Director of Clinical Research & Advanced Therapeutics

ANNUAL SALARY (DEPENDING ON SKILLS/EXPERIENCE): $150,000.00 - $180,000.00

JOB SUMMARY: The Director of Clinical Research & Advanced therapeutics provides strategic and operational leadership for Epic Care's clinical research program with a dedicated focus on advanced cellular therapies, including CAR-T. This role is responsible for building and overseeing the infrastructure necessary to conduct clinical trials and outpatient CAR-T therapy, ensuring regulatory compliance, financial sustainability, and high-quality patient care. The Director will collaborate with physician leadership, clinical physicians, nurses, research staff, hospital partners, CROs, and pharmaceutical companies to ensure safe, effective, and patient-centered delivery of research and cellular therapy services.

Program Development & Strategy:

• Define and execute Epic Care's research and Advanced Cellular Therapies program strategy in collaboration with executive leadership.
• Align research and cellular therapy goals with Epic Care's clinical priorities and patient care excellence.
• Design and implement a comprehensive roadmap for outpatient clinical trial enrollment and participation in CAR-T therapy.
• Evaluate infrastructure, staffing, and equipment needs for launch and scalability for clinical trials and CAR-T.
• Build relationships with sponsors (e.g., Novartis, Kite, BMS) and CROs to expand trial and therapy opportunities.

Clinical Operations:

• Oversee patient eligibility workflows, referral processes, and clinical assessments for patients on trial.
• Ensure readiness for leukapheresis, infusion, toxicity management, and post-treatment monitoring.
• Develop and manage clinical trial and CAR-T process checklists.
• Implement protocols for CRS and ICANS recognition and escalation for CART.
• Oversee weekly administrative and clinical meetings, including agendas and minutes.

Regulatory & Compliance:

• Establish and maintain contact with Institutional Review Board (IRB) and oversee processes.
• Ensure compliance with GCP, ICH, FDA, FACT, GMP, SQUIPP, and state regulations.
• Maintain audit readiness and quality assurance processes.
• Ensure proper informed consent and caregiver education workflows.
• Support payer contracting documentation and prior authorization readiness.

Partnerships & Coordination:

• Establish formal agreements with hospital partners, leukapheresis centers, storage providers, and pharmaceutical companies.
• Facilitate communication across care teams through EHR interoperability and shared care plans.
• Lead collaboration with emergency departments and ICU teams for adverse event management.

Financial & Revenue Cycle Management:

• Develop, manage, and monitor budgets including accrual targets, costs, and financial reporting.
• Lead contract negotiations with sponsors, payers, and partners (FFS, case rate, SCAs).
• Evaluate financial implications of trial and therapy participation.
• Implement proactive revenue cycle strategies and troubleshoot reimbursement challenges.
• Collaborate with financial counselors and audit specialists to ensure billing accuracy.

Education & Training:

• Lead staff education on clinical trial and cellular therapy mechanisms, toxicity protocols, and documentation standards in collaboration with physician and clinical team champions
• Ensure ongoing competency training for physicians, clinical teams, and support teams.
• Foster a culture of continuous improvement, accountability, and collaboration.

Data & Reporting:

• Establish systems for data collection, reporting, and compliance along with CIBMTR submissions.
• Implement ongoing internal reporting systems to monitor performance and quality metrics.

EDUCATION / TRAINING REQUIREMENTS:

• Bachelor's degree in nursing, healthcare administration, or life sciences required
• Master's degree or higher preferred.
• Specialized training in oncology research or advanced cellular therapy programs preferred.

LICENSES / CERTIFICATIONS / REGISTRATION:

• Certification in clinical research (SoCRA or ACRP) preferred.

EXPERIENCE REQUIREMENTS:

• Minimum 7-10 years in clinical research or oncology program leadership preferred.
• At least 5 years in a management or director-level role preferred.
• Demonstrated experience with oncology clinical trials required.
• Strong financial management and contract negotiation experience required.
• Experience leading multidisciplinary research teams across multiple sites required.
• Direct experience with advanced cellular therapy programs (CAR-T) preferred.
• Proven success in building and sustaining sponsor and CRO partnerships preferred.
• Experience with CIBMTR reporting and regulatory submissions preferred.

SKILLS & COMPETENCIES:

• Deep understanding of CAR-T therapy workflows and safety protocols preferred.
• Strong leadership presence with excellent communication and stakeholder engagement skills required.
• Financial acumen in budgeting, forecasting, and reimbursement strategy preferred.
• Ability to navigate complex regulatory landscapes and accreditation standards required.
• Demonstrated ability to foster collaboration across physicians, clinical staff, and external partners required.

SUPERVISORY RESPONSIBILITIES (IF APPLICABLE):

• Directly supervises the Research and Advanced Cellular Therapy Team, which may include Clinical Research Coordinators, Research Nurses, Data Specialists, and supporting staff.
• Provides leadership, direction, and performance management for research personnel across multiple sites.
• Responsible for recruitment, onboarding, training, and professional development of staff.
• Conducts regular team meetings, ensures accountability, and fosters a collaborative research culture.
• Oversees succession planning and career development to ensure long-term program sustainability.
• Ensures alignment of team operations with Epic Care's clinical, financial, and strategic goals.

Working Conditions: Environment (Office, warehouse, etc.) - Traditional office environment Physical Requirements (Lifting, standing, etc.) - Large percent of time performing computer based work is required. Occasionally lifts and carries items weighing up to 40lbs. (This description is general in nature and is not intended to be an exhaustive list of all responsibilities. Other duties may be assigned as needed to meet company goals.)