Director / Sr. Director Clinical Operations
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Director/Sr. Director Clinical Operations
I-ACT for Children
Sr. Director Clinical and Scientific Development
Full time
Washington, DC
Education Requirements
- MS, PhD, or other advanced degree
Work Experience
- 10-15 years of experience in clinical research, including clinical operations, regulatory affairs, portfolio management, strategic planning. Experience in pediatrics is preferred.
Job Duties and Responsibilities
- Strategy, Planning and Execution
Strategy
- Identify practical ways that the organization can add value in selected therapeutic areas, education and training, generalizable solutions and collaboration with other research organizations
- Assist in the evaluation of innovative study designs, use of quantitative/qualitative science and other methodologies that improve quality, timeliness and speed in new product development
- Assist in development of annual objectives and related annual budget; monitor progress to plan
- Assist in the identification and engagement of physician/scientist consultants
- Recommend resource planning/allocation to support priority work
- Provide visibility to project status, issues, risks and costs and deploy resources accordingly
Stakeholder Engagement
- Assist in the preparation and follow up of meetings with members and with regulatory authorities
- Conduct project-specific preparatory research, gather and analyze data and insights to stay abreast of scientific, clinical and regulatory dynamics in pediatric drug and device development
- Work closely with other children’s research networks such as IMI2, C4C, COG, MICRYN, and federal agencies such as FDA and NIH
Portfolio Management
- Provide transparency and insight into upcoming projects by assessing needs in therapeutic areas and matching those needs with the organization’s capabilities and resources
- Prepare rolling view of potential projects (e.g. strategy & planning, leadership opportunities and educational sessions)
Individual Projects
- Actively support the Scientific Review Committee (SRC), providing input into the review and assessment of new and ongoing projects from clinical, scientific, ethical and operational perspectives
- Work with sponsors to ensure that the needed clinical, scientific and regulatory background is provided to enable SRC review of projects
- Oversee the launch and management of projects
- Assist in staffing the projects and ensuring that deliverables and timelines are met
- Maintain records of assessment decisions and follow up to ensure communications with sponsors occur on a timely basis
- Provide medical writing support as needed
Supervisory Responsibility:
This position will supervise direct reports as well as contract personnel and volunteers
Travel:
Domestic and international travel: <20%
Salary & Benefits:
Commensurate with experience and aligned with US benchmarked ranges for a research-based non-profit of this size and complexity.