Director, Clinical Science

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:

• Support the design and implementation of development strategies for programs entering the clinic, providing strategic clinical science input for all assigned programs
• Collaborate cross functionally with Clinical Operations team members to support the design and execution of clinical trials. This may include assistance in the development of essential clinical trial documents such as protocols, ICF documents/amendments, CRF’s, CSR’s, and Investigator Brochures
• Aid in the development of the Data Review Plan and Data Review Strategy, ensuring that protocol-level deviations, eligibility criteria, study assessments & other aspects of the protocol are implemented consistently across the study
• Perform clinical data review and identify clinical data insights through ongoing patient level review and trends analysis, working cross-functionally to monitor clinical data
• Promote quality review of data with an emphasis on subject safety and eligibility, data integrity, trend identification, analysis and remediation, and identification of AEs/SAEs for medical review
• Support ad-hoc Regulatory activities such as contributing by authoring/reviewing clinical portions of Regulatory Documents and/or posters, abstracts and manuscripts, and the preparation and conduct of meetings with regulatory agencies and/or external drug development consortiums
• Develop and deliver upon clinical presentation slides and other materials for internal and external meetings
• Maintain scientific and clinical knowledge in the specific therapeutic and disease areas of assignment
• Other duties as required

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES

• Advanced degree in Life Sciences preferred
• Minimum 8 years of industry experience, 5+ years of which dedicated to the conduct of clinical trials as a Clinical Scientist
• Knowledge of Oncology drug development and clinical trial processes, study design, statistics and clinical operations within a similar biotech and/or pharmaceutical environment
• Skills to support program-specific data review and trend analysis
• Knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees
• Knowledge of GCP and regulatory requirements
• Ability to critically evaluate data, literature and presentations
• Ability to lead and work with cross-functional teams
• Strong project management skills