The Director is accountable for the oversight and execution of Clinical Operations for a full development program within Immuno-Oncology/Rare Disease, and their direct reports on the Immuno-Oncology/Rare Disease Operations team. They are well versed in knowledge of operational methodologies, clinical research, ICH/GCP Guidelines, program management, communication to upper management and delegation to/oversight of Clinical Trial Managers. They are responsible for the development of the clinical timelines, and are the co-author of the individual study timelines/deliverables/milestones.
Duties and Responsibilities:
- Have the skillset and experience to manage (or oversee the execution of – and assisting when necessary) all related study start up, maintenance and close out activities.
- Create and maintain Operations Budget forecast and execution, contribute to the Clinical Development Plan, with program oversight of all aspects of the clinical operations budgets of all studies within their program.
- Responsible for the clinical operations program related timelines and study timelines/deliverables/milestones.
- Have experience with and the ability to prioritize day to day issues and overarching goals with a keen eye to (understanding of and compliance with) ICH/GCP Guidelines, escalating to Upper Management as appropriate.
- Drive RFP generation, vendor selection, review of SOWs and Change Orders, as well as acting as a point of escalation for vendors within their clinical program.
- Contribute to and assist in maintaining a quality-focused clinical infrastructure by assisting in development, revision and/or implementation of SOPs consistent with the organization’s day to day execution of trials such that operational processes, systems and standards are consistent with GXP and are adopted, implemented and documented consistently across trials and programs.
- Develop and maintain strong relationships with cross-functional key stake holders within Beam.
- Strong collaboration with other departments, towards common and related goals.
- Maintain direct reports, regular meetings and oversight as well as complete all yearly review activities; Review and sign off on direct report’s documents.
- Train and mentor direct reports and junior staff on Clinical Operations processes and the related execution of GCP and ICH guidelines such that compliance is the top priority, followed closely by excellent execution of all responsibilities.
- Lead process improvement initiatives, helping to maintain best practices and lessons learned across programs.
- Advanced degree preferred, or at least a Bachelor’s Degree in a science based field.
- At least ten years’ experience in the biotech and/or pharmaceutical industries, with at least nine years in clinical operations.
- Global clinical trial/Program Management and Phase I experience are both necessary, as is extensive experience in Immuno-Oncology/Rare Disease development.
- Thorough understanding of GCP/ICH Guidelines, global regulatory requirements and strategic implications for downstream clinical development.
- Extensive vendor oversight and management experience, including negotiations and contract execution.
- Excellent interpersonal and communications skills (verbal and written), including clinical authoring experience of protocols, ICF, IBs, etc., as well as superior problem solving skills.
- Demonstration of strong management abilities and mentoring skills, with preferably six or more years prior experience managing, mentoring and training Clinical Operations staff.
- Ability and willingness to travel up to 20% (domestic and international).