Executive Director OMEGA

POSITION OBJECTIVE

The Executive Director of OMEGA will serve as strategic leader for the Orchestrating Multifaceted Engineering for Growing Artificial Joints (OMEGA) program. This position will provide national and regional leadership for establishing the OMEGA program at Case Western Reserve University. The executive director will develop and champion a shared vision, establish organizational goals, create strategic plans, and set long range direction for OMEGA. The executive director will be responsible for management of all administrative requirements across the OMEGA program to ensure timely completion of milestones and deliverables at all sites. The executive director will have deep experience in the orthopedics or related medical device development, experience in managing complex budgets, and project management expertise. The executive director will serve the primary point of contact with local principal investigators, the subcontract principal investigators, consultants, and grants management specialists of the consortium members. The executive director will regularly communicate with the program managers and staff members at the federal government, including the FDA. In coordination with the principal investigator of OMEGA, the executive director be responsible for monitoring and maintaining progress of all sites and the incorporation of all progress into complex and multifaceted scientific and financial progress reports for federal funding agencies. The executive director will lead the project planning to identify critical path activities and work ahead of investigators to fast-forward contracts, equipment, and supplies, to ensure research progresses on the fastest path possible. Additionally, the executive director will facilitate data sharing, establish a cadence of meetings with investigators of the consortium to drive performance against timely completion of milestones/sub-milestones and deliverables. The Executive Director will work closely with OMEGA principal investigator, Senior Vice President for Research and Technology Management, the Executive Advisory Board, and university leadership to ensure the ultimate success of the OMEGA program in clinical and commercial translation of the artificial joint through the clinical trial.

OMEGA (Orchestrating Multifaceted Engineering for Growing Artificial Joints) is a megaproject that involves more than a dozen academic institutions, companies, and consulting entities around the nation. The consortium has a significant footprint in Northeastern Ohio by way of inclusion of eleven faculty members from Case Western Reserve University, University Hospitals of Cleveland and the Louis Stokes Cleveland Veteran’s Administration Medical Center. OMEGA’s mission is to reduce an artificial knee joint concept to practice through prototyping, good laboratory practice testing, FDA approvals, good manufacturing practice and Phase I clinical trial over five years. Developmental efforts also include establishment of the intellectual property and commercialization foundations for transitioning the concept as a clinical product while keeping the equitable translation of the technology.

ESSENTIAL FUNCTIONS

NONESSENTIAL FUNCITONS

Perform other duties as assigned (5%)

CONTACTS

Department: Weekly, occasionally daily, contact with the principal investigator of the OMEGA program. Daily contact with OMEGA staff to maintain workflow.

University: Regular contact with the leaderships of schools and departments and faculty who are affiliated with the OMEGA consortium. Occasional interactions with senior vice president for research and technology management and the associate vice president for research to coordinate central support to OMEGA operations. Regular contact with the office of Research and Technology Management. Contact with directors of relevant centers and departments across the campus.

External: Frequent contact with partners of OMEGA at the University Hospitals of Cleveland and Louis Stokes Cleveland VA Medical Center, partnering Academic Institutions, scientific staff member and C-suites of relevant start-up companies, consulting companies, executive advisory board members, entrepreneurs, surgeons, healthcare reimbursement experts, GMP manufacturing candidates and investors. Regular contact with funding agencies from Health and Human Services, occasional contact with scientific and administrative staff from the Food and Drug Administration. Occasional contact with federal government representatives from NIST, DoD and NSF program directors, center directors, and administrators. Contact with representatives of local, national, and international companies as well as representatives of private investments (e.g., investors, venture capital, angel investors, etc.).

Students: No contact with students

SUPERVISORY RESPONSIBILITIES

Supervise 2 administrative staff to serve the consortium members.

QUALIFICAITONS

Experience: 20 or more years of experience in orthopedic device development, including 5 years of experience in the orthopedic industry, required.

Education: Master’s degree or higher required, preferably in engineering field.

REQUIRED SKILLS

WORKING CONDITIONS

General work environment that includes normal office activities, speaking engagements, and university meetings. Travel as needed for meetings, workshops, conferences, and other business.

In employment, as in education, Case Western Reserve University is committed to Equal Opportunity and Diversity.  Women, veterans, members of underrepresented minority groups, and individuals with disabilities are encouraged to apply.

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Case Western Reserve University provides reasonable accommodations to applicants with disabilities.  Applicants requiring a reasonable accommodation for any part of the application and hiring process should contact the Office of Equity at 216-368-3066 to request a reasonable accommodation.  Determinations as to granting reasonable accommodations for any applicant will be made on a case-by-case basis.

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