Summit Therapeutics
Senior Director, Regulatory CMC
Remote (US) · Director
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About the role
- This role will provide regulatory strategy leadership, for development, commercialization and life cycle management of Summit products.
- This role is both strategic and hands-on and will be responsible for all the regulatory CMC activities.
Responsibilities
- Develop CMC regulatory strategies for biologics at all stages of development from early Phase through marketing applications and post-approval changes.
- Lead regulatory CMC activities supporting commercial manufacturing, supply continuity, and inspection readiness
- Manage regulatory CMC aspects of relationships with collaborators and external manufacturing partners
Nice to have
- Summit's core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people.
- 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)
- 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.
- 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)
- Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.
Skills
- The Senior Director will bring hands on experience leading regulatory CMC programs in biologics and demonstrated leadership skills.
Benefits
- Accountable for leadership in strategic regulatory development plans and risk assessments, critical issue management and advice on Health Authority interactions.
- Lead CMC content authoring, review, and approval of regulatory submissions, including INDs, IMPDs, BLAs/MAAs, supplements, and responses to health authority questions
- Serve as Senior CMC regulatory lead on interactions with health authorities including leading the planning and preparation for Meetings with Health Authorities
Company info
- Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence.
This listing is sourced directly from Summit Therapeutics's careers page and normalized into a canonical job model.