Director, Clinical Scientist

Summit Therapeutics Plc • Menlo Park, CA

81d • $186,000 - $233,000

About The Position

The 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, authoring key clinical/regulatory documents, and ensuring exceptional delivery and interpretation of clinical data. 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. The Director, Clinical Scientist will foster a proactive and thoughtful approach to clinical study execution where obstacles are anticipated and effectively mitigated/resolved.

Requirements

• MS (or equivalent) required
• PhD, PharmD, or MD preferred
• 5+ 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

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
• 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
• 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
• Writes and/or reviews abstracts, posters, content for scientific meetings, conferences, other events and presentations
• 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
• All other duties as assigned

Benefits

• The pay range for this role is $186,000-$233,000 annually
• Total compensation package may include bonus, stock, benefits and/or other applicable variable compensation

What This Job Offers

• Career Level: Senior
• Industry: Ambulatory Health Care Services
• Education Level: Master's degree