"Senior Director, Clinical Operations"

Senior Director, Clinical Operations

The Stanford Cancer Institute’s Clinical Trials Office (SCI-CTO) is the centralized organization for cancer clinical research operations at Stanford Medicine. The SCI-CTO with over 200 staff provides high quality and efficient services supporting the development, activation, and completion of scientifically impactful cancer clinical trials serving the SCI’s catchment area.

The Senior Director, Clinical Operations leads the SCI-CTO clinical research operations organization by managing and overseeing all aspects of adult and pediatric clinical trials planning, study coordination and data management. This position is responsible for building and overseeing a team of highly skilled research staff to assure compliance with regulatory agencies, provide timely patient access to clinical trials; ensure data integrity and protocol adherence. This position collaborates closely with physician investigators and clinical research staff to drive successful implementation of cancer clinical trials. This position also collaborates with SCI-CTO colleagues and many others across Stanford Medicine and reports to the SCI-CTO Executive Administrative Director. This integral leadership role will be a great fit for you if you are someone who is energized by leading a team, collaborating for results, driving changes, and are passionate about making a difference.

Given the patient facing nature of cancer clinical research, this position is based on the Stanford Medicine campus with options for some hybrid work.

The SCI earned its most recent comprehensive cancer center designation by the NCI in 2022, and is a prominent, growing and complex Institute within Stanford Medicine. Cancer clinical research is integrated throughout Stanford Medicine which is comprised of Stanford School of Medicine and our adult and pediatric health systems – Stanford Health Care and Stanford Children’s Health. The SCI actively works to build synergies and collaborations across Stanford Medicine. Given the SCI’s mission, breadth, and depth, we thrive in a fast-paced, team-oriented, and forward-thinking environment with tremendous opportunities for personal and professional growth. You will be working with a leading-edge community of faculty and staff who are fundamentally changing the world of health care in the cancer arena.

Job Responsibilities:

• Contribute to strategy and direction to establish objectives for the overall cancer clinical research operation of the SCI-CTO.
• Determine staffing levels, select, develop, and evaluate personnel to ensure the efficient operation of the function including hiring, performance management, and related duties.
• Identify, clarify, and resolve issues with strategic impact and substantial significance, which may span multiple areas, using advanced clinical trials operations and Good Clinical Practice (GCP) knowledge requiring broad discretion and judgment.
• Implement and maintain quality control standards, and evaluate program effectiveness.
• Collaborate with Stanford Medicine leaders on the direction of clinical research and operational objectives. Develop strategies to ensure effective achievement of objectives (both short and long term).
• Serve as a liaison to external organizations/agencies.
• Monitor affiliated sites to ensure faculty, administration, and staff meet educational and regulatory requirements for participation in clinical research.
• Manage operational budget, assign resources within budget constraints, secure resources for new initiatives, report on financial health of operations.
• *Other duties as may be assigned*

DESIRED QUALIFICATIONS:

• Demonstrated leadership experience of clinical trials and research teams.
• Oncology clinical operations experience.
• Academic clinical research experience.
• Advanced degree in nursing or other relevant fields preferred.
• Demonstrated experience building, leading, motivating, and managing a high performing team comprised of multiple position and experience levels.
• Advanced knowledge and understanding of concepts, policies and processes, and regulatory requirements associated with the development, implementation, and administration of multi-site or large-scale clinical trials and complex projects.
• Experience in adherence to GCP and other federal, state, and local regulations pertaining to human subject research.
• Knowledge of policies and regulations relevant to clinical trial management systems, electronic medical records, and clinical research billing practices.
• Strong attention to detail and organization with the ability to manage large volumes of information and competing priorities.
• Demonstrated ability to interact with and influence internal and external stakeholders with excellent independent judgment and decision-making skills.
• Demonstrated leadership, mentoring, training, planning, and change management skills.
• Demonstrated expertise in project management and analytical problem solving, with strong interpersonal, critical thinking, and communication skills. Ability to present ideas and information effectively.

EDUCATION & EXPERIENCE (REQUIRED):

Bachelor’s degree plus eight years of relevant experience or combination of education and relevant experience.

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

• Demonstrated experience leading and managing staff and/or managers.
• Demonstrated experience leading multi-site or large-scale clinical trials research.
• Management experience with developing strategies and leading the administrative and financial operations of a large academic or industry-based clinical research organization.
• Demonstrated ability to interact and influence internal senior leadership and external stakeholders.
• Demonstrated leadership, planning, project management and change management skills.
• Strong knowledge of industry standards and/or regulatory requirements.
• Demonstrated expertise in analytical problem solving and negotiating experience.
• Knowledge and experience including Good Clinical Practices, and Conduct of Clinical Research Studies.
• Demonstrated analytic and critical thinking skills, writing skills, communication skills and consulting skills.

CERTIFICATIONS & LICENSES:

• Clinical Research Certification (SoCRA, ACRP, or equivalent) preferred.
• Advanced Practice Provider (APP) certification preferred.

PHYSICAL REQUIREMENTS*:

• 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.

WORKING CONDITIONS:

Occasional local and overnight travel.

WORK STANDARDS:

• 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.

The expected pay range for this position is $195,687 to $293,100 per annum.