Manager, Global Medical Affairs Operations Contract

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. Summits 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.

Summits team is inspired to touch and help change lives through Summits 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 Chinas 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. Summits 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.

Summits team is inspired to touch and help change lives through Summits 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 Chinas 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:

• Bachelors 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 Summits Talent Acquisition team atto obtain prior written authorization before referring any candidates to Summit.

Summit Therapeutics 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.