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:

Reporting to the Chief Business & Strategy Officer, the Head of Project Management & Program Management will lead the project management office (PMO) responsible for cross-functional strategic and operational execution of development and ultimate regulatory approval and commercialization of ivonescimab. They will be responsible for driving cross-functional alignment, ensuring delivery of clinical development plans from Phase I through Phase III, and supporting regulatory filings including BLA, MAA, and other global submissions. The Head is accountable for establishing and maintaining an integrated project plan to cover all aspects of the ivonescimab development program(s), including clinical development, regulatory, biometrics, clinical operations, medical affairs, CMC / manufacturing, and commercial.

This leader will shape and oversee the Project Management and Program Management function, building best-in-class project & program management practices and strategic approaches in securing appropriate resources to drive results. They will lead and mentor a team of program and project management professionals and foster strong partnerships across internal teams and external collaborators, including co-development & licensing partners, CROs, and regulatory bodies to ensure program success and maximize portfolio value.

Role and Responsibilities:

• Lead a high-performing Project Management Office that supports strategic planning and execution across all development programs.
• Oversee & define the integrated program plan covering Phase I-III trials and regulatory filings
• Lead cross-functional teams including Clinical, Regulatory, Medical Affairs, CMC, Operations, and Commercial to align on strategy, resolve issues, and drive execution.
• Oversee planning and execution of multiple clinical trials, ensuring readiness for regulatory filings and inspection preparedness.
• Facilitate decision-making processes, including risk mitigation strategies, plan amendments, and scenario planning.
• Present updates, risks, and strategic recommendations to the Executive Leadership Team and other senior stakeholders regarding ivonescimab.
• Mentor and develop project managers and program leads, fostering a culture of accountability, innovation, and continuous improvement.
• Driving strategic alignment for development, research, manufacturing, regulatory, medical affairs, market access, pricing and commercialization plans
• All other duties as assigned

Experience, Education and Specialized Knowledge and Skills:

• Advanced Degree (Ph.D., M.D., Pharm.D., MBA, or applicable master’s degree) with at least 15+ years of pharmaceutical / biotech industry experience, including leadership experience in program management or similar function, is required.
• Proven leadership in project management and program management across Phase I-III clinical trials.
• Experience in cross-functional team leadership, including strategy development and driving tactical delivery of programs.
• Strong experience in drug development and late-stage registration required, oncology experience strongly preferred.
• Deep understanding of regulatory pathways and commercialization strategies.
• Exceptional communication, negotiation, and stakeholder management skills.

The pay range for this role is $300,000-$350,000 annually. 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 human resources department to obtain prior written authorization before referring any candidates to Summit.