Description
Kaiser Permanente Northern California (KPNC) seeks a Medical Director for its regional Clinical Trials Program (CTP). This Regional Medical Director position will provide principal oversight for the CTP in KPNC. They will also represent the KPNC region on a national level within KP for clinical trials.
The ideal candidate will be a board-certified physician with a strong background in clinical trials and a vision for advancing patient care through trial-based research. This role would provide approximately 50% FTE support. It is anticipated the balance of the candidate’s time would include investigator-funded research (including as the PI on clinical trials) and specialty-specific clinical duties. The Director will report to The Permanente Medical Group (TPMG) Chief Research Officer (CRO). They will work with other TPMG and KFH clinical leadership to effectively execute a regional clinical trials strategic plan. They would work with the CTP Executive Committee, which includes specialty-specific trialist leads, research pharmacists, clinical trial program leads in other KP regions, and others for advancing trials within KPNC and across KP more broadly. They would work directly with the CTP’s Managing Director, Assistant Medical Director(s), and staff to execute strategic plans and day-to-day operational oversight of all clinical trials within KPNC.
Clinical trials are an essential part of clinical care. KPNC currently conducts more than 150 active clinical trials involving pharmacologic agents, devices, diagnostic tests, lifestyle/behavioral interventions, system-level interventions, and others across multiple specialties. KPNC includes >4.6 million members, sub-regional Clinical Trial Units (CTUs) based at medical centers, and a comprehensive electronic health record across 21 medical centers. Thus, clinical trials in KPNC offer the potential to impact approximately one of every 70 people in the United States. KPNC includes nationally respected trials groups in multiple areas, including adult and pediatric oncology, vaccines, structural heart interventions, cardiology, infectious diseases, dermatology, and more.
Key Responsibilities:
- Program Development and Implementation: Provide overall vision and strategic direction for the CTP in alignment with organizational goals and priorities.
- Physician Engagement: Serve as the clinical champion for trials within the medical group, engaging physicians across specialties to participate in and support clinical trials. Work with physician investigators to cultivate and expand their clinical trials portfolios.
- Culture: Develop a culture of human subjects’ protection and actions aligned with KPNC research objectives to have KPNC research groups be the best places to work. Foster a culture that enables interested TPMG physicians to participate in clinical trials research. Create a culture of innovation in medical care delivery by exploring novel treatment options.
- Collaboration and development: Collaborate with clinical trials leaders from other KP regions to develop an enterprise-wide strategy for clinical trials within Kaiser Permanente (KP). Collaborate with other clinical trial departments (including pharmacy, nursing, and inpatient spaces, for example) to facilitate seamless integration of clinical trials into the care being provided.
- Strategic Partnership and Development: Communicate with external sponsors including pharmaceutical and device companies, research institutions, and academic centers to identify opportunities and foster collaborations.
- Clinical Oversight: Provide medical oversight for active trials including protocol adherence, subject safety, and data integrity across participating sites.
- Accelerate Study Activation & Participant Recruitment: Work with the CTP team, internal collaborators/entities, investigators, and sponsors to accelerate site activation. Support development of reproducible processes, assets, and tools to minimize time to first participant enrolled.
- Site and Staff Development: Collaborate with site managers and research coordinators to ensure readiness, staff training, and quality implementation of trial protocols. Promote support for expansion of appropriately staffed and equipped physical Clinical Trial Units (CTUs) throughout the region.
- Regulatory & Compliance: Assist with the development and implementation of structures, processes and tools to ensure all clinical trials comply with GCP, FDA, ICH, KP and any other relevant regulatory entities’ requirements. Partner with the Human Research Protection Program and Institutional Review Boards to ensure human subject protections for patients enrolling in a clinical trial. Develop and promote collaborative audit and improvement processes.
- Data & Reporting: Develop and implement data collection and analysis for trials-related performance metrics, enhanced digital tools, and data-driven decision making. Review study data and metrics regularly to ensure performance, address challenges, and support publishing key findings.
- Program Growth: Identify new research opportunities, therapeutic areas, and funding mechanisms to expand the clinical research footprint.
- Digital Solutions: Assist in designing the most effective, integrated and scalable CT Digital Ecosystem to support all aspects of clinical trials and compassionate use/expanded access program requests.
- Financial and contract management: Forecast and develop budgetary needs for clinical trials operations. Promote efficient use of resources and identify potential sources for new revenue.
- Patient-Centered Research: Advocate for trial designs and recruitment strategies that reflect the diversity and needs of our patient population.
Qualifications:
- Education: MD or DO required; board certification in a medical specialty.
- Experience:
- Minimum 5–7 years of clinical practice experience.
- At least 3 years of experience in clinical trials, preferably within an integrated health system or medical group setting.
- Prior leadership experience in clinical research or medical administration preferred.
- Skills & Competencies:
- Deep understanding of clinical trial design, execution, and regulatory frameworks.
- Excellent leadership, communication, and collaboration skills.
- Ability to inspire and mentor physicians and clinical trial support staff.
- Strong organizational skills.
- Commitment to health equity and innovation in patient care.
Application & Contact Info
Apply here.
Questions about the position can be sent to Jennifer L. Schneider, Jennifer.L1.Schneider@kp.org.
