Administrative Director, Protocol Research - Immunology

The Immunology department at MD Anderson Cancer Center seeks to determine the fundamental cellular and molecular mechanisms of a wide range of processes by which the body recognizes and eliminates pathogens and use these findings to unleash the patient's own immune system against previously treatment-resistant cancers. Treating the immune system rather than the cancer itself, the therapeutics developed are applicable to many cancers.

Immunology

KEY FUNCTIONS

Research Planning, Oversight and Management

• Manages large-scale and multiple site research activities including protocol development, regulatory compliance, protocol/project prioritization, budget, and feasibility
• Develops and manages the implementation of systems, policies, and procedures affecting the development, review, approval, and tracking of PA13-0291 and associated protocols; contract development, facilitation, and execution; and budget creation and reconciliation, according to internal and external requirements
• Provides research development strategies and long-term strategic planning of research initiatives, including funding sources, feasibility, and prioritization
• Supports Immunotherapy Platform (IMT) collaborations within MDACC and with external entities by ensuring project milestones are met and providing timely updates and reports to IMT alliance managers regarding budgets, contracts, protocols, and compliance matters
• Collaborates with management team for writing of research policies/processes and implementation of quality assurance initiatives
• Coordinates strategies to enhance collaborations between investigators and clinical or research scientists/staff
• Prepares and presents progress reports and metrics
• Assists in the regulatory audit process
• Assists with coordination of the Immunotherapy Platform Working Group and Executive Committee meetings and oversight of project selection, review of decisions, tracking, and reporting
• Maintains a high level of professional expertise through educational programs.
• Maintains working knowledge of current Code of Federal Regulation (CFR) and Good Clinical Practice (GCP) guidelines as well as a comprehensive understanding of the research trial processes.
• In collaboration with members of the management team, ensures that the research conducted by the platform meets IRB, federal and/or other guidelines and policies

Research Accounting, Contracts, Protocol and Regulatory Management

• Supervises research activities across collaborating departments, relating to protocol and regulatory compliance, specimen management, and research charge capture and reconciliation
• Composes and updates budgets for IMT-related projects and alliances
• Tracking and reconciliation of IMT funding/accounts
• Identifies appropriate funding sources for staff salaries/effort and IMT expenses.
• Identifies deficits and moves expenses as needed.
• Ensures routine account review with IMT leadership to provide updates on funds and contract information.
• Reviews all IMT agreements for feasibility, compliance with IMT guidelines, and fiscal sustainability
• Updates IMT protocol language, as needed
• Assists PIs with writing of investigator initiated protocols and multicenter language, as needed for IMT alliance projects
• Provides oversight of personnel responsible for troubleshooting, negotiations, and amendments to research plans and agreements, conforming to Food and Drug Administration (FDA), Institutional, and Departmental guidelines as well as Good Clinical Practices (GCP) and protection of principal investigator and research staff

Administration and Management

• Hires, supervises, trains, and mentors regulatory and research compliance personnel and research finance personnel
• Assures policies/procedures of the institution and department are communicated to staff formally and informally
• Evaluates performance of staff, maintains documentation, and manages disciplinary action as needed. Meets on a weekly or biweekly schedule with direct reports.

• Demonstrates excellent and professional oral and written communication skills when contacting other IMT personnel, MDACC investigators, and external collaborators.
• Assimilates pertinent information in order to compose written correspondence
• Coordinates educational activities/opportunities for IMT personnel
• Attends and contributes to routine management meetings. Represents the management team at departmental and institutional meetings and functions, as required

Education

Required: Bachelor's degree in Science, Healthcare, Nursing or related field.

Preferred: Master's degree in Science, Healthcare, Nursing or related field.

Experience

Required: Seven years of extensive research administrative experience in a biotechnology or academic setting to include three years experience with research protocols, grants and contracts and three years supervisory/management experience. With preferred degree, five years of required experience to include three years experience with research protocols, grants and contracts and three years supervisory/management experience. Successful completion of the LEADing Self Accelerate program may substitute for one year of required supervisory or management experience.

Preferred: Budget/contract experience with MD Anderson.

Must pass pre-employment skills test as required and administered by Human Resources

It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. http://www.mdanderson.org/about-us/legal-and-policy/legal-statements/eeo-affirmative-action.html