Summit Therapeutics
Director, Clinical Scientist
Remote (US) · Director
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About the role
- The Director, Clinical Scientist will strive to drive study enrollment and build and maintain collaborative relationships with investigators and clinical site staff, CROs, and Summit colleagues.
- Bladder Cancer Harmoni-GU1:
- As a leader within the clinical organization, this individual will be partnering with clinical operations, translational, and other matrix team members to design and refine clinical plans, authoring key clinical/regulatory documents, and ensuring exceptional delivery and interpretation of clinical data.
Responsibilities
- Leads/Contributes to study design and amendments in collaboration with internal and external scientific stakeholders
- Collaborates with MD, regulatory and other internal partners/stakeholders with authoring and submission of protocols, protocol amendments, regulatory filings, and other regulatory documentation
- Develops and provides input for clinical presentation slides and other materials for internal/external meetings and/or ongoing communications (e.g., investigator meetings, pre-study site selection visits, study coordinator or clinical research administrator training, study newsletters, communications to study sites, etc.)
- Partners with clinical operations and CRO in developing and maintaining study start up documents/resources (e.g., ICF, Lab Manual, EDC, Safety monitoring Plan, etc.)
- Writes and/or reviews abstracts, posters, content for scientific meetings, conferences, other events and presentations, and other publicly distributed materials and coordinates further reviews with internal partners and stakeholders
- The Director, Clinical Scientist is responsible for leading/contributing to study design and execution of clinical studies in hematology/oncology.
- Leads/Contributes to the development and implementation of communications strategies to support existing and concluded studies.
Requirements
- Writes clinical science sections of meeting packages and assists in the development and review of other clinical documentation required for regulatory submissions and other regulatory processes
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
- MS (or equivalent) required; PhD, PharmD, or MD preferred
- Minimum of 5+ years overall related e
Benefits
- Collaborates with clinical operations, data management and CRO to develop and implement the overall data quality plan and leads internal medical data review and safety trend analysis on one or more studies/programs
- Point-of-contact for clinical inquiries from CRO medical monitor and other stakeholders
- Includes KOL interactions, advisory boards, major medical meetings, congresses and other events, publications and other materials
- Experience, Education and Specialized Knowledge and
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.