The Director/Senior Director 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. 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. Excellent written and verbal communication skills, strong problem-solving ability, and attention to detail and quality are critical to success.
- 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 Beam.
- 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 assists with their evaluation for inclusion in the study.
- Review and approve study-related plans generated by CROs and vendors, and ensures 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.
- Prepare and deliver program/study updates.
- 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.
- Ensure assigned studies adhere to all applicable regulations and requirements.
- Requires a BA/BS preferably in nursing, biology, biochemistry, or related areas (advanced degrees desirable) with at least 10 years of experience in clinical research operations.
- Experience in phase I-III clinical studies. Global experience a plus. Experience in hematology, oncology, or rare disease indications 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.