Director / Sr. Director Clinical Operations

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.