Senior Director, Regulatory CMC

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.

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 Director, Regulatory Affairs, CMC, is responsible for developing Regulatory Strategies and Submissions for Summit products globally. This role will provide regulatory strategy leadership, for development, commercialization and life cycle management of Summit products.

The Senior Director will work in close collaboration with cross functional teams including Manufacturing, Analytical, Supply Chain and Quality to develop regulatory strategies aligned with company goals. The Senior Director will bring hands on experience leading regulatory CMC programs in biologics and demonstrated leadership skills. This role is both strategic and hands-on and will be responsible for all the regulatory CMC activities.

Role and Responsibilities:

• Develop CMC regulatory strategies for biologics at all stages of development from early Phase through marketing applications and post-approval changes.
• Accountable for providing high level strategic and operational regulatory direction on regulatory CMC issues globally.
• Accountable for leadership in strategic regulatory development plans and risk assessments, critical issue management and advice on Health Authority interactions.
• Responsible for ensuring the appropriate execution of all regulatory CMC strategies.
• Lead CMC content authoring, review, and approval of regulatory submissions, including INDs, IMPDs, BLAs/MAAs, supplements, and responses to health authority questions
• Lead regulatory CMC activities supporting commercial manufacturing, supply continuity, and inspection readiness
• Serve as Senior CMC regulatory lead on interactions with health authorities including leading the planning and preparation for Meetings with Health Authorities
• Assess regulatory risk associated with CMC and manufacturing decisions, and advise senior leadership on mitigation strategies
• Provid…