- Salary
- $168k – $210k
- Location
- 1695 Eastchester Road, United States of America
- Type
- Full-time
- Department
- Healthcare
- Seniority
- C-Level
- Experience
- 3+ years
- Education
- Master
- Source
- Workday
Description
City/State:
Bronx, New YorkGrant Funded:
YesDepartment:
Cancer Clinical Trials Office - OperationsWork Shift:
DayWork Days:
MON-FRIScheduled Hours:
9 AM-5 PMScheduled Daily Hours:
7.5 HOURSPay Range:
$168,000.00-$210,000.00The 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