Director, Clinical Research Operations and Strategy

JOB SUMMARY: The Director of Clinical Research Operations and Strategy is a senior business and program leadership role responsible for the development, execution and growth of CARTI's clinical research enterprise to serve a diverse and geographically dispersed population, including rural and underserved communities. In co-leadership with the Medical Director of Clinical Research and reporting directly to the Chief Clinical Officer, this position serves as the operational and strategic anchor of the CARTI research pillar — translating scientific opportunities into an executable, financially sustainable, and sponsor-attractive trial portfolio. This role collaborates closely with the executive leadership, including the CFO, physician investigators, and external partners to align research strategy with organizational priorities and ensure scalable, high-quality program performance.

SPECIFIC JOB DUTIES AND RESPONSIBILITIES:

• Develop and manage CARTI's clinical trial portfolio, evaluating studies for scientific alignment, financial viability, and operational feasibility
• Collaborate with executive and clinical leadership to define research strategy, growth priorities, and new program development
• Support expansion into emerging areas, including theranostics, bispecifics, device-based therapies, and precision medicine
• Cultivate and maintain relationships with pharmaceutical sponsors, biotech companies, device manufacturers, and contract research organizations (CROs) to position CARTI as a preferred investigational site
• Lead site qualification and feasibility processes for sponsor-initiated studies
• Serve as the primary operational liaison for external research partnerships
• Oversee day-to-day research program operations including study activation, patient enrollment performance, data quality, and protocol compliance across all active trials
• Partner with investigators to align research opportunities and support investigator-initiated trial development
• Direct the research operations team establishing performance standards, workflows, and capacity planning
• Ensure that all CARTI research-related committees (CSSC, PRMC, Genetic/Genomic, Grant and Publication Committees) operate as a coordinated system aligned with strategic priorities, regulatory requirements and operational efficiency.
• Develop and manage the research program budget, including trial-level financial modeling
• Lead sponsor contract and budget negotiations
• Oversee Medicare Coverage Analysis and ensure compliant billing practices
• Monitor KPI and prepare financial reporting on research program performance for leadership
• Identify and pursue federal, state, and foundation grant opportunities (e.g. NCORP, FDA-funded initiatives, and rural health research initiatives)
• Lead or co-lead grant applications and funding strategies
• Manage grant reporting, compliance, and financial reconciliation
• Ensure compliance with GCP, FDA regulations, IRB requirements, and institutional SOPs across all active studies
• Maintain high standards for data integrity, audit readiness, and regulatory adherence

OTHER JOB REQUIREMENTS: N/A

SUPERVISORY RESPONSIBILITY: Yes

EDUCATION, CERTIFICATION, LICENSURE, REGISTRATION:

• Bachelor's degree in health sciences, life sciences, business, or related field; Master's degree (MPH, MS, MHA, MBA) with clinical/research foundation, preferred
• CCRP (Certified Clinical Research Professional) CCRC, or equivalent certification preferred

EXPERIENCE, KNOWLEDGE, SKILLS and ABILITIES:

• Minimum 7-12 years of progressive clinical research experience including sponsor facing and network level operations
• Demonstrated success in building, scaling and managing a clinical trial portfolio, including sponsor-facing business development or site selection participation
• Strong working knowledge of GCP, FDA regulatory framework, IRB processes, and Medicare Coverage Analysis
• Experience with clinical trial budget development and sponsor contract negotiation
• Strong communication and relationship management skills; ability to engage credibly with sponsors, physician investigators, executive leadership, and external funders
• Experience with NCI NCORP, NIH grant mechanisms, or state health department research funding, preferred
• Oncology-specific research background, preferred
• Familiarity with device/IDE trial regulations, particularly in emerging therapeutic areas, preferred
• Experience operating in a community-based or rural health care setting, preferred

REASONING ABILITY:

• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
• Ability to interpret a variety of instructions furnished in written, oral, or schedule form.

INTERPERSONAL SKILLS:

• Must interact and communicate both verbally and in written form.
• Must interact and exchange information regarding patients with physicians and other departmental personnel, and outside agencies on a frequent basis while respecting the confidentiality of patient information.

PHYSICAL DEMANDS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• While performing the duties of this job, the employee is regularly required to talk or hear.
• The employee regularly is required to stand, walk, sit, use hand to finger, handle or feel objects, tools, or controls; and reach with hands and arms.
• Specific vision abilities required by this job include close vision and the ability to adjust focus.

WORK ENVIRONMENT:

The work environment described here are representative of those an employee encounters while performing the essential functions of this job. This position involves potential exposure to infectious diseases. Team members are offered appropriate vaccinations and safety training.

This position is a Safety Sensitive Position. The essential functions, physical demands, and mental competencies of this job require the employee maintain the ability to work in a constant state of alertness in a safe manner.