Associate Director, Clinical Science

Primary Responsibilities

• Leads activities in preparation of protocols, amendments, and other clinical documents such as informed consents, clinical study reports, and investigator brochures
• Conducts data review and activities, including eligibility confirmation and routine review of safety and efficacy parameters
• Works effectively with internal and external stakeholders to ensure efficient execution of the clinical trial programs, including study design, protocol writing, start-up, execution, analysis, and submission to regulatory authorities
• Provides protocol training at kick-off meetings, study team trainings, investigator meetings, and other internal/external meetings as applicable
• Collaborates with data management (DM) and cross-functional study team in electronic Case Report Form (eCRF) development and other DM activities, such as edit check development and database lock processes
• Interacts with clinical investigators during trial setup, conduct, and monitoring
• Led deliverables and presentations for data monitoring and other review committees
• Collaborates on the interpretation, reporting, and preparation of oral and written results with senior clinical personnel

Competencies

• Knowledge of Good Clinical Practices (GCP) and regulatory requirements for the conduct of trials
• Comfortable proactively solving issues
• Strong strategic skills and agility
• Developed understanding of clinical oncology and the drug development process, including regulatory, drug supply, preclinical development, and commercialization
• Strong and effective leadership skills of multi-disciplinary teams within an environment of oncology drug development
• Ability to work independently within a defined strategic context
• Comfortable taking initiatives and smart risks
• Good business judgement and excellent organizational skills

Experience

• Bachelor’s degree in a scientific field or related area; advanced degree preferred
• Minimum of 7 years of experience in drug development Phase I-III within the pharmaceutical or biotechnology industry
• Oncology experience required; hematology-oncology experience highly preferred
• Proven track record of working effectively within a multi-disciplinary team environment of oncology drug development, particularly Phase I-III
• Demonstrated experience in clinical data review, protocol and clinical document development, and data monitoring activities