Director of Clinical Operations
Northern, NJ (Hybrid)
Compensation: $200,000-240,000 + Bonus + Equity
Company Summary: We have partnered with a rapidly growing ADC oncology company with over 400 million dollars in funding looking to expand its Clinical Operations Team. This company is working on over 8 clinical studies, 2 of which are in a phase 3 clinical trial. Leadership team has a track record of successful approval in the oncology space. Their previous success indicates approval is right around the corner.
Primary Responsibilities:
- Lead the clinical operations team to drive and execute strategy, ensuring alignment with corporate goals and objectives. Focus on operational excellence, cross-functional collaboration, and innovation.
- Design, implement, and conduct Phase 1-3 clinical trials within established budgets and time lines, in compliance with Good Clinical Practice (GCP) and relevant regulations.
- Author or review study documents, including study protocols, informed consent documents, Investigator's Brochures, pharmacy manuals, and monitoring plans.
- Take responsibility for all clinical trial time lines, budgets, and deliverable.
- Develop and maintain strong collaborative relationships with study investigators, clinical sites, external business partners, and service providers.
- Identify and communicate potential risks associated with strategic scenarios.
- Oversee the selection, management, and supervision of Contract Research Organizations (CROs), vendors, and study sites.
- Facilitate collaboration with international partners on shared studies.
Qualifications:
- 8+ years clinical operations experience.
- Experience in oncology
- Global experience
