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Director, Clinical Sciences
2 months ago
The Director, Clinical Science is responsible for leading/contributing to study design and execution of clinical studies in hematology/oncology. As a leader within the clinical organization, this individual will be part of the global clinical development team, 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. The Director, Clinical Science will strive to drive study enrollment, and build and maintain collaborative relationships with investigators and clinical site staff, CROs, and Summit colleagues. The Director, Clinical Science will foster a proactive and thoughtful approach to clinical study execution where obstacles are anticipated and effectively mitigated/resolved, and will report to the EU Medical lead.
Role and Responsibilities:
Leads/Contributes to study design and amendments in collaboration with internal and external scientific stakeholders
Collaborates with Medical Directors, regulatory and other internal partners/stakeholders with authoring and submission of protocols, protocol amendments, regulatory filings, and other regulatory documentation
Collaborates with clinical operations, data management and CRO to develop and implement the overall data quality plan and leads internal medical data cleaning review and safety trend analysis on one or more studies/programs
Point-of-contact for clinical inquiries from Summit and CRO medical monitor and other stakeholders
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 (eg, ICF, Lab Manual, EDC, Safety monitoring Plan, etc.)
Participates in safety meetings and tracks, analyzes, and reviews documentation for any potential safety events
Leads/Contributes to the development and implementation of communications strategies to support existing and concluded studies. Includes KOL interactions, advisory boards, major medical meetings, congresses and other events, publications and other materials
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
Coordinates submissions to scientific meetings and/or other appropriate venues or groups
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
Experience, Education and Specialized Knowledge and Skills:
MS (or equivalent) required,
PhD, PharmD, or MD preferred
8+ years overall related experience with PhD or like degree; Minimum of 2 years’ experience in conducting / supporting oncology/hematology clinical studies
Excellent written and verbal communication skills
Expertise in interpreting immunology/immuno-oncology translational data in addition to clinical data
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