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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

Partnering with nearly 2 million people on their health journey, Henry Ford Health provides a full continuum of services at 250 care locations throughout southeast and south central Michigan. With 33,000 valued team members, Henry Ford is also among Michigan’s largest and most diverse employers. Our superior care and discoveries are powered by nearly 6,000 physicians, researchers and advanced practice providers. Learn more athenryford.com.

Benefits

Whether it's offering a new medical option, helping you make healthier lifestyle choices or making the employee enrollment selection experience easier, it's all about choice. Henry Ford Health has a new approach for its employee benefits program - My Choice Rewards. My Choice Rewards is a program as diverse as the people it serves. There are dozens of options for all of our employees including compensation, benefits, work/life balance and learning - options that enhance your career and add value to your personal life. As an employee you are provided access to Retirement Programs, an Employee Assistance Program (Henry Ford Enhanced), Tuition Reimbursement, Paid Time Off, Employee Health and Wellness, and a whole host of other benefits and services. Employee's 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.