Clinical Trials Manager

Job Summary:

This position drives scientific planning, strategy, and execution of Phase 1-3 clinical studies. Under the direction of the Executive Director and Medical Director of ClinImmune, the Clinical Trial Manager will collaborate with global, cross-functional team members including clinical directors and study managers to lead/support clinical trial scientific activities.

Key Responsibilities:

• Responsible for drafting the clinical protocol in HLA gene editing.
• Under the direction of the Medical Director, the Clinical Trials Manager serves as the lead clinical scientist on the clinical trial team.
• Accountable for review, analysis, and presentation of clinical trial data for internal decision making, external interactions, and regulatory submission.
• Participates in the set up and design during study start up (e.g., protocol development, IND submission, and database set up).
• Oversees medical monitoring and management of collaborators, consultants, and/or Clinical Research Organizations in completion of key projects.
• Anticipate and actively manage problems across a broad spectrum of cross-functional teams.
• Work cross functionally within teams to ensure clinical strategy is translated into the development of the study concept document, study protocol and related documents.
• Collaborates with the Medical Writer on clinical/scientific and regulatory documents.
• Lead medical monitoring team in review and interpretation of clinical data/medical protocol deviations in collaboration with the Medical Director.
• Builds talent and capabilities of direct/indirect team members through proactive coaching, mentoring and development opportunities.
• May include management of direct reports including assignment of resources, professional development, and performance management.
• May serve as a subject matter expert and/or participate on process improvement teams.

Work Location:

Hybrid - this role is eligible for a hybrid schedule to work remote and on campus as needed for in-person meetings and collaboration.

Why Join Us:

As an academic based biotechnology company, ClinImmune Cell & Gene Therapy is committed to providing the highest quality service and support to clinical customers and researchers locally and abroad. Our prime location at the University of Colorado Anschutz Medical Campus allows for collaboration with world-renowned clinicians and scientists. ClinImmune Cell & Gene Therapy is an academic and clinical component of the University of Colorado Anschutz Medical Campus.

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.

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. In addition, the Anschutz Campus has also been recognized as an Age-Friendly University. The University of Colorado is committed to diversity and equality in education and employment.

Qualifications:

Minimum Qualifications:
Applicants must meet minimum qualifications at the time of hire.

• PhD or PharmD + 6 years clinical trial experience.

Preferred Qualifications:

• Degree in immunology, preferred.
• Strong preference for individuals with proven track record of early phase clinical trial development in industry or academia.

Knowledge, Skills and Abilities:

• Strong communication and presentation skills to clearly communicate scientific concepts /data to leadership committees both internally or externally (both written and oral).
• Experience with designing, monitoring, and implementing clinical trials and interpreting test results in compliance with Good Clinical Practice standards and regulatory requirements.
• Understanding of conducting study data readout activities, including data cleaning, data base lock, data extract, producing outputs of data.
• Experience drafting high level submission documents for regulatory submissions including authoring clinical regulatory responses for health regulatory interactions.
• Serving as a contributing author to scientific publications and data presentations at scientific conferences.

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. Five professional references including name, address, phone number (mobile number if appropriate), and email address

Applications are accepted electronically ONLY at www.cu.edu/cu-careers.

Questions should be directed to: Sandra Fradenburg - sandra.fradenburg@cuanschutz.edu

Screening of Applications Begins:

Immediately and continues until November 26, 2024.

Anticipated Pay Range:

The starting salary range (or hiring range) for this position has been established as HIRING RANGE:

$130,000

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 is not eligible for overtime compensation unless it is non-exempt.

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: http://www.cu.edu/node/153125

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@ucdenver.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.