Senior Director, Clinical Scientist

Senior Director, Clinical Scientist

Overview Of Role The Senior Director, Clinical Scientist 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 partnering with clinical operations, translational, and other matrix team members to design and refine clinical plans, author key clinical/regulatory documents, and ensuring exceptional delivery and interpretation of clinical data.

The Director, Clinical Scientist will strive to drive study enrollment, build and maintain collaborative relationships with investigators and clinical site staff, CROs, and Summit colleagues. The Director will foster a proactive and thoughtful approach to clinical study execution where obstacles are anticipated and effectively mitigated/resolved.

• Leads/Contributes to study design and amendments in collaboration with internal and external scientific stakeholders.
• Collaborates with MD, regulatory and other internal partners/stakeholders for 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 review and safety trend analysis on one or more studies/programs.
• Point-of-contact for clinical inquiries from 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.
• Partners with clinical operations and CRO in developing and maintaining study start-up documents/resources (e.g., ICF, Lab Manual, EDC, Safety monitoring Plan).
• Participates in safety meetings and tracks, analyzes, and reviews documentation for any potential safety events.
• Leads/Contributes to development and implementation of communications strategies to support existing and concluded studies, including 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 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.
• All other duties as assigned.

• MS (or equivalent) required.
• PhD, Pharm
  
  D, or MD preferred.
• 5+ years overall related experience with PhD or similar 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.

London, England, United Kingdom