AVP - Clinical Research

SUMMARY:

The Associate Vice President (AVP) for Clinical Research provides executive leadership, strategic direction, and operational oversight to support, stabilize, and grow the clinical research programs across TMC Health and affiliated entities. This role is responsible for stabilizing foundational research infrastructure, and guiding the development of an integrated, high‑reliability clinical research enterprise that aligns with organizational strategy, supports physician and investigator engagement, ensures regulatory and ethical compliance, and expands externally funded research.

The AVP oversees research governance, infrastructure, compliance, finance, and performance management, and serves as the senior institutional liaison to regulatory agencies, funding organizations, sponsors, and academic partners. The role includes development and execution of long‑range clinical research strategy, growth of industry‑sponsored and investigator‑initiated studies, and stewardship of resources to ensure sustainability, quality, and national competitiveness.

ESSENTIAL FUNCTIONS

Strategic and Executive Leadership

• Provides enterprise‑wide executive leadership for all clinical research at TMC Health, playing a central role in the development, stabilization, and growth of strategy, priorities, and growth in alignment with TMC Health’s mission, quality goals, and strategic plan.
• Develops and executes a multi‑year clinical research strategic plan, prioritizing infrastructure development, funding diversification, operational sustainability, and investigator support.
• Serves as executive sponsor for key clinical research initiatives, ensuring alignment with clinical, quality, operational, leadership, and actively seeks and cultivates strategic partnerships with collaborators to expand research opportunities and strengthen program capabilities.
• Represents TMC Health externally with sponsors, academic institutions, funding agencies, and regulatory bodies.

Research Governance and Compliance Oversight

• Establishes and oversees research governance structures, policies, and standardized operating procedures.
• Provides executive oversight of external Institutional Review Board (IRB) engagement and human subject protection processes.
• Ensures full compliance with all applicable federal, state, and international regulations, including FDA, HHS / OHRP, NIH, Good Clinical Practice (GCP), and International Council for Harmonization (ICH) standards, in addition to external surveyors such as Joint Commission, the Center for Medicare and Medicaid Services (CMS), and the Accreditation Commission for Health Care (ACHC).
• Certifies institutional compliance to federal, corporate, and private funding agencies.

Operational and Financial Management

• Partners with Clinical Research Directors, Primary Investigators, and Clinical Research staff to assess needs and to develop a strategic plan for standardized operational growth.
• Partners with Clinical Research Directors on research financial performance, including budgeting, forecasting, cost recovery, and contract negotiations.
• Drives operational efficiency, scalability, and standardization across research programs and clinical sites.
• Utilizes dashboards and metrics to evaluate program performance and guide strategic decision‑making.

Research Development and Funding

• Leads institutional strategy for extramural funding, industry partnerships, investigator‑initiated research, and collaborative studies, in close coordination with Research Development, Finance, Clinical Operations, and Compliance.
• Guides development of competitive grant applications and industry trial proposals.
• Builds and sustains relationships with sponsors, CROs, foundations, and government agencies.
• Supports investigators in study design, data analysis, dissemination, and publication of research findings.

Leadership and Talent Development

• Provides executive oversight of Directors, Managers, and staff within the clinical research enterprise.
• Partners with the Clinical Research Directors to Build and sustain a high‑performing, multidisciplinary research workforce through recruitment, coaching, professional development, and performance management.
• Fosters an organizational culture of research grounded in integrity, accountability, collaboration, diversity, and continuous improvement.

Committee and Institutional Engagement

• Serves as executive chair or sponsor for research governance committees (e.g., Research Resource Review Committee / 3RC).
• Presents clinical research metrics and strategic updates to the Medical Executive Committee (MEC), Graduate Medical Education Committee (GMEC), Board‑level committees, and other governance bodies as appropriate.
• Supports Directors to operationalize research with Quality, Compliance, Legal, Finance, and Operations leaders to integrate research safely and efficiently into clinical workflows.

Organizational Standards

• Maintains confidentiality and protects sensitive patient, research, proprietary, and personnel information.
• Adheres to all organizational safety standards, policies, and TMC values.
• Performs related duties as assigned.

MINIMUM QUALIFICATIONS

EDUCATION:

• Master’s degree in clinical research, Public Health, Health Administration, Business Administration, Epidemiology, or related field required.
• Doctoral degree preferred (MD, DO, PhD, PharmD, DrPH, or equivalent terminal degree in a health, biomedical, or scientific discipline).
• Formal education or advanced training in clinical research methods, biostatistics, or translational science preferred.

EXPERIENCE:

• Ten (10) or more years of progressively responsible experience in clinical research, academic medicine, or healthcare research administration.
• Minimum of five (5) years in a senior leadership role (Director‑level or higher) with accountability for enterprise research operations, regulatory compliance, and financial performance.
• Demonstrated experience overseeing a diverse research portfolio, including industry‑sponsored trials, investigator‑initiated studies, and federally or foundation‑funded research.
• Experience integrating research operations into complex health system clinical workflows strongly preferred.

LICENSURE OR CERTIFICATION:

• Good Clinical Practice (GCP) certification required.
• Additional training/certification that demonstrates advanced clinical research operations and/or research administration competency is encouraged.

KNOWLEDGE, SKILLS, AND ABILITIES:

• Current working knowledge of Good Clinical Practice (GCP), International Conference on Harmonization (ICH), federal, Human Subject Research Compliance Oversight Procedures issued by the Office for Protection from Research Risks (OPRR) under the National Institutes of Health (NIH).
• Ability to read, analyze and interpret scientific and technical journals and/or legal documents.
• Ability to respond to sensitive and/or confidential inquiries or complaints from regulatory agencies or members of the community; ability to make effective presentations or write articles and reports for publication that conform to prescribed style and format.
• Ability to effectively present information to senior management, physicians, public groups and/or boards of directors.
• Ability to work with concepts such as fractions, percentages, ratios and proportions, and to apply mathematical operations to solve or analyze job-related situations; ability to create financial forecasts and budgets.
• Ability to identify positive or negative variances from expected outcomes.
• Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems.

• Ability to perform critical thinking and analysis.

• Ability to digest regulatory, industry, and other business guidance, and to communicate and advise necessary actions needed on behalf of the organization.

• Ability to demonstrate effective use of computer software tools to assist in accomplishment of duties. (e.g,. IW/XRS, EDC, Excel, Word, Outlook, PowerPoint)

• Knowledge in research compliance, FDA-regulated research, and huma subject protections.

• Skills with research contracting, budgeting, cost recovery models, and sponsor negotiations.

• Skills in securing and managing external research funding and institutional partnerships.

• Skills in working directly with executive leadership, legal teams, boards, and medical staff governance structures including contracting and negotiations.