Director of Clinical Research

Boys Town; Omaha (NE); On-site; USD 120,000 - 180,000; Full time

Job summary

Boys Town National Research Hospital is seeking a senior leader to oversee clinical trials research programs and initiatives. This role drives strategy, planning, and execution across trials, ensuring regulatory compliance and data integrity.

The position leads a multidisciplinary team, coordinates with medical professionals and regulatory affairs, and reports progress to senior management, aiming to advance Boys Town's research objectives and patient care outcomes.

Qualifications

• Advanced degree in medical sciences or life sciences required.
• Minimum eight years of clinical research experience with leadership roles.
• CITI certification within 30 days of hire required.

Responsibilities

• Develops and implements the clinical research strategy and operating plans.
• Leads and mentors a team of clinical research professionals.
• Oversees trial design, protocol development, and regulatory compliance.
• Manages submissions to FDA and other regulatory authorities.
• Collaborates with investigators to select trial sites and investigators.
• Maintains internal monitoring for data management and risk review.
• Ensures adverse event reporting aligns with guidelines and data integrity.
• Oversees SOPs to ensure quality and safety of participants.

Skills

Leadership

Strategic planning

Regulatory affairs

Cross-functional collaboration

Budget management

Communication

Education

Advanced degree (Ph.D./Pharm.D./MD/RN)

Tools

Clinical trial management systems (CTMS)

EDC / data management tools

Job description

Leads and manages the clinical trials research programs and initiatives at Boys Town National Research Hospital. Oversees the planning, execution, and reporting of clinical trials and studies to ensure compliance with regulatory guidelines and industry standards. Collaborates with cross-functional teams, including medical professionals, scientists, regulatory affairs, and data management, to drive successful clinical research projects.

MAJOR RESPONSIBILITIES & DUTIES:

• Develops and implements the clinical research strategy and operational plans aligned with the organization's goals and objectives.
• Leads and mentors a team of clinical research professionals, including clinical research associates, coordinators, and project managers.
• Manages the design and protocol development of clinical trials, ensuring adherence to ethical principles, safety guidelines, and regulatory requirements.
• Oversees the preparation and submission of clinical trial applications to regulatory authorities, such as the FDA and/or other relevant bodies.
• Collaborates with medical experts and investigators to identify and select suitable clinical trial sites and investigators.
• Develops and facilitates an internal monitoring program to review data management, identify risks, reduce potential for risk to Boys Town, the research department and research subjects.
• Maintains reporting standards for adverse events in accordance with regulatory and industry guidelines and compliance.
• Reviews and develops department operating procedures to ensure quality implementation of research protocols, ensure the integrity of the data and the safety of research subjects.
• Implements correction action as needed to meet research outcomes for trials. Prepares and presents regular updates and reports on clinical research progress to senior management and stakeholders.
• Collaborates with the biostatistics team to perform statistical analysis of trial data and support the interpretation of study results.
• Collaborates with the medical writing team to prepare clinical study reports, publications, and other regulatory documentation as needed.
• Stays informed about advancements in clinical research methodologies, technology, and regulations to enhance the organization's research capabilities.
• Manages the clinical research budget, resource allocation, and vendor selection as applicable.

KNOWLEDGE, SKILLS, AND ABILITIES:

• Proven leadership skills with the ability to effectively manage and motivate a team.
• Excellent communication and interpersonal skills to collaborate with internal and external stakeholders effectively.
• Strong problem-solving and decision-making abilities to address complex clinical research issues.
• Detail-oriented and organized to ensure compliance and data integrity.
• Ability to handle multiple projects simultaneously and prioritize tasks accordingly.
• Proficiency in relevant software applications and clinical trial management systems.

REQUIRED QUALIFICATIONS:

• Advanced degree (Ph.D., Pharm.D., M.D., or R.N.) in a medical sciences or life sciences-related field required.
• Minimum eight years of experience in clinical research, including significant experience in clinical trial management and leadership roles required.
• Thorough understanding of the drug development process and clinical trial phases (Phase I-IV) required.
• Collaborative Institutional Training Initiative (CITI) certification within 30 days of transfer or hire required.
• Other Duties: This job description incorporates the essential functions and duties required for this position. However, other duties may be required and assigned at times and as determined by a supervisor in order to meet the needs of the organization.
• Serves as a role model in carrying out activities and behaviors that reflect the values and principles of the Boys Town mission.

PHYSICAL REQUIREMENTS, EQUIPMENT USAGE, WORK ENVIRONMENT:

• Position is relatively sedentary in a normal office administrative environment involving minimum exposure to physical risks. Will use office equipment such as a computer/laptop, monitor, keyboard, and a general workstation set-up.

Care and respect for others is more than a commitment at Boys Town - it is the foundation of who we are and what we do.

At Boys Town, we cultivate a culture of belonging for all employees that respects their individual strengths, views, and experiences. We believe that our differences enable us to be a better team - one that makes better decisions, drives innovation, and delivers better business results.

About Boys Town:

Boys Town has been changing the way America cares for children and families since 1917. With over a century of service, our employees have helped us grow from a small boardinghouse in downtown Omaha, Nebraska, into one of the largest national child and family care organizations in the country. With the addition of Boys Town National Research Hospital in 1977, our services branched out into the health care and research fields, offering even more career opportunities to those looking to make a real difference.

Our employees are our #1 supporters when it comes to achieving Boys Town's mission, which is why we are proud of their commitment to making the world a better place for children, families, patients, and communities. A unique feature for employees and their dependents enrolled in medical benefits are reduced to no cost visits for services performed by a Boys Town provider at a Boys Town location. Additional costs savings for the employee and their dependents are found in our pharmacy benefits with low to zero-dollar co-pays on certain maintenance drugs. Boys Town takes your mental health seriously with no cost mental health visits to an in-network provider. We help our employees prepare for retirement with a generous match on their 401K or 401K Roth account. Additional benefits include tuition reimbursement, parenting resources from our experts and professional development opportunities within the organization, just to name a few. Working at Boys Town is more than just a job, it is a way of life.

Boys Town is an equal employment opportunity employer and participates in the E-Verify program. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity and/or expression, national origin, age, disability, or veteran status. To request a disability-related accommodation in the application process, contact us at 1-877-639-6003.