Director of Clinical Research

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:Duties include but are not limited to:Supervise and provide leadership to Clinical Research Manager and centralized research operations staffDevelop and execute United Digestive's enterprise clinical research strategy, goals, growth plan, and scalable infrastructureBuild sponsor, CRO, academic, and healthcare partnerships that expand study opportunities, investigator participation, and program reachEvaluate and prioritize the study portfolio based on strategic fit, feasibility, capacity, patient population, and financial viabilityOwn departmental financial performance, including budgets, forecasts, sponsor budgets, contracts, and key business termsOversee standardized multi-site research operations, resource allocation, systems, and performance improvementRemove barriers and communicate operational, financial, enrollment, startup, and quality trends to executive leadershipMaintain oversight of the Quality Management System, SOPs, CAPA plans, audits, and FDA inspection readinessEnsure compliance with FDA regulations, ICH-GCP, HIPAA, institutional policies, and sponsor requirementsSet the roadmap for research technology, data governance, and standardized tools that support efficient, reliable operationsRecruit and develop investigators, leaders, and research staff while fostering accountability and continuous improvementEDUCATION, SKILLS, & EXPERIENCE:Required:Bachelor's degree in healthcare administration, business administration, life sciences, nursing, public health, or a related fieldAt least seven years of progressive clinical research operations experience, including multi-site program leadership and direct staff managementExperience with sponsor/CRO partnerships, study portfolio strategy, budgets, contracts, and departmental financial managementKnowledge of FDA regulations, ICH-GCP, HIPAA, and quality systems, with strong strategic, communication, negotiation, and people-leadership skillsPreferred:Master's or doctoral degree in healthcare administration, business, public health, regulatory affairs, or a related fieldClinical research certification and experience with enterprise research technologiesWORK 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.
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