"IND/IDE Office Assistant Director"

IND/IDE Office Assistant Director

University of Colorado Anschutz Medical Campus

Department: Clinical Research Operations and Services

Position #: 00800339 - 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.

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.

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):

1. A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position
2. Curriculum vitae / Resume
3. 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.