Director, Cancer Clinical Research Regulatory Affairs

DESIRED QUALIFICATIONS: 

• Advanced degree in biological science, health science or health related field
• Demonstrated leadership experience in regulatory affairs (oncology clinical trials preferred)
• Demonstrated knowledge and understanding of regulations and guidelines governing clinical research
• Clinical trial activation experience

EDUCATION & EXPERIENCE (REQUIRED):  
Bachelor’s degree and ten years of relevant experience, or combination of education and relevant experience. 

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

• Demonstrated leadership skills and ability to influence and motivate constituencies which could span multiple organizational boundaries.
• Demonstrated excellent planning, organizational and analytical skills. 
• Demonstrated ability to make sound business decisions using good business judgment and innovative and creative problem-solving.
• Demonstrated ability to manage financial, organizational and staff resources.
• Excellent interpersonal and communications skills with the ability to cultivate professional and business partnerships.
• Relevant subject matter expertise.
• Strong project planning and management skills.
• Experience in or knowledge of business process improvement methodology.
• Ability to act independently and as part of a team.

CERTIFICATIONS & LICENSES:    

Clinical Research Certification (SoCRA, ACRP or equivalent) preferred

PHYSICAL REQUIREMENTS*:

• Constantly perform desk-based computer tasks. 
• Frequently stand/walk, sitting, grasp lightly/fine manipulation.
• Occasionally use a telephone. 
• Rarely lift/carry/push/pull objects that weigh 11-20 pounds.

*- Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.

WORK STANDARDS:

• Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
• Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors bases on training and lessons learned.
• Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University’s Administrative Guide, http://adminguide.stanford.edu.

The expected pay range for this position is $140,000 to $188,000 per annum. Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs.

 As an organization that receives federal funding, Stanford University has a COVID-19 vaccination requirement that will apply to all university employees, including those working remotely in the United States and applicable subcontractors. To learn more about COVID policies and guidelines for Stanford University Staff, please visit https://cardinalatwork.stanford.edu/working-stanford/covid-19/interim-policies/covid-19-surveillance-testing-policy