Job Summary:

The Gates Institute is seeking a full time Associate Director or Director who will be primarily responsible for establishing the strategic direction and tactical approach to operationalizing clinical trials by focusing on the people and processes. The Associate Director or Director will be a senior member of the Gates Institute’s leadership team; they will build and maintain strong and impactful relationships, while working cross-functionally and collaboratively to oversee planning, management, and execution of trial activities.

At the Director level, this role will strategically lead clinical research operations for the Gates Institute, including oversight of mission critical strategic planning, finances, and human resources, with guidance from the Director of Finance & Administration of the Gates Institute.

Key Responsibilities:

Leadership and Strategy (20%):

• Champions the development and execution of a strategic and tactical plan to operationalize clinical trials for each Gates Institute product by providing expertise, leadership, strategic planning, and financial oversight.
• Designs a cascading goal setting and performance infrastructure that ensures individual alignment to the strategic plan and fosters personal and professional growth.
• Develops and implements Gates Institute guidelines and policies in the sector of clinical research, and ensures projects are appropriately resourced.
• Recruit, supervise, develop, and mentor members of the Clinical Research team including hiring, compensation, termination, and performance, with the guidance from the Director of Finance & Administration.
• Partners with relevant campus clinical research leaders to establish standardized processes for performing high quality clinical trials within their functional areas as warranted by the Gates Institute product portfolio.

Director Level: In addition to the duties above…

• In support of the mission of the University of Colorado, Anschutz Medical Campus, this role will lead clinical research initiatives and manage long- and short-term strategic planning in direct support of ongoing clinical trial advancements and operations.
• Manage strategic staffing for Clinical Trials team.
• In collaboration with Gates leadership, this role will be responsible for financial planning and projections, budget development and management, year-end budget analysis and close-out, etc.

Communication and Education (20%, Both Levels):

• Develops and provides education to site teams and other stakeholders on phase 1 clinical trial protocols and standardized processes.
• Provides a channel of communication between teams specializing in preclinical work, manufacturing, and clinical work, including trial design, safety and regulatory oversight, data management, and execution of clinical trials.
• Establishes and maintains communication and collaboration with the key stakeholders in the office of the Vice Chancellor for Research regarding issues relevant to patients and projects associated with the Gates Institute.
• Work with Gates Institute Communication Manager to communicate trial milestones internally and externally, as appropriate.

Operations and Continuous Improvement (20%, Both Levels):

• Works with the disease specific clinical research teams to develop study flows consistent with the protocol and clinic – level practices. Reviews new protocols and amendments for patient inclusion and operational feasibility. Ensures protocol procedures are feasible in the local clinical environment.
• Develops and strengthens resources, programs, and services to optimize clinical research with a continuing focus on process and quality improvement.
• Identifies, tracks, and analyzes barriers in current clinical trials processes and conceptualizes and executes process improvements.

Clinical Trial Management (20%, Both Levels):

• Serves as trial development and trial management lead, collaborating with scientists, Principal Investigators, physicians, scientific writers, site teams, regulatory compliance, manufacturing experts, and other entities on campus to bring Gates Institute products successfully and efficiently to patients.
• Develops study support materials including lab manuals, protocol-related procedure forms, case report forms, needed appendices, investigator’s brochures, etc. as needed.

Patient Safety Oversight (20%, Both Levels):

• In collaboration with Gates Institute Medical Lead(s), verifies patients meet all eligibility criteria; verifies and reviews adverse events, serious adverse events, and other trial data, and ensures accurate reporting in accordance with the protocol.
• Tracks, documents, and updates stakeholders on status of study participants.
Reports adverse event data to relevant stakeholders, including Safety Monitoring Committee.

Work Location:

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

Why Join Us:

The opportunity offered by the Gates Institute is one of a kind. We blend the best of a large research organization of over 40,000 employees strong, with the family atmosphere of working with a team of 50 highly dedicated people, operating on a top tier research campus – the University of Colorado – Anschutz Medical Campus.

The Gates Institute and its partners on the CU Anschutz Medical Campus are delivering lifesaving therapies and working to develop more every day. We are only limited by our resources and need you to make our journey a success!

The University of Colorado offers a comprehensive benefits package that includes health insurance, life insurance, retirement plans, tuition benefits, ECO pass, paid time off – vacation, sick, and holidays and more. To see what benefits are available, please visit:

Diversity and Equity:

The University of Colorado Anschutz Medical Campus is committed to recruiting and supporting a diverse student body, faculty and administrative staff. The university strives to promote a culture of inclusiveness, respect, communication and understanding. We encourage applications from women, ethnic minorities, persons with disabilities, persons within the LGBTQ community and all veterans. The University of Colorado is committed to diversity and equality in education and employment.

Qualifications:

Minimum Qualifications:

Associate Director:

• Bachelor’s degree in nursing, healthcare administration, or public health.
  • Substitution: A combination of education and related technical/paraprofessional experience may be substituted for the bachelor’s degree on a year for year basis.
• A registered nurse
• Minimum of 5 years’ experience working in project management and/or clinical operations within the biopharmaceutical industries, a Clinical Research Organization (‘CRO’), and/or academic organization.
• Five years of extensive, diverse and progressively responsible clinical research experience, including direct responsibility for operations and /or organization management, strategic planning, and goal setting.
• Applicants must meet minimum qualifications at the time of hire.

Director:

• Bachelor’s degree in nursing, healthcare administration, or public health.
  • Substitution: A combination of education and related technical/paraprofessional experience may be substituted for the bachelor’s degree on a year for year basis.
• A registered nurse
• Minimum of 6 years’ experience working in project management and/or clinical operations within the biopharmaceutical industries, a Clinical Research Organization (‘CRO’), and/or academic organization.
• Five years of extensive, diverse and progressively responsible clinical research experience, including direct responsibility for operations and /or organization management, strategic planning, and goal setting.

Applicants must meet minimum qualifications at the time of hire.

Preferred Qualifications:

• Master’s Degree in nursing, healthcare administration, or public health.
• Proven track record of successfully managing large-scale, complex Phase I clinical trials.
• Five years of experience working in clinical research at an academic institution.
• Experience providing supervision, mentorship, and training.
• At least two years of experience in Oncology and/or Cell and Gene therapies.
• Certified as a Clinical Research Professional (CCRP).
• (Additional Preferred at Director Level): Experience submitting Investigational New Drug (IND) applications.

Competencies:

• Good knowledge of good clinical practices, clinical trial design, protocol adherence, safety monitoring, study data collection, regulatory processes, and drug development process.
• Strong critical thinking and problem-solving skills required.
• Exceptional communication and interpersonal skills, both oral and written.
• Excellent multi-tasking and organizational skills, as well as the ability to make complex decisions in a fast-paced environment.
• Ability to learn quickly and understand new technical concepts and processes.
• Flexible and able to adapt to program growth and evolving responsibilities.
• Self-motivated and able to work in a team environment.
• Able to work well under pressure, especially when assisting involved stakeholders.
• A strong working knowledge of Good Clinical Practices (GCP), U.S. Food and Drug Administration (FDA) rules and regulations in relation to clinical trials, and other universally accepted practices and procedures within clinician trial management.

How to Apply:

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

Questions should be directed to: Joleen Bohnen, joleen.bohnen@cuanschutz.edu

Screening of Applications Begins:

Immediately and continues until position is filled. For best consideration, apply by June 24 2024.

Anticipated Pay Range:

The starting hiring range for this position has been established as

Associate Director: $109,880 - $140,000

Director: $125,000 - $164,432

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:

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.