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Stanford University · 2 days ago

Senior Director, Clinical Operations

Stanford, CA

Full-time

Hybrid

Director/Executive

$196K/yr - $293K/yr

8+ years exp

Stanford University is a leading institution in cancer research, and they are seeking a Senior Director for their Clinical Operations. This role involves overseeing the clinical research operations for cancer clinical trials, managing a skilled team, ensuring compliance with regulatory agencies, and collaborating with various stakeholders to drive successful trial implementations.

EducationHigher EducationUniversities

Growth Opportunities

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

Qualification

Clinical trials leadershipOncology clinical operationsClinical Practice (GCP)Project managementAnalytical problem solvingClinical research experienceTeam buildingChange managementCommunication skillsInterpersonal skills

Required

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

Demonstrated leadership experience of clinical trials and research teams

Oncology clinical operations experience

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

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

Preferred

Advanced degree in nursing or other relevant fields preferred

Clinical Research Certification (SoCRA, ACRP, or equivalent) preferred

Advanced Practice Provider (APP) certification preferred

Benefits

Stanford University provides pay ranges representing its good faith estimate of the salary or hourly wage the university reasonably expects to pay for a position upon hire.

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.