Director, Oncology Research

• Monday - Friday

• Full time, days

A senior member of the clinical trials leadership team that provides strategic direction, develops and communicates vision for the department, shares expertise across multiple discipline, creates an environment of continuous improvement by defining business needs and driving transformational change, sponsors and leads innovative projects and uses project management methodologies to position LCI for success, helps develop and lead enterprise strategy through programmatic, geographic, technical and operational assessments and planning.

• Demonstrates expert knowledge of Good Clinical Practices (GCP), International Conference on Harmonization (ICH) Guidelines, as well as applicable rules/regulations pertaining to research. Knowledge of regulatory requirements of the Food and Drug Administration (FDA), Institutional Review Board (IRB), and Office of Human Subjects Protections (OHRP) pertaining to clinical research.

• Assists in developing the operational budget for the LCI Clinical Trials Department

• Provides strategic direction and oversight for clinical trial projects which are enterprise-wide and assists with strategic planning for both the enterprise-wide growth of clinical trials and associated operations.

• Performs metric analysis to ensure research workload for clinical trial operations meets the overall research team objectives.

• Responsible for comprehensive Time and Effort reporting requirements to Research Finance ensuring research time is allocated appropriately.

• Ensures all clinical trial operations are in compliance with ICH, GCP and FDA requirements.

• Ensures appropriate documentation is maintained to meet applicable federal regulatory requirements as well as trial sponsor requirements.

• Ensures the department is prepared for sponsor and governmental audits and inspections.

• Provides updates to executive stakeholders on current/forecasted resource requirements, accrual status, financial performance, investigator performance, etc. through formal presentations and reports.

• Develops and monitors performance reports related to the trials portfolio (includes sponsor and CRO reports, corporate financial performance, corporate HR reports, CTMS-based reports, key performance indicators, etc.).

• Primarily works in an office setting.

• Requires full range of body motion; sitting for extensive periods of time; walking, standing, reading, and writing/keyboarding.

• Occasionally lifts and carries items weighing up to 35 pounds. Requires corrected vision and hearing within normal range.

• Must speak and read/write clearly in English.

• Must be able to be mobile within the entire healthcare system and other locations that participate in LCI clinical trials.

• Bachelor's Degree required, health/science preferred with minimum of 15 years of directly-related clinical trials experience with a pharmaceutical company, Contract Research Organization (CRO), research center or equivalent required; management experience required; oncology experience required.

• RN not required, however RNs must hold a current applicable state nursing license and current CPR certification.

Advocate Health offers a comprehensive suite of Total Rewards: benefits and well-being programs, competitive compensation, generous retirement offerings, programs that invest in your career development and so much more – so you can live fully at and away from work, including:

Advocate Health is the third-largest nonprofit, integrated health system in the United States, created from the combination of Advocate Aurora Health and Atrium Health. Providing care under the names Advocate Health Care in Illinois; Atrium Health in the Carolinas, Georgia and Alabama; and Aurora Health Care in Wisconsin, Advocate Health is a national leader in clinical innovation, health outcomes, consumer experience and value-based care. Headquartered in Charlotte, North Carolina, Advocate Health services nearly 6 million patients and is engaged in hundreds of clinical trials and research studies, with Wake Forest University School of Medicine serving as the academic core of the enterprise. It is nationally recognized for its expertise in cardiology, neurosciences, oncology, pediatrics and rehabilitation, as well as organ transplants, burn treatments and specialized musculoskeletal programs. Advocate Health employs 155,000 teammates across 69 hospitals and over 1,000 care locations, and offers one of the nation’s largest graduate medical education programs with over 2,000 residents and fellows across more than 200 programs. Committed to providing equitable care for all, Advocate Health provides more than $6 billion in annual community benefits.