Director of Clinical Research (68742)

United Digestive; Atlanta (GA); Presencial; USD 150.000 - 210.000; Jornada completa

Descripción de la vacante

United Digestive seeks a strategic leader to head the enterprise clinical research program in Atlanta. You will drive growth, partnerships, and financial performance while maintaining compliance with FDA, ICH-GCP, and HIPAA standards.

Ideal candidates have extensive multi-site operations experience and a track record of building scalable research infrastructure. This role includes leading a team and engaging with sponsors, CROs, and academic partners.

Formación

• Bachelor's degree required in a health/science/related field.
• 7+ years of progressive clinical research operations with multi-site leadership.
• Experience with sponsor/CRO partnerships, study portfolio strategy, budgets, contracts, and financial management.
• Knowledge of FDA regulations, ICH-GCP, HIPAA, and quality systems; strong leadership and negotiation skills.

Responsabilidades

• Supervise and lead Clinical Research Manager and centralized research operations staff.
• Develop and execute enterprise clinical research strategy, goals, and growth plan.
• Build partnerships with sponsors, CROs, academics, and healthcare organizations.
• Evaluate and prioritize the study portfolio for strategic fit, feasibility, capacity, and financial viability.
• Own departmental financial performance including budgets, forecasts, contracts, and terms.
• Oversee standardized multi-site research operations, resources, and performance improvement.
• Communicate barriers, and trends to executive leadership.
• Maintain Quality Management System, SOPs, CAPA plans, audits, and FDA readiness.
• Ensure compliance with FDA, ICH-GCP, HIPAA, and sponsor requirements.
• Set roadmap for research technology and data governance.
• Recruit and develop investigators and staff while promoting accountability.

Conocimientos

Strategic leadership

Financial management

Communication

People leadership

Relationship building

Educación

Bachelor's degree in healthcare administration, business administration, life sciences, nursing, public health, or related field

Master's or doctoral degree in healthcare administration, business, public health, regulatory affairs, or related field

Descripción del empleo

Job Location: AGA - Peachtree Dunwoody - Atlanta, GA 30342

Position Type: Full Time

Education Level: 4 Year Degree

Travel Percentage: As needed for business requirements.

Job Category: Ancillary Services

GENERAL SUMMARY OF DUTIES: Provides strategic and operational leadership for United Digestive's enterprise clinical research program, with accountability for growth, partnerships, financial performance, quality, compliance, infrastructure, and talent.

Exceptional candidates with experience beyond the posted level are encouraged to apply. Based on qualifications, experience, and organizational needs, consideration may be given to placement at a higher level.

RESPONSIBILITIES

• Supervise and provide leadership to Clinical Research Manager and centralized research operations staff
• Develop and execute United Digestive's enterprise clinical research strategy, goals, growth plan, and scalable infrastructure
• Build sponsor, CRO, academic, and healthcare partnerships that expand study opportunities, investigator participation, and program reach
• Evaluate and prioritize the study portfolio based on strategic fit, feasibility, capacity, patient population, and financial viability
• Own departmental financial performance, including budgets, forecasts, sponsor budgets, contracts, and key business terms
• Oversee standardized multi-site research operations, resource allocation, systems, and performance improvement
• Remove barriers and communicate operational, financial, enrollment, startup, and quality trends to executive leadership
• Maintain oversight of the Quality Management System, SOPs, CAPA plans, audits, and FDA inspection readiness
• Ensure compliance with FDA regulations, ICH-GCP, HIPAA, institutional policies, and sponsor requirements
• Set the roadmap for research technology, data governance, and standardized tools that support efficient, reliable operations
• Recruit and develop investigators, leaders, and research staff while fostering accountability and continuous improvement

EDUCATION, SKILLS, & EXPERIENCE

Required:

• Bachelor's degree in healthcare administration, business administration, life sciences, nursing, public health, or a related field
• At least seven years of progressive clinical research operations experience, including multi-site program leadership and direct staff management
• Experience with sponsor/CRO partnerships, study portfolio strategy, budgets, contracts, and departmental financial management
• Knowledge of FDA regulations, ICH-GCP, HIPAA, and quality systems, with strong strategic, communication, negotiation, and people-leadership skills

Preferred:

• Master's or doctoral degree in healthcare administration, business, public health, regulatory affairs, or a related field
• Clinical research certification and experience with enterprise research technologies

WORK ENVIRONMENT

Requires sitting and standing associated with a normal office environment. Travel required as business needs dictate.

DRUG FREE WORKPLACE

United Digestive is a drug-free workplace. All offers of employment are contingent upon passing a pre-employment drug screening.

EQUAL OPPORTUNITY EMPLOYER

United Digestive is an equal opportunity employer and will not tolerate discrimination in employment on the basis of race, color, age, sex, sexual orientation, gender identity or expression, religion, disability, ethnicity, national origin, marital status, veteran status, genetic information or any other legally protected classification or status.

Qualifications