Master's degree in Physician Assistant Studies from an accredited program
Current NCCPA certification
Active New York State Physician Assistant license
Minimum of 5 years clinical experience as a PA, with 3 years in hematology/oncology
Experience with oncology clinical trials
Leadership or program management experience
Knowledge of ICH-GCP, FDA regulations, and IRB requirements
Strong clinical judgment and communication skills
Responsibilities
Lead daily operations of the Phase 1 oncology program
Supervise advanced practice providers and research staff
Manage the Phase 1 trial portfolio and feasibility reviews
Oversee study start-up and activation with Regulatory Affairs
Serve as primary operational contact for sponsors and CROs
Develop staffing models and productivity metrics
Coordinate with various teams to maintain trial workflows
Benefits
Comprehensive health insurance
Retirement savings plan
Professional development opportunities
Support for continuing education
Work-life balance with a Monday to Friday schedule
Full Job Description
City/State: Bronx, New York Grant Funded: Yes Department: Cancer Clinical Trials Office - Operations Work Shift: Day Work Days: MON-FRI Scheduled Hours: 9 AM-5 PM Scheduled Daily Hours: 7.5 HOURS Pay Range: $168,000.00-$210,000.00
The Chief Physician Assistant leads the Phase 1 (early phase) oncology clinical trials program at Montefiore Einstein Comprehensive Cancer Center, an NCI-designated comprehensive cancer center. The role combines program leadership with direct care of patients enrolled on first-in-human and early phase trials.
The Chief PA oversees the program's clinical and research operations: advanced practice providers, clinical research staff, the trial portfolio, sponsor and CRO relationships, and quality. The Chief PA works closely with Phase 1 investigators, research nursing, investigational pharmacy, regulatory affairs, and CCTO leadership.
We are looking for an experienced, committed clinician and leader who can grow a high-performing Phase 1 program and expand access to novel therapies for the diverse patient population of the Bronx.
Program leadership and administration
Lead daily operations of the Phase 1 program across clinic, infusion, and research functions to ensure safe, efficient enrollment and treatment of trial participants
Supervise Phase 1 advanced practice providers and research staff (clinical trial managers, research associates), directly or through managers: hiring, onboarding, scheduling, performance evaluations, and professional development
Manage the Phase 1 trial portfolio with the Phase 1 Physician Leader: feasibility review, study selection, prioritization, and capacity planning
Oversee study start-up and activation in partnership with Regulatory Affairs, including site qualification visits and site initiation visits
Manage cohort slot allocation, screening pipelines, and enrollment against sponsor timelines and accrual goals
Serve as the primary operational contact for sponsors and CROs; lead escalation of site performance issues and monitoring findings.
Develop and monitor staffing models, and accrual and productivity metrics; report to CCTO and Cancer Center leadership
Coordinate with investigational pharmacy, research nursing, specimen processing, radiology, and Epic Beacon teams to maintain efficient trial workflows
Lead Phase 1 team meetings and participate in dose escalation safety reviews and CCTO leadership meetings
APP leadership and clinical oversight
Provide clinical leadership and supervision of Phase 1 advanced practice providers (PAs and NPs)
Set clinical standards for eligibility assessment, adverse event assessment and grading (CTCAE), dose-limiting toxicity evaluation, and protocol-required documentation
Develop and implement Phase 1 clinical workflows and pathways, including management of infusion reactions, cytokine release syndrome, and other early phase toxicities
Monitor clinical quality, patient safety events, and protocol compliance; lead corrective and preventive actions
Serve as liaison between APPs, investigators, nursing, pharmacy, and administrative leadership
Clinical responsibilities
Under guidance of a supervising MD, maintain a clinical panel of patients enrolled on early phase trials: review histories, perform physical exams and review of systems, and manage treatment and supportive care
Screen patients for trial eligibility in collaboration with investigators and research staff
Explain study participation to patients and families, including treatment options, alternatives, and expected and unexpected side effects; participate in the informed consent process as delegated by the Principal Investigator
Assess, grade, attribute, and manage adverse events within scope of practice and protocol requirements
Write medical orders for RNs and staff to carry out; ensure protocol-required assessments (labs, PK samples, ECGs, imaging) are ordered and completed in Epic Beacon
Document patient care in the EHR in a timely, protocol-compliant manner that supports source documentation and monitoring
Respond to urgent clinical issues and emergencies in the clinic and treatment areas
Research billing and sponsor invoicing
Accountable for the Epic research billing review for all Phase 1 study activity, ensuring charges route to the study or to insurance per the coverage analysis; performs reviews directly or oversees the clinical trial managers who complete them
Accountable for timely, accurate invoicing of sponsor-billable charges (e.g., procedures, screen failures, pass-through costs) through the CCTO's external invoicing partner, including reconciling invoices against study activity and resolving discrepancies
Monitors billing review timeliness and error trends, and corrects workflows or retrains staff as needed
Quality, compliance and audit readiness
Ensure the program complies with ICH-GCP, FDA regulations (21 CFR Parts 11, 50, 56 and 312), IRB requirements, protocols, and institutional policy
Maintain readiness for sponsor audits, NCI and cooperative group audits, and FDA inspections; lead site responses to monitoring findings and protocol deviations
Ensure research billing practices comply with the Medicare Clinical Trial Policy and institutional billing compliance requirements
Education and program development
Develop and maintain orientation, training, and competency programs for Phase 1 APPs and research staff
Mentor APPs, research staff, and trainees, and support their continuing education
Lead process improvement initiatives to shorten study activation timelines and improve enrollment
Participate in CCTO and Cancer Center initiatives, quality improvement efforts, and scholarly activities
Qualifications
Required
Master's degree in Physician Assistant Studies from an accredited program
Current certification by the National Commission on Certification of Physician Assistants (NCCPA)
Active New York State Physician Assistant license and registration
Minimum of 5 years of clinical experience as a PA, including at least 3 years in hematology/oncology
Experience caring for patients enrolled on oncology clinical trials
Prior leadership, supervisory, or program management experience
Working knowledge of ICH-GCP, FDA regulations, and IRB requirements for human subjects research
Strong clinical judgment, organizational, and communication skills
Current BLS certification; OHS fit test and annual assessment
Preferred
Experience in a dedicated Phase 1 or early phase oncology program, including first-in-human, dose escalation, and PK-intensive studies
Experience with novel therapeutic modalities such as T-cell engagers, antibody-drug conjugates, or cell therapies
Experience with trial feasibility, and sponsor or CRO management
Proficiency with Epic, including Beacon
ACLS certification
SOCRA or ACRP research certification
About Montefiore Medical Center
Montefiore Medical Center is a teaching hospital located in the Bronx, New York. The hospital was founded in 1884 and has since grown to become one of the largest healthcare systems in the state of New York. Montefiore is affiliated with the Albert Einstein College of Medicine and is known for its expertise in areas such as cardiology, neurology, and oncology. The hospital has been recognized for its commitment to patient care and has received numerous awards and accolades. Montefiore is a non-profit organization and is committed to providing care to underserved communities.
