Medical Director, Central Clinical Trials Office

GENERAL SUMMARY:

The Medical Director, Central Clinical Trials Office (MDCTO) in the Office of Research Administration (ORA) at Henry Ford Health System (HFHS) will be responsible for the overseeing and enhancing the performance of clinical trials across HFHS, in close partnership with the VP, Research (VPR) and clinical research leaders across the system, and assuring an efficient and effective environment in which to conduct clinical trials, while ensuring compliance with federal and state regulatory requirements. The Position will report to the VPR/Chief Scientific Officer of HFHS.

The MDCTO will work closely with the Director of the Centrial Clinical Trials Office to oversee Clinical Trial policy development and compliance, ensuring that all research is conducted according to federal and other regulatory standards (e.g. FDA Good Clinical Practice (GCP), International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Office for Human Research Protections (OHRP), Joint Commission, Centers for Medicaid and Medicare Services (CMS), Association for the Accreditation of Human Research Protection Programs (AAHRP), etc.).

Success will require close collaboration with the clinical departments, research administration divisions (e.g. IRB, contracting and Biorepository), and other units that support the development and execution of clinical research studies.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

The MDCTO is charged with helping facilite infrastructure, processes, and analytics to assure that HFHS is a leader among academic health systems from the perspective of clinical investigators as well as sponsors and governmental grantors, and driving a strategic growth agenda to increase the number of high-impact trials HFHS conducts.

· Collaborate with the VPR/CSO to establish the vision, strategic goals and priorities for the CTO

· Partner with clinical department chairs, division chiefs, and center/institute directors to pursue a growing, diverse portfolio of high-impact trials

· Oversee a high-performance, customer-oriented centralized infrastructure that supports investigators to design and execute clinical research studies

· Develop and maintain performance expectations and metrics and drive continuous improvement in processes and infrastructure that underpin clinical research at HFHS

EDUCATION/EXPERIENCE/SKILLS REQUIRED:

· MD/DO degree

· History of successful clinical trial activity from diverse funding sources, including both Federal and private sector.

· Deep knowledge of protocol / study development as well as all regulatory guidelines applicable to clinical trials.

· Experience in the IRB process strongly preferred.

· At least 10 years' experience in clinical trials with direct oversight of clinical trial operations.

· Strong track record of achievement as an investigator in clinical trials and translational research

· Skill in building and maintaining collaborative relationships with physician investigators as well as clinical research support personnel

• Excellent leadership skills and ability to drive results

CERTIFICATIONS/LICENSURES REQUIRED:

Must meet or exceed core customer service responsibilities, standards and behaviors as outlined in the HFHS' Customer Service Policy and summarized below:

Communication Ownership

Understanding Motivation

Sensitivity Excellence

Teamwork Respect

Must practice the customer skills as provided through on-going training and in-services.

Must possess the following personal qualities:

Be self-directed

Be flexible and committed to the team concept

Demonstrate teamwork, initiative, and willingness to learn

Be open to new learning experiences

Accepts and respects diversity without judgment

Demonstrates customer service values

PHYSICAL DEMANDS/WORKING CONDITIONS :

Normal office environment with minimal exposure to noise, dust, or extreme temperatures.

• Organization: Henry Ford Medical Group
• Department: Infection Disease
• Shift: Day Job
• Union Code: Not Applicable