Executive Director, Regulatory Affairs – Global Regulatory Leader
Summit TherapeuticsAbout the role
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)
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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.
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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.
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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)
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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 Executive Director of Regulatory Affairs - Global Regulatory Leader, is responsible for developing and implementing global strategies to secure IND/CTA approvals for various studies as well as providing regulatory leadership for planning and execution of subsequent global marketing applications (BLA/MAA) for product(s) in the oncology therapeutic area.
Role and Responsibilities:
- Act independently to lead global regulatory strategies for assigned products/indications through all phases of development to include regulatory approvals/product launches, and post-marketing efforts, with little to no oversight.
- Will represent Regulatory Affairs as relates to development collaborations and/or partnerships, to include leading due diligence as required supporting BD activities
- For new indications assigned, will lead effort on behalf of regulatory cross-functionally with colleagues from clinical, biostatistics, commercial, medical affairs, clinical pharmacology, safety, and others. Expected to provide material (content) input into potential study synopses and corresponding global regulatory briefing documents.
- Continually expands TA knowledge and ensures strategic messaging and content of global regulatory dossiers, to include development of tumor landscape assessment to inform evolving development strategy.
- Advises management and cross-functional team members of the effect of current or proposed relevant laws, regulations, guidelines, and standards, etc.
- Key internal leader and driver of regulatory policy and strategy for assigned products
- Lead regulatory team in the preparation and maintenance of risk assessment and mitigation strategy development for assigned products
- Lead labeling strategy for given product(s)/indication(s), in support of initial license applications through post-marketing
- Demonstrates excellent understanding of drug development and leadership behaviors consistent with the level
- Accountable for ensuring that corporate goals are met with respect to assigned projects
- Based on experience and scientific strengths, expands TA knowledge of TA; provides coaching and mentoring for other regulatory members and extra-departmental colleagues
- Will have direct reports and contributes to the performance management for other RA team members
- May advance the organization's goals by participating and taking leadership roles in professional associations, industry, and trade groups as appropriate
- Follows budget allocations
Experience, Education and Specialized Knowledge and Skills:
- Bachelor's degree in life sciences (ph
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