Director Clinical Operations, Gene Therapy 1068635
Job Scope & Purpose:
Our long-term client, focused in gene therapy is seeking an experienced and motivated Director of Clinical Project Management to be responsible for the planning, implementation, execution, and management of one or more clinical programs/studies. This individual will provide leadership of cross-functional study teams to ensure studies are conducted on time, within budget and with high quality. Additionally, the individual will drive vendor oversight activities to ensure the appropriate transfer, accountability, and execution of delegated tasks.
Primary Job Responsibilities:
- Direct and manage cross-functional teams in the planning and execution of clinical programs/studies from study start-up through closeout.
- Represent Clinical Operations on the Product Development Team (PDT); contribute to the product development strategy, provide operational updates and risk analysis, ensure study teams action on PDT decisions.
- Collaborate with Program Management and Finance to ensure program timelines and budget forecasts are current and accurate.
- Conduct ongoing risk assessment and implement contingency plans, as appropriate.
- Lead and oversee the selection of third-party vendors, including CROs.
- Work with internal and external stakeholders to optimize patient recruitment and enrollment strategies.
- Identify and implement opportunities to optimize/enhance processes and or systems to accelerate programs.
- Participate in the authoring, review, and finalization of clinical documents such as protocols, informed consent forms, clinical study reports (CSRs), pharmacy and surgical manuals, regulatory submissions and other documents as required.
- Develop and implement plans to ensure inspection readiness and oversee activities in support of GCP audits and regulatory inspections.
- Participate in the development of SOPs and clinical operational systems.
- Manage and mentor direct reports.
Primary Job Requirements:
- Bachelor's degree in a relevant field and ten (10) years of relevant clinical research experience at a Pharmaceutical or Biotech company or CRO, or
- Master's degree in a relevant field and eight (8) years of relevant clinical research experience at a Pharmaceutical or Biotech company or CRO.
- At least five (5) years of relevant experience managing/leading clinical studies, including Phase 2 and Phase 3.
- At least two (2) years of managerial/supervisory experience.
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