Sr. Director, Clinical & Regulatory Strategy

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Sr. Director, Clinical & Regulatory Strategy

SVP Clinical & Regulatory Strategy


Rockville, MD

Education Requirements

  • MS, PhD, or other advanced degree


Work Experience

  • 15+ years of experience in clinical research, including clinical development, regulatory affairs, portfolio management, strategic planning, healthcare administration and/or other related disciplines. Experience in pediatrics is preferred.


Job Duties and Responsibilities

  • Strategy, Planning and Execution


  • Support the SVP Clinical & Regulatory Strategy in maintaining, updating and executing the strategic plan
  • 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



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.