Director, Therapeutic Products Strategy

U.S.-Food-and-Drug-Administratio; Hillandale (MD); On-site; USD 150,000 - 190,000; Full time

Job summary

The U.S. Food and Drug Administration seeks a Super Office Director in the Office of Therapeutic Products in Maryland (Hillandale). This senior leadership role uses Title 21 Pay Table 4, Band H to guide scientific, regulatory, and policy decisions affecting public health.

Responsibilities include directing multidisciplinary staff, providing strategic counsel to senior leadership, and ensuring regulatory compliance; collaboration across teams; and ethical and fiduciary accountability.

Qualifications

• Experience in scientific and technical leadership, direction, and supervision to multidisciplinary scientific, engineering and medical science staff.
• Proven ability to provide strategic scientific and technical counsel to senior leadership on complex, novel, controversial, and precedent-setting regulatory and policy issues, and to evaluate and apply regulatory requirements in support of public health decision-making.
• Demonstrated expertise in cellular and gene therapies, therapeutic vaccines, plasma-derived and coagulation products, and associated medical devices, including comprehensive knowledge of FDA regulatory authorities, policies, and guidance.
• Collaborates with other scientific, technical, and regulatory staff to develop and implement policy initiatives related to cellular, tissue gene therapy (including viral and non-viral vectors), therapeutic vaccines, and plasma-derived and coagulation products as well as associated medical devices.

Responsibilities

• The incumbent is delegated full authority to achieve group goals and objectives through the effective management of available resources.
• Leads in a proactive, customer-responsive manner consistent with Agency vision and values, effectively communicating program issues to external audiences.
• Ensures financial and managerial accountability by acting with prudence when executing fiduciary responsibilities.
• Demonstrates high integrity and adheres to the highest ethical standards of public service.
• Uses effective business practices including balanced measures of results, values, and invests in each employee; emphasizes empowerment and two-way communication.

Job description

The U.S. Food and Drug Administration seeks a Super Office Director in the Office of Therapeutic Products in Maryland (Hillandale). This senior leadership role uses Title 21 Pay Table 4, Band H to guide scientific, regulatory, and policy decisions affecting public health.

Responsibilities include directing multidisciplinary staff, providing strategic counsel to senior leadership, and ensuring regulatory compliance; collaboration across teams; and ethical and fiduciary accountability.