Director, Clinical Scientist

Overview

About Summit 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 believes in building a team of world class professionals who are passionate about this mission, and its people drive this mission to reality. Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and a commitment to people.

Our employees are the heart and soul of our culture, and invaluable in shaping our journey toward excellence.

Director, Clinical Scientist is responsible for leading/contributing to study design and execution of clinical studies in hematology/oncology. This role partners with clinical operations, translational, and other matrix team members to design and refine clinical plans, author key clinical/regulatory documents, and ensure delivery and interpretation of clinical data. The Director will drive study enrollment and build and maintain collaborative relationships with investigators, clinical site staff, CROs, and Summit colleagues.

The role fosters a proactive approach to clinical study execution where obstacles are anticipated and mitigated.

• Leads/Contributes to study design and amendments in collaboration with internal and external scientific stakeholders
• Collaborates with MD, regulatory and other internal partners to author and submit protocols, protocol amendments, regulatory filings, and other regulatory documentation
• Coordinates with clinical operations, data management and CRO to develop and implement the data quality plan and leads internal medical data review and safety trend analysis on one or more studies/programs
• Acts as point-of-contact for clinical inquiries from CRO medical monitor and other stakeholders
• Develops input for clinical presentation slides and other materials for internal/external meetings and communications (e.g., investigator meetings, site visits, training, newsletters, site communications)
• Assists in developing and maintaining study startup documents/resources (e.g., ICF, Lab Manual, EDC, Safety Monitoring Plan)
• Participates in safety meetings and tracks, analyzes, and reviews documentation for potential safety events
• Leads/contributes to communications strategies to support studies, including KOL interactions, advisory boards, meetings, congresses, publications, and materials
• Writes/reviews abstracts, posters, and content for scientific meetings and coordinates reviews with internal partners
• Coordinates submissions to scientific meetings and other venues
• Writes clinical science sections of meeting packages and assists in regulatory submissions and documentation
• All other duties as assigned

• MS (or equivalent) required;
  PhD, Pharm
  
  D, or MD preferred
• Minimum of 5+ years of related experience with PhD or equivalent; minimum of 2+ years in oncology/hematology clinical studies
• Excellent written and verbal communication skills
• Expertise in interpreting immunology/immuno-oncology translational data in addition to clinical data

The pay range for this role is $200,000-$250,000 annually. Actual compensation is based on factors including skill set, depth of experience, certifications, and location. The total compensation package may include bonus, stock, benefits, and/or other variable compensation. Summit does not accept referrals from employment businesses and/or employment agencies; all agencies must contact Summit’s Talent Acquisition team at  for prior written authorization before referring candidates.

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