University of Colorado · 1 month ago
IND/IDE Office Assistant Director
Aurora, CO
Full-time
Hybrid
Mid, Senior Level
$89K/yr - $113K/yr
6+ years expThe University of Colorado Anschutz Medical Campus is seeking an IND/IDE Office Assistant Director to oversee the IND/IDE office, focusing on regulatory strategy and compliance. This high-impact role involves supervising staff, managing clinical research initiatives, and collaborating with various stakeholders to facilitate innovative therapies.
EducationHigher EducationUniversities
Responsibilities
This position will supervise staff on the IND/IDE team
Manage an IND/IDE office that is responsible for oversight of all locally held IND/IDEs on campus including for products manufactured on campus
Aid in the onboarding process for IND/IDE staff
Design a cascading goal setting and performance infrastructure that ensures individual alignment to the strategic plan and fosters personal and professional growth
Develop and implement SOPs, training programs, and quality management systems for the IND/IDE office
Oversee preparation, submission, and maintenance of INDs and IDEs for early-phase and first-in-human studies performed on the CU Anschutz Campus Operations
Collaborate with investigators, IRBs, research administration, and legal teams to navigate regulatory pathways for novel therapeutics and devices
Convene and lead teams to develop and execute organization-wide initiatives, including the successful implementation of cellular therapy clinical trials through the IND/IDE office
Provide oversight of appropriate financial controls and fiduciary stewardship to determine areas vulnerable from an audit perspective and develop plans, recommendations, policies, and procedures to strengthen those areas
Evaluate, select, and manage external regulatory consultants supporting translational research initiatives by developing and providing strategic regulatory guidance for projects in which the Anschutz Medical Campus leads or participates, including complex multi-institutional research awards
Oversight of external consultants developing regulatory strategy
Work with University Communications to communicate study milestones and progress, ensuring transparency, accountability, and strategic context
Ensure timely communication and appropriate escalation unresolved obstacles to trial opening
Work closely with the OVCR and IND/IDE staff to ensure projects are appropriately resourced
Ensure the leadership team is continually apprised of the strategic landscape—within the team and external—to anticipate and capitalize on existing and emerging strengths and opportunities and address weaknesses and potential threats
Act as a change agent and serve as a major point of contact for problem resolution
Develop and manage efficient and effective policies, procedures, and processes to facilitate investigator initiated, FDA regulated clinical research on campus in a compliant and customer focused manner
Work closely with the Assistant Vice Chancellor for Clinical Research Operations to engage and partner with key research leaders on campus including the Cancer Center, Gates Institute, CHCO, and UCHealth to develop and optimize this effort
Assess the ongoing needs in this area and develop/implement a long-term strategic plan for the sustainability of IND/IDE office
Develop an effective approach to identifying, tracking, and reporting metrics that illuminate progress toward goals and build organizational energy around our strategic ambitions
Partner with stakeholders to set a successful strategic agenda that identifies opportunities, prioritizes ambitions, and sustains progress over time
Qualification
Required
A bachelor's degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, finance, accounting, business administration, business, data sciences/quantitative field or a directly-related field from an accredited institution
At least 6 years of experience working with various business functions including project and program management, goal setting, benchmarking, and strategic planning
Experience with executive-level leadership to identify, prioritize, and execute strategic opportunities
Proven track record managing INDs/IDEs and interacting with FDA
Experience in the academic research environment
A combination of education and related technical/military/paraprofessional experience may be substituted for a bachelor's degree on a year for year basis
Applicants must meet minimum qualifications at the time of hire
Preferred
Master's degree in business administration, public administration, public health, accounting, finance, data sciences/quantitative field or equivalent
Certified as a Clinical Research Professional (CCRP)
Regulatory Affairs Certification (RAC) for drugs and devices
Prior experience managing investigator initiated multi-center studies
Past operational experience in FDA-regulated clinical trials management
Experience working with federal regulations related to clinical research, Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), Good Laboratory Practice (GLP), and in Chemistry, Manufacturing, and Controls (CMC) related work
Experience in managing multiple projects simultaneously or previous work in a project management office role
Project and Program management experience specifically in an academic environment
Benefits
Medical: Multiple plan options
Dental: Multiple plan options
Additional Insurance: Disability, Life, Vision
Retirement 401(a) Plan: Employer contributes 10% of your gross pay
Paid Time Off: Accruals over the year
Vacation Days: 22/year (maximum accrual 352 hours)
Sick Days: 15/year (unlimited maximum accrual)
Holiday Days: 10/year
Tuition Benefit: Employees have access to this benefit on all CU campuses
ECO Pass: Reduced rate RTD Bus and light rail service
Company
University of Colorado
University of Colorado offers higher education and serving as the catalysts in business, arts, health, and community growth.
10001+ employees
H1B Sponsorship
University of Colorado has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (184)
2024 (124)
2023 (163)
2022 (115)
2021 (86)
2020 (95)
Funding
Current Stage
Late StageTotal Funding
$0.5MKey Investors
US Department of EnergyUS Department of Commerce, Economic Development Administation
2023-07-27Grant
2023-01-26Grant
2021-04-06Grant· $0.5M
Leadership Team
Richard Schulick
Professor and Chair of Surgery
Recent News
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2025-12-28
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