JOB SUMMARY
The Senior Director/Vice President of Clinical Operations will be responsible for the planning, implementation, execution and management of clinical studies by overseeing day-to-day operations and directly managing and working with outside Clinical Research Organizations and academic institutions. Additionally, will work closely with cross-functional teams, senior leadership, and external stakeholders to meet clinical milestones while maintaining high-quality standards, timelines, and budgets. The candidate must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient. Ability to analyze complex issues to develop relevant and realistic plans and recommendations.
RESPONSIBILITIES:
- Develop and execute clinical operations strategies aligned with the company’s overall goals and objectives.
- Plan and communicate with cross-functional teams to ensure proper initiation, execution, and conduct of clinical trials and generation of high-quality clinical data.
- Serve as a primary point of contact and resource for clinical operations activities for CROs, vendor personnel, investigator site personnel, and other team members at Orbital.
- Collaborate with medical, regulatory, data management, biostatistics, and other functional teams to align clinical operations with overall program goals.
- Interact and work closely with the clinical consultant to ensure proper execution of the clinical activities.
- Provide oversight and management of CROs, consultants, vendors, and clinical sites.
- Oversee and monitor the management of clinical studies ensuring they are conducted in compliance with the agreed study plans and all applicable regulations and requirements.
- Monitor progress of clinical activity and report on the progress of assigned clinical trials including budget, timelines, and clinical data collection.
- Prepare potential investigator site lists and assist with their evaluation for inclusion in the study.
- Review and approve study-related plans generated by CROs and vendors, and ensure the documentation is in accordance with GCP regulatory requirements and consistent with the protocol for assigned studies.
- Participate in the authoring, review and finalization of clinical study-related documents such as protocols, protocol amendments, clinical study reports (CSRs), regulatory submissions and other publications as required.
- Coordinate the delivery of clinical trial supplies in collaboration with CRO and other team members.
- Request and critically evaluate proposals and change orders from CROs, vendors and investigator sites (as applicable).
- Manages escalation of study related issues and communicates as appropriate.
- Anticipate potential study issues and to prepare contingency plans with minimal oversight.
QUALIFICATIONS:
- Requires a BA/BS preferably in nursing, biology, biochemistry, or related areas (advanced degrees desirable) with at least 15 years of experience in clinical research operations.
- Experience in phase I to phase III clinical studies. Global experience a plus.
- Experience in immunology, hematology, oncology, or rare disease indications is a plus.
- Understands and ensures adherence to SOPs, ICH/GCP, and FDA and other health authorities’ regulations, with strong understanding of inspection readiness.
- Demonstrated knowledge and experience in the regulatory aspects of pharmaceutical development, including protocol implementation, data collection and reporting, and understands preparation of regulatory submissions.
- Demonstrated experience in study management/monitoring, as well as working and negotiating with CROs.
- Demonstrated project management expertise, including the leadership and development of cross functional teams.
- Demonstrated ability to work independently with exceptional organization and attention to detail.