| The Director, Clinical Research Oncology within the Clinical Development Department is responsible for providing the medical input and medical oversight for early or late stage Oncology clinical development programs. Strategic responsibilities include design and execution of clinical development plans for oncology products from preclinical research, First in Man studies through Phase I/II/III Clinical Trials. |
The incumbent will successfully lead clinical trials Phase II - III, develop and author the necessary documents (e.g. NDA/CTA submissions, study protocols, Investigator Brochures, regulatory briefing books and regulatory response documents, clinical study reports, etc.) and provide expert clinical oncology input and review of the study data as well as lead publication of documents required.
Primary Responsibilities include but are not limited to:
• Directs and implements clinical research plans and programs according to established design principles
• Directs the integration of the Clinical Development Plan (CDP) and the Drug Development Plan
• Leads the development of Clinical Protocols to meet CDP objectives
• Serves as Study Director and drives the execution of the study from protocol concept to final report including interpretation of clinical data
• Serves as the Medical Monitor for a study or clinical program, reviews and monitors study safety data
• Implements strategies to identify, monitor and resolve clinical/program trial issues
• Serves as the clinical/medical team expert to provide direction to all project team functions, organizes Advisory Board meetings (e.g., agenda setting), and identifies and liaises with KOL regarding program strategy and scientific advice
• Interprets study data and develops integrated summaries for safety and efficacy. Contributes clinical expertise and content to regulatory documents (e.g. briefing books, NDAs, etc.)
• May represent Clinical team in discussions with Health Authorities
• Sets key deadlines and project milestones within function
• Makes appropriate budgetary allocations to targeted opportunities
• Reviews 3rd party (contractors, consultants and vendors) work product an deliverables to approve payment of invoices and resolves issues.
• Leads by example to encourage others to prioritize personal and professional development.
• Complies with all applicable laws/regulations of each country in which we do business
• Demonstrates high ethical behavior at all times, whether dealing with colleagues, vendors, patients, or physicians