Director Clinical Research (Hybrid)

Location Address:
9521 San Mateo NEAlbuquerque, NM 87113-2237

Summary:
The Director of Clinical Research is the senior executive responsible for the strategic, operational, and regulatory leadership of the Presbyterian Healthcare Services clinical research enterprise. Reporting to the delivery system Chief Medical Officer (CMO), this position provides executive oversight for all clinical research activities across the organization and serves as the subject matter expert for clinical research.

The Director provides strategic leadership by ensuring alignment of research activities with Presbyterian Healthcare Services' mission, vision, strategic priorities, and organizational initiatives. The Director is responsible for the ongoing evaluation, development, monitoring, and continuous improvement of research operations and regulatory processes while ensuring compliance with federal and state regulations governing human subjects research, protection of research participants, and adherence to the highest ethical and quality standards.

The Director develops and sustains the infrastructure necessary to support a growing enterprise clinical research program and provides executive oversight of research administration, the Human Research Protection Program (HRPP), the Human Research Protections Office (HRPO), research compliance, financial stewardship, operational performance, and strategic partnerships that expand access to innovative clinical research across Presbyterian Healthcare Services.
• Hybrid: For individuals within 60 miles of Albuquerque, in-office presence is required Tuesday through Thursday.

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Organizational Relationships

Reports To: delivery system Chief Medical Officer (CMO)

Direct Reports: HRPO Manager; Research Operations Managers/Supervisors (as applicable); Clinical Research Coordinators and research personnel (as applicable)

Key Internal Relationships: CEO, Executive Leadership Team, PCLT, Medical Group Leadership, Hospital Leadership, Clinical Program Leadership, Finance, Legal, Compliance, Revenue Cycle, Pharmacy, Quality, Information Services, Population Health, Physician Investigators, Research Staff

Key External Relationships: External IRBs (including WCG), Research Sponsors, CROs, Academic Institutions, Federal and State Regulatory Agencies, Industry Partners, Professional Research Organizations

Authority and Accountability

Accountable for the strategic direction, operational performance, regulatory compliance, financial stewardship, quality, and continuous improvement of the enterprise clinical research program.

Establish enterprise research governance, policies, SOPs, and operational standards.

In partnership with the CMO, develop and execute the enterprise clinical research strategy.

Allocate personnel, financial, technology, and operational resources.

Provide executive oversight of the HRPP and HRPO.

Direct research administration, quality assurance, compliance monitoring, education, and continuous process improvement.

Recommend investments in research infrastructure, staffing, technology, and strategic initiatives.

Identify and escalate significant regulatory, financial, operational, legal, and reputational risks to the CMO and executive leadership.

Represent Presbyterian in collaborations with sponsors, academic institutions, regulatory agencies, industry partners, and professional organizations.

Strategic Leadership

In partnership with the CMO and executive leadership, develop and execute the enterprise clinical research strategy.

Develop infrastructure supporting sustainable research growth.

Expand industry-sponsored, investigator-initiated, federally funded, and collaborative research.

Promote innovation through emerging technologies and AI.

Represent Presbyterian in external collaborations.

Advise the CMO on research priorities, performance, and enterprise risks.

Research Governance

Provide leadership and administrative support for the PCLT Research Subcommittee and research governance committees.

Develop governance processes supporting prioritization, oversight, accountability, and enterprise decision-making.

Present regular reports to executive leadership regarding research performance, compliance, finances, strategic initiatives, and risks.

Research Administration

Direct research administration, research operations, HRPP/HRPO, regulatory affairs, education, quality, infrastructure, and process improvement.

Develop standardized enterprise policies, SOPs, workflows, and quality systems.

Ensure all required approvals before study activation.

Collaborate across departments to remove barriers and improve research infrastructure.

Human Research Protection Program (HRPP)

Provide executive oversight of the HRPP and HRPO.

Supervise the HRPO Manager responsible for determinations, reliance agreements, post-approval monitoring, policy development, education, and regulatory compliance.

Ensure compliance with FDA, OHRP, HIPAA, GCP, sponsor, and institutional requirements.

Oversee enterprise compliance, monitoring, auditing, corrective actions, and accreditation readiness.

Research Portfolio Management

Manage the research portfolio to align with organizational priorities and financial sustainability.

Expand the research portfolio through partnerships and investigator development.

Promote equitable access and diversity in research participation.

Research Finance and Business Operations

Lead budgeting, contracts, billing compliance, resource allocation, and financial sustainability.

Manage departmental operating and capital budgets.

Collaborate with Finance, Legal, Compliance, Contracting, and Revenue Cycle.

Regulatory Compliance and Risk Management

Ensure compliance with applicable regulations and policies.

Identify and mitigate operational, regulatory, financial, legal, and reputational risks.

Serve as liaison with regulatory agencies, sponsors, auditors, and external IRBs.

Research Operations

Lead enterprise research staff.

Recruit, mentor, and retain research professionals.

Oversee study conduct, participant protections, monitoring, adverse event reporting, and research technology.

Investigator Development and Education

Develop physician investigators through mentorship and infrastructure.

Provide education and training for investigators and research staff.

Performance Improvement

Establish enterprise metrics including study activation, enrollment, compliance, financial performance, investigator satisfaction, sponsor satisfaction, and operational efficiency.

Lead continuous quality improvement.

Enterprise Collaboration

Partner with operational, clinical, and administrative leaders to advance research initiatives and organizational priorities.

Additional :

Skills

In-depth knowledge of GCP, FDA, OHRP, HIPAA, HRPP/HRPO, IRB reliance, strategic planning, finance, organizational leadership, communication, and change management.

Education

Master's degree required; doctoral degree (MD, DO, PhD, PharmD, DNP) preferred.

Experience

Minimum 8 years progressive research leadership and 5 years management in integrated healthcare research.

Preferred Certifications

CIP, CCRP, CCRC, CRA, CHRC, CHC.

Benefits
Benefits are effective day-one (for .45 FTE and above) and include:

• Competitive salaries
• Full medical, dental and vision insurance
• Flexible spending accounts (FSAs)
• Free wellness programs
• Paid time off (PTO)
• Retirement plans, including matching employer contributions
• Continuing education and career development opportunities
• Life insurance and short/long term disability programs

About Us
Presbyterian Healthcare Services is a locally owned, not-for-profit healthcare system of nine hospitals, a statewide health plan and a growing multi-specialty medical group. Founded in New Mexico in 1908, it is the state's largest private employer with approximately 11,000 employees.

Presbyterian's story is really the story of the remarkable people who have chosen to work here. Starting with Reverend Cooper who began our journey in 1908, the hard work of thousands of physicians, employees, board members, and other volunteers brought Presbyterian from a tiny tuberculosis sanatorium to a statewide healthcare system, serving more than 700,000 New Mexicans.

We are part of New Mexico's history - and committed to its future. That is why we will continue to work just as hard and care just as deeply to serve New Mexico for years to come.

About New Mexico
New Mexico's unique blend of Spanish, Mexican and Native American influences contribute to a culturally rich lifestyle. Add in Albuquerque's International Balloon Fiesta, Los Alamos' nuclear scientists, Roswell's visitors from outer space, and Santa Fe's artists, and you get an eclectic mix of people, places and experiences that make this state great.

Cities in New Mexico are continually ranked among the nation's best places to work and live by Forbes magazine, Kiplinger's Personal Finance, and other corporate and government relocation managers like Worldwide ERC.

New Mexico offers endless recreational opportunities to explore, and enjoy an active lifestyle. Venture off the beaten path, challenge your body in the elements, or open yourself up to the expansive sky. From hiking, golfing and biking to skiing, snowboarding and boating, it's all available among our beautiful wonders of the west.

AA/EOE/VET/DISABLED. PHS is a drug-free and tobacco-free employer with smoke free campuses.