Director, Clinical Trial Operations and Regulatory Affairs
The Sean N. Parker Center at Stanford University is seeking a Director, Clinical Trial Operations and Regulatory Affairs to provide strategic leadership and direction for complex Clinical Trials and cGMP Operations.
The Sean N. Parker Center for Allergy and Asthma Research at Stanford University is an interdisciplinary center with focus on understanding the mechanisms of the immune system, the dysfunctions of which result in allergic reactions. A leader in allergy research, our Center works collaboratively with other researchers around the world to create a data-sharing cluster of information from our interlinked satellite centers to run novel and innovative clinical trials in allergy research.
Our Center includes Stanford specialists in diverse fields including immunology, gastroenterology, otolaryngology, chemistry, bioengineering, pathology, pulmonology, and genetics. Through laboratory and computational research, clinical trials, community outreach, and other efforts, the team works toward finding rationally-based therapies to provide the safest and best treatments for allergies and asthma. Research at the Center may have implications for a wide array of immune dysfunctions including asthma, eczema, food allergies, eosinophilic disorders, drug allergies, gastroenterological diseases, and more.
- Make decisions regarding clinical research projects, programs, and initiatives. Develop and implement research goals for a clinical trial for a department or institute providing services to multiple faculty.
- Provide oversight and guidance on compliance with local, federal and international regulations on clinical research conduct.
- Select, develop, and evaluate personnel to ensure the efficient operation of the function including hiring, performance management, and related duties.
- Provide direction to PI’s, Clinical Research Managers on staffing needs, funding and resources in order to meet the needs of individual research efforts and overall research group.
- Clarify and resolve issues with substantial significance and impact, which may span multiple areas, using advanced clinical trials operations and Good Clinical Practice (GCP) knowledge.
- Provide direction for the clinical sites to establish protocol development. Review clinical practices, case report forms, and reports.
- Liaise with senior management ad cross functional areas and schools. Serve as a liaison to external organizations/agencies (FDA, NIH, Hospitals). Negotiate and establish external resource contracts.
- Manage and coordinate assigned multi-site or large-scale clinical trials research studies conducted by a supervising principal investigator(s) in support of actives that meet objectives of assigned research protocol(s).
- Access protocols internally, evaluate documentation for feasibility, conduct, and compliance. Provide expertise to improve protocol quality and completeness.
- Administer the budget, assign resources accordingly and assist with grant budget proposals.
* - Other duties may also be assigned
- Degree in nursing or advanced degree with ethics training and/or advanced degree with scientific training in research
- Knowledge of hypothesis-generating (omics) and experience in hypothesis-testing scientific research projects
- Knowledge and experience including General clinical experience Good Clinical Practices, and Conduct of Clinical Research Studies.
- Ability to run a high quality research organization, organizing and motivating teams who perform basic science research and clinical research.
- Experience developing and nurturing a growing organization, mentoring managers and project leaders, implementing processes, quality control mechanisms to ensure consistency across groups.
- Experience with improving quality, implementing metrics, and reporting results.
EDUCATION & EXPERIENCE (REQUIRED):
- Bachelor's degree plus five years of relevant experience, or combination of education and relevant experience.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
- Demonstrated experience leading and managing clinical trial staff.
- Demonstrated experience leading multi-site or large-scale clinical trials research.
- Ability to run a high quality clinical research organization, organizing and motivating teams to follow good clinical practice and regulatory requirements, while providing excellent patient care and study conduct.
- Demonstrated ability to work and communicate effectively with others, collaborate and build relationships across all levels of an organization.
- Project management experience in a research environment.
- Strong knowledge of industry standards and/or regulatory requirements.
- Knowledgeable about insurance billing, and the Medicare Coverage Act.
- Knowledge and experience including Good Clinical Practices, and Conduct of Clinical Research Studies.
- Excellent written, verbal, interpersonal, and presentation skills.
- Frequently sit, grasp lightly, use fine manipulation and perform desk-based computer tasks, lift, carry, push pull objects that weigh to ten pounds.
- Occasionally stand, use a telephone or write by hand.
- Rarely kneel, crawl, climb, twist, bend, stoop, squat, reach or work above shoulders, sort, file paperwork or parts, operate foot and hand controls.
* - 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.
Occasional local and overnight travel.
- Ensure consistency and adherence to clinical research guidelines, compliance with good clinical practices, good manufacturing practices and regulatory guidelines.
- 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.
Job Code: 4937
Employee Status: Regular
Requisition ID: 84090