Job Details

University of Colorado Anschutz Medical Campus

IND/IDE Office Assistant Director

Position Number: 6799163
Location: Aurora, CO
Position Type: Laboratory and Research

IND/IDE Office Assistant Director

IND/IDE Office Assistant Director - 38540 University Staff Description

University of Colorado Anschutz Medical Campus

Department: Clinical Research Operations and Services

Job Title:

Position #:- Requisition #: 38540

Job Summary:

Reporting to the Assistant Vice Chancellor for Clinical Research Operations in the Office of the Vice Chancellor for Research (OVCR), the IND/IDE Office Assistant Director is a high impact and high visibility role, responsible for developing, managing, and overseeing the activity for the IND/IDE office, including regulatory strategy. This position will work closely with other leaders in the OVCR, Cancer Center, Gates Institute, and CHCO to support CU held INDs and CU investigator-held INDs.

Key Responsibilities:

Supervision/Day to Day Office Oversight

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.

Strategic Development

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.

Work Location:

Hybrid - this role is eligible for a hybrid schedule of 2 days per week on campus and as needed for in-person meetings.

Why Join Us:

The mission of this group is to partner with CU Anschutz investigators and stakeholders to develop innovative therapies and facilitate the regulatory and operational conduct of clinical trials. This role requires expertise in FDA regulations (21 CFR Parts 312, 812) and serves as a primary liaison among investigators, sponsors, regulatory agencies, and institutional stakeholders.

Why work for the University?

We have AMAZING benefits and offer exceptional amounts of holiday, vacation and sick leave! The University of Colorado offers an excellent benefits package including:

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

There are many additional perks & programs with the CU Advantage.

Qualifications:

Minimum Qualifications:

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 Qualifications:

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

Knowledge, Skills and Abilities:

Demonstrated strong judgment in assessing consultant expertise and value for complex regulatory challenges
Ability to communicate effectively, both in writing and orally.
Ability to establish and maintain effective working relationships with employees at all levels throughout the institution.
Outstanding customer service skills.
Deeply focused and results-oriented
Keen understanding of strategy and ability to envision the future
Nimble business mind with a focus on developing creative solutions
Ability to analyze complex problems and recommend or implement an effective course of action
Ability to plan, prioritize and oversee multiple projects, meet deadlines for deliverables Strong financial acumen
Strong critical thinking and problem-solving skills required
Experience managing process improvement projects
Ability to learn quickly and understand new technical concepts and processes
Exceptional multi-tasking and organizational skills, as well as the ability to make complex decisions in a fast-paced environment
Must possess a professional demeanor
Detail oriented
Excellent interpersonal skills
Self-motivated and able to work in a team environment
Personable, friendly, and able to work well under pressure, especially when assisting involved stakeholders
Excellent communication skills in both written as well as presentation of data
Proficiency in Microsoft Suite

How to Apply:

For full consideration, please submit the following document(s):

A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position
Curriculum vitae / Resume
Three to five professional references, including name, address, phone number (mobile number if appropriate), and email address

Questions should be directed to: Benjamin Echalier, Benjamin.Echalier@cuanschutz.edu

Screening of Applications Begins:

Immediately and continues until position is filled. For best consideration, apply by December 30, 2025.

Anticipated Pay Range:

The starting salary range (or hiring range) for this position has been established as $88,895 - $113,075.

The above salary range (or hiring range) represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting. This position may be eligible for overtime compensation, depending on the level.

Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line.

Total Compensation Calculator

Equal Employment Opportunity Statement:

CU is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws governing nondiscrimination in employment. We are committed to creating a workplace where all individuals are treated with respect and dignity, and we encourage individuals from all backgrounds to apply, including protected veterans and individuals with disabilities.

ADA Statement:

The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at hr.adacoordinator@cuanschutz.edu.

Background Check Statement:

The University of Colorado Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees.

Vaccination Statement:

CU Anschutz strongly encourages vaccination against the COVID-19 virus and other vaccine preventable diseases. If you work, visit, or volunteer in healthcare facilities or clinics operated by our affiliated hospital or clinical partners or by CU Anschutz, you will be required to comply with the vaccination and medical surveillance policies of the facilities or clinics where you work, visit, or volunteer, respectively. In addition, if you work in certain research areas or perform certain safety sensitive job duties, you must enroll in the occupational health medical surveillance program.

Application Materials Required: Cover Letter, Resume/CV, List of References Job Category
: Research Services Primary Location
: Hybrid Department: U0001 -- Anschutz Med Campus or Denver - 21976 - ADM AVC Clinical Res Operation Schedule
: Full-time Posting Date
: Dec 17, 2025 Unposting Date
: Ongoing Posting Contact Name: Benjamin Echalier Posting Contact Email: Benjamin.Echalier@cuanschutz.edu Position Number: 00800339

To apply, visit https://cu.taleo.net/careersection/2/jobdetail.ftl?job=38540&lang=en