Chief Physician Assistant

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 ChiefPA oversees the program's clinical and research operations: advanced practice providers, clinical research staff, the trial portfolio, sponsor and CRO relationships, and quality. The ChiefPA 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

Montefiore Medical Center is an equal employment opportunity employer. Montefiore Medical Center will recruit, hire, train, transfer, promote, layoff and discharge associates in all job classifications without regard to their race, color, religion, creed, national origin, alienage or citizenship status, age, gender, actual or presumed disability, history of disability, sexual orientation, gender identity, gender expression, genetic predisposition or carrier status, pregnancy, military status, marital status, or partnership status, or any other characteristic protected by law.