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Senior Regulatory Specialist

School of Medicine, Stanford, California, United States

New

Administration

Post Date 1 day ago

Requisition # 105522

Stanford University is one of the world’s most renowned universities. Sitting in the heart of the San Francisco Bay Area among the valley’s most progressive companies.

You will be working with an unparalleled leading-edge community of faculty and staff that are fundamentally changing the world of health care. You will have the opportunity to influence and drive change with your innovative ideas, the ability to make a difference and participate in human advancements. Our culture is fast-paced, energetic, and growing all of the time.

We offer a variety of benefits beyond traditional medical, dental, retirement, and savings options:

• Events and program for children, sports camps, tuition options

• World-class intellectual stimulation through learning and development classes, workshops, and onsite conferences from leading-edge speakers and faculty

• Work/life and family-friendly policies and reimbursement

• Participation in Stanford’s social responsibility and sustainable programs for a better world

• A vibrant university culture that values the uniqueness of each individual

We are seeking candidates who are progressive thinkers, see challenges as simply problems to solve, and have the spirit and energy to change the world.

About the Department of Pathology

The Department of Pathology at Stanford School of Medicine, one of its founding departments, stands as a leader among its peers nationwide. Our preeminent faculty spans from emerging leaders to highly accomplished physicians and scientists, including a Nobel laureate and members of the National Academy. Our mission is to improve the diagnosis, treatment, and basic understanding of the human disease. This is done through discovery (research), education, and clinical care. Comprised of extraordinary faculty and staff, our mission is to improve the ability to diagnose, treat and understand the origin andmanifestation of human disease, and to care for those who have or are at risk to develop disease. We accomplish this through ourclinical services (in all fields of anatomic and clinical pathology, including molecular and genomic pathology, histocompatibilitytesting and transfusion medicine) and be research (which includes basic, translational and clinical research into the origins andmanifestations of disease, including efforts to improve disease prediction and prevention as part of the goal of achieving precisionmedicine and health), and also by educating future leaders in pathology and related fields. Everything we do is to achieve the goalsof providing the highest quality of clinical services to the patients for whom we passionately care, to advance our ability tounderstand, diagnose, monitor and ultimately to cure disease or to prevent or delay its occurrence, and to provide outstandingeducation and career development opportunities to those who share these goals.

For more information about the department visithttp://pathology.stanford.edu/

About the Center:

The Sean N. Parker Center for Allergy and Asthma Research at Stanford University is the first of its kind, dedicated to advancing treatments and discovering underlying immune mechanisms to develop lasting cures for allergies and asthma in both children and adults. Our interdisciplinary team of leading scientists, physician-scientists, and specialists from fields such as immunology, gastroenterology, otolaryngology, chemistry, bioengineering, pathology, pulmonology, and genetics collaborates on cutting-edge research aimed at understanding immune dysfunction that leads to allergic reactions.

As a global leader in allergy research, our Center works collaboratively with researchers worldwide, sharing data through an interlinked network of satellite centers to conduct innovative clinical trials. Our research efforts extend beyond allergies and asthma to encompass a range of immune-related disorders, including eczema, food allergies, eosinophilic conditions, drug allergies, and gastrointestinal diseases.

Through laboratory and computational research, clinical trials, and community outreach, we are committed to developing rational, evidence-based therapies that provide the safest and most effective treatments for patients. By combining innovative science with compassionate care, we strive to transform lives at both local and global levels.

About the Position:

The Sean N. Parker Center for Allergy and Asthma Research at Stanford University is seeking a Senior Regulatory Specialist to manage the oversight of all regulatory activities under the direction of project researchers, investigators, or managers.

The Sr Regulatory Specialist will join a team of researchers that leads or participates in many clinical trials to develop new therapies for allergic disorders and immune conditions. The studies include a wide range of patients, representing a diverse group of ethnicities and socioeconomic backgrounds. The Center is aiming not only to find better treatments for children and adults with allergies and asthma, but to discover underlying immune mechanisms against the diseases and develop a lasting cure. Primary responsibilities as a Sr Regulatory Specialist will include the oversight and management of all regulatory activities including overseeing IRB submissions, prompt reporting, annual reports to the IRB, DSMB, and FDA, and mentoring the research staff on regulatory topics to ensure Center adherence to all regulatory aspects of all SNP Center studies and grants.

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.

• May direct and/or supervise staff.

- Other duties may also be assigned

Desired Qualifications:

• Experience in managing the Investigator Site File for complex, multi-site studies as Site Sponsor

• Certified Clinical Research Professional (CCRP)

• Certified in Clinical Research Monitoring

• Experience submitting and managing Investigational New Drug (IND) applications

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.

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*:

• This position may have a flexible work location, with the possible ability to be either co-located near the Stanford campus in Palo Alto, CA as a hybrid worker.

The expected pay range for this position is $116,849 to $148,275 per annum at 100% FTE.

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.

Why Stanford is for You

Imagine a world without search engines or social platforms. Consider lives saved through first-ever organ transplants and research to cure illnesses. Stanford University has revolutionized the way we live and enrich the world. Supporting this mission is our diverse and dedicated 17,000 staff. We seek talent driven to impact the future of our legacy. Our culture and unique perks empower you with:

• Freedom to grow. We offer career development programs, tuition reimbursement, or course auditing. Join a TedTalk, film screening, or listen to a renowned author or global leader speak.

• A caring culture. We provide superb retirement plans, generous time-off, and family care resources.

• A healthier you. Climb our rock wall or choose from hundreds of health or fitness classes at our world-class exercise facilities. We also provide excellent health care benefits.

• Discovery and fun. Stroll through historic sculptures, trails, and museums.

• Enviable resources. Enjoy free commuter programs, ridesharing incentives, discounts and more

The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned.

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.

Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.

Additional Information

• Schedule: Part-time

• Job Code: 4122

• Employee Status: Regular

• Grade: J

• Requisition ID: 105522

• Work Arrangement : On Site