Senior Regulatory Specialist

Senior Regulatory Specialist – Cancer Cell Therapy (Hybrid)

The Center for Cancer Cell Therapy (CCT) at Stanford University is seeking a Senior Regulatory Specialist to be responsible for the administration and regulatory compliance of clinical research within the university, and representing the university with external regulatory agencies, both domestic and international. This position will support high-impact early phase clinical trials in the CCT group in a variety of cancer indications in both adult and pediatric patient populations. 

The Senior Regulatory Specialist will work within in multidisciplinary teams of highly-skilled physicians, research scientists, cell manufacturing experts, and clinical research staff to conduct innovative early phase clinical trials according to Good Clinical Practice and all relevant institutional, state, and federal policies. We are seeking candidates with excellent communication skills, teamwork, and superb attention to detail. We strive for top-quality regulatory support of investigator-initiated clinical trials with a high degree of professionalism, initiative and flexibility. No two days are the same, but every day has an impact.

We are looking for someone who already has a strong foundation in regulatory affairs and human subjects research, and/or specialized knowledge of working with cellular therapies. RAC certification not required, but some previous coursework or prior jobs in regulatory affairs is expected. This position can offer a remote or hybrid work arrangement, including some days onsite and some at home each week. 

Duties include: 

• Lead the planning and operations for programs or functions that have significant business, regulatory and/or technical challenges requiring subject matter expertise. 
• Evaluate programs or functions, policies and procedures. Identify issues, and develop alternative solutions which may include changes to programs, policies and procedures. 
• Review and analyze trends to advise and develop recommendations to achieve or modify the goals of the program or function.
• Represent the program or function within the department, unit or school. Commit resources and provide information and/or training. Represent the program or function at the university level and/or to external/internal stakeholders and constituencies. 
• Manage and contribute to the development of outreach strategy that may include relationship development, communications and compliance.
• May develop and/or oversee budgets; manage finances including monitoring, analyzing, forecasting, and reporting.
• Assess training needs and may develop associated training.  

* - Other duties may also be assigned.

DESIRED QUALIFICATIONS:

Qualifications include a demonstrated understanding of human subjects research regulations, or extensive experience with clinical research in general. Previous experience writing protocols or other scientific writing, and/or experience with CAR-T cells or cellular therapy is desirable. Must be able to work occasionally on site at Stanford’s Palo Alto campus.

EDUCATION & EXPERIENCE (REQUIRED):

Bachelor's degree and five years of relevant experience, or combination of education and relevant experience.

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

• Demonstrated ability to establish priorities, manage shifting priorities, and handle numerous time-sensitive projects with multiple deadlines.
• Ability to accomplish goals working through formal and informal channels, with diplomacy and tactfulness.
• Demonstrated creativity, problem solving, critical analysis, initiative, judgment and, decision-making skills.
• Demonstrated ability to develop and meet budget goals.
• Demonstrated solid planning and organizational skills.
• Demonstrated experience working independently and as part of a team.
• Excellent interpersonal, written and oral communication skills.
• Strong relevant subject matter knowledge.
• Ability to direct the work of others, for jobs requiring supervision.

CERTIFICATIONS & LICENSES:

None required. RAPS or other regulatory affairs coursework 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.

WORKING CONDITIONS:

Remote and hybrid office work.

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 based 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 $73,000 to $141,000 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.

At Stanford University, base pay represents only one aspect of the comprehensive rewards package. The Cardinal at Work website (https://cardinalatwork.stanford.edu/benefits-rewards ) provides detailed information on Stanford’s extensive range of benefits and rewards offered to employees. Specifics about the rewards package for this position may be discussed during the hiring process.