[Hiring] Director, Clinical Scientist @Summit Therapeutics

Role Description

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
• Author key clinical/regulatory documents
• Ensure exceptional delivery and interpretation of clinical data
• Drive study enrollment
• Build and maintain collaborative relationships with investigators, 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.

Role and 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 (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.)
• 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
• All other duties as assigned

Qualifications

• MS (or equivalent) required; PhD, PharmD, or MD preferred
• Minimum of 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

Requirements

• Pay Transparency: $192,000 — $239,000 USD
• Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location.
• The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.

Company Description

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. Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.