Join The Beam Team

Director/Senior Director of Clinical Operations

Directions to apply

Submit your resume to careers@beamtx.com

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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.

Primary Responsibilities:

  • 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.

Qualifications:

  • 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.