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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:

  Ÿ Communication Ÿ Ownership Ÿ Understanding Ÿ Motivation Ÿ Sensitivity Ÿ Excellence Ÿ Teamwork Ÿ Respect

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

  Must possess the following personal qualities:

  Ÿ Be self-directed Ÿ Be flexible and committed to the team concept Ÿ Demonstrate teamwork, initiative, and willingness to learn Ÿ Be open to new learning experiences Ÿ Accepts and respects diversity without judgment Ÿ Demonstrates customer service values

  PHYSICAL DEMANDS/WORKING CONDITIONS :

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

Additional Information

• Organization: Henry Ford Medical Group

• Department: Infection Disease

• Shift: Day Job

• Union Code: Not Applicable

  Additional Details

  This posting represents the major duties, responsibilities, and authorities of this job, and is not intended to be a complete list of all tasks and functions. It should be understood, therefore, that incumbents may be asked to perform job-related duties beyond those explicitly described above.

Overview

Henry Ford Health partners with millions of people on their health journey, across Michigan and around the world. We offer a full continuum of services – from primary and preventative care to complex and specialty care, health insurance, a full suite of home health offerings, virtual care, pharmacy, eye care and other health care retail. With former Ascension southeast Michigan and Flint region locations now part of our team, Henry Ford’s care is available in 13 hospitals and hundreds of ambulatory care locations. Based in Detroit, Henry Ford is one of the nation’s most respected academic medical centers and is leading the Future of Health: Detroit, a $3 billion investment anchored by a reimagined Henry Ford academic healthcare campus. Learn more at henryford.com/careers .

Benefits

The health and overall well-being of our team members is our priority. That’s why we offer support in the various components of our team’s well-being: physical, emotional, social, financial and spiritual. Our Total Rewards program includes competitive health plan options, with three consumer-driven health plans (CDHPs), a PPO plan and an HMO plan. Our team members enjoy a number of additional benefits, ranging from dental and eye care coverage to tuition assistance, family forming benefits, discounts to dozens of businesses and more. Employees classified as contingent status are not eligible for benefits.

Equal Employment Opportunity/Affirmative Action Employer

Equal Employment Opportunity / Affirmative Action Employer Henry Ford Health is committed to the hiring, advancement and fair treatment of all individuals without regard to race, color, creed, religion, age, sex, national origin, disability, veteran status, size, height, weight, marital status, family status, gender identity, sexual orientation, and genetic information, or any other protected status in accordance with applicable federal and state laws.