate with internal teams and external partners to ensure timely and compliant congress activities.

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:
The Senior Manager, Medical Affairs Operations is responsible for the operational planning, execution, and oversight of Medical Affairs congress sponsorship activities. This role serves as the primary operational lead for national, regional, and international congress engagements, ensuring gathering of congress sponsorships needs, timely execution of sponsorship agreements, vendor management, budgeting, compliance requirements, and onsite logistics. The position collaborates closely with Medical Affairs teams, Compliance, Legal, Finance, and external partners to support scientific exchange and stakeholder engagement at key medical meetings. The role focuses on operational excellence, process consistency, and compliance while supporting the successful execution of congress-related activities.
Role and Responsibilities:
  • Lead operational planning and execution of Medical Affairs congress sponsorship activities for national, regional, and international medical and scientific meetings.
  • Manage Medical Affairs sponsorship applications, agreements, congress organizer documentation, and vendor coordination related to medical congress participation.
  • Coordinate review and execution of Medical Affairs congress-related Statements of Work (SOWs), budgets, purchase orders, and invoices.
  • Partner with Compliance, Legal, and Finance to ensure Medical Affairs congress activities, sponsorships, grants, and external payments meet company policies, fair market value requirements, and applicable regulations.
  • Maintain accurate documentation and tracking systems for Medical Affairs congress sponsorships, medical grants, medical booth activities, scientific exchange programs, and associated expenditures.
  • Serve as the Medical Affairs operational contact for congress organizers, vendors, exhibit partners, meeting planners, and logistics partners involved in medical congress activities.
  • Coordinate congress timelines and deliverables with Medical Affairs, Publications, Medical Communications, Field Medical, and Scientific Affairs stakeholders.
  • Support operational execution of medical booths, scientific exchange activities, medical education programs, advisory boards, investigator meetings, and other Medical Affairs congress programs.
  • Develop and maintain Medical Affairs congress operational calendars, project plans, budgets, and status reports.
  • Track operational metrics, budget utilization, congress deliverables, and compliance documentation for Medical Affairs leadership review.
  • Identify opportunities to improve Medical Affairs congress planning processes, vendor management practices, documentation standards, and operational efficiency.
  • Support audit readiness and compliance requirements related to Medical Affairs congress sponsorships, grants, scientific exchange activities, and related documentation.
  • Monitor medical congress trends, evolving congress regulations, and Medical Affairs operational best practices to support compliant execution.

Experience, Education and Specialized Knowledge and Skills:
  • Bachelor's degree in Life Sciences, Healthcare, Business, or related field.
  • Minimum of 3 years of experience in pharmaceutical, biotech, medical affairs, congress operations, meeting planning, or related operational roles.
  • Demonstrated experience managing medical congress sponsorships, exhibits, scientific meetings, or healthcare professional engagement programs.
  • Strong understanding of healthcare compliance requirements, FMV principles, Sunshine Act reporting, and vendor contracting processes.
  • Experience managing budgets, purchase orders, contracts, and vendor relationships.
  • Strong project management and organizational skills with the ability to manage multiple concurrent congress activities.
  • Excellent communication and stakeholder management skills.
  • Experience in oncology and launch-stage organizations preferred.
  • Familiarity with medical affairs congress planning processes, grants, sponsorships, and exhibit management.
  • Proficiency with project management, budgeting, and congress management tools.

This is the pay for this position
Pay Transparency
$148,000-$174,000 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.
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.

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