Position: Director/Associate Director, Clinical Research Strategy & Design – Oncology Job 2480
Location: United States - Remote
Compensation: Title and Compensation are Based Upon Experience
Summary: The Director/Associate Director of Clinical Research Strategy & Design will work closely with team members of different functional groups to ensure flawless execution of study start-up activities, study oversight, and reporting of the assigned clinical studies. Phase I-III strategy and design experience preferred. Oncology and large molecule experience highly desired. Position will be filled at level commensurate with experience.
Essential Functions:
Participate in and provide input to the development of the clinical strategy. Assist in the clinical site and service vendor selection.
Contribute to the study design and the development of study protocol, informed consent forms, eCRFs, study manuals, clinical study reports, and regulatory submission documents.
Work closely with the clinical research physician and other functional groups to address protocol questions from Health Authorities and Ethics Committees in a consistent fashion.
Participate in investigator meetings, investigator engagement, and site training; Works closely with Clinical Operations to track study recruitment and implement action plans to address early sign of slow enrollment.
Work closely with the clinical research physician and other functional groups to ensure comprehensive medical monitoring, thorough and timely responses to address site issues and eligibility questions, and detailed, real-time review of serious adverse events
Work closely with clinical research physician and Data Manager to support medical review and data query resolution.
Work with Clinical Operations to provide oversight of CRO vendors’ performance as it relates to study start-up and study conduct.
Qualifications:
An advanced degree in a scientific discipline (i.e., M.S, Ph.D., Pharm.D. or equivalent) is required.
A minimum of 3-5 years of working experience in a related clinical research position within the pharmaceutical industry is preferred.
Knowledge of Good Clinical Practices and regulatory requirements for the conduct of high-quality oncology clinical trials is highly desirable.
Significant knowledge of cancer drug development is highly preferred. Ability to work independently, prioritize and work in a matrix team environment is essential.
Experience in clinical protocol development, medical review, oversight of study conduct, running trials, data quality and safety are strongly preferred.
Successful work experience in a matrix team environment with cross functional teams is required.