Director, Clinical Science

About the role

The Director Clinical Scientist is an important and visible member of the Clinical Development team, working collaboratively with the Clinical operations lead and medical director. The role involves scientific oversight, data integrity, and quality assurance of clinical trials.

Responsibilities

• Scientific oversight and data integrity of clinical trials
• Supporting strategic development and providing final recommendations to senior management
• Independent leadership of clinical execution of one or more studies
• Leading the development of protocols and associated amendments
• Supporting governance review and approval processes
• Leading the development and review of key documents such as ICD, Investigator Brochure, Investigators Letters, and safety documents
• Providing scientific/medical guidance to the study team, including the CRO team
• Reviewing safety data, SAE reports, and authoring/reviewing safety or regulatory documents
• Leading the examination and interpretation of clinical data at the study and program level
• Leading the compilation and analysis of data for and from the dose critical issue committee/safety review committee
• Representing the project internally and externally as a medical scientific expert
• Collaborating with research scientists and translational scientists to provide clinical input in developing data for pre-clinical compounds
• Leading the development and review of content and quality of publications
• Leading the examination and interpretation of clinical data at the study and program level
• Authoring or reviewing the Clinical Study Report
• Attending Site Initiation Visits to present the study design and key aspects of the protocol
• Leading the compilation and analysis of data for and from the dose critical issue committee/safety review committee
• Leading the examination and interpretation of clinical data at the study and program level
• Authoring or reviewing the Clinical Study Report
• Attending (in person or by teleconference) Safety Review Team meetings
• Leading the examination and interpretation of clinical data at the study and program level
• Authoring or reviewing the Clinical Study Report
• Leading the examination and interpretation of clinical data at the study and program level
• Authoring or reviewing the Clinical Study Report

Requirements

• Ph.D., PharmD, or a Masters degree in a relevant Clinical or Biomedical field
• 8+ years of clinical drug development or medical research experience within a pharmaceutical/biotech or academic environment
• Oncology or immunology experience
• Advanced understanding of clinical practice across tumor types and how clinical practice is evolving with the introduction of new therapies
• Understanding of cancer cell biology
• Experience leading delivery and influencing at senior leadership levels both internally and externally
• Strong collaborative communications skills including the ability to engage with a diverse internal and external client base and lead through conflict
• Proven ability in problem solving and issues management that is solution focused
• Experience in collaborating externally in terms of clear requirements for collaborative contracts, influencing delivery and scientific engagement
• Effective communication, presentation, and organizational skills to ensure coordinated and timely delivery of projects
• Demonstrated scientific writing skills
• Embraces Artificial Intelligence and other evolving technologies and adopts best practices aimed at improving efficiency and quality of clinical practice
• Proven team leadership experience in a clinical setting (2-3 years)
• Ability to work proactively and independently, organizational skills, prioritizes self and others
• Ability to support and mentor junior team members