DESCRIPTION

The Alzheimer's Disease Cooperative Study (ADCS) consists of 7 cores, 22 committees, 35 research sites that are members of the consortium/Steering Committee, and an additional 40 or more research sites located across the U.S. and Canada that participate in one or more trials coordinated by the ADCS. Annual funding for the ADCS grant is approximately $10 million, with additional funding through industry partnerships. The ADCS provides expertise in developing Alzheimer's disease related protocols and is the coordinating center for multiple clinical trials of varying sizes and complexity under subcontracts funded by NIH and clinical trial agreements with industry.

The Clinical Operations Director oversees the Alzheimer’s Disease Cooperative Study (ADCS) Clinical Operations Group and reports directly to the ADCS Director, Dr. Howard Feldman and administratively to the ADCS Chief of Staff. The Clinical Operations Director works hand-in-hand with the Chief of Staff to ensure the efficient operation of ADCS clinical trials and is responsible for the overall management and success of clinical operations and its team members that support clinical trials in compliance with applicable regulations, ICH-GCP Guidelines, and ADCS SOPs. The incumbent manages the planning and implementation of ADCS trials in collaboration with other ADCS Core Directors, study sponsors, and Project Directors. Responsible for leadership, Clinical Operations staff development, budgeting, and compliance to ensure a robust, service-oriented clinical trials infrastructure. Management duties include oversight of personnel including collaborating with the Chief of Staff to hire, motivate, train, and counsel staff, ensure their professional development, and complete performance evaluations. Effectively manages workload of supervised staff, with continual assessment and adjustment as necessary.

The ADCS coordinates multiple clinical trials of promising agents for the prevention or treatment of Alzheimer's Disease, with up to 10 clinical trials being conducted at any one time at various stages of development, implementation, or close out. The Clinical Operations Director promotes new clinical trials and guides direction with industry and cooperative groups, works collaboratively with outside affiliates, represents the ADCS both internally and externally, and identifies barriers to successful clinical trials execution and fosters approaches toward reducing barriers. The incumbent will coordinate activities among seven ADCS functional groups (Clinical Operations--includes regulatory and QA, Administration--includes recruitment and IT, Biomarkers, Medical Safety and Monitoring, Biostatistics, Data Management and Informatics, and Imaging), the Project Director of each trial, and will build a collaborative team focused on the efficient performance of clinical trials. Responsible for working with the Chief of Staff to ensure clinical trial resources are continuously adequate; participates in the interview and selection of clinical operations personnel. Allocates resources with focus on efficiency, time-lines and project deliverables.

The incumbent is responsible for providing the Chief of Staff information/data to contribute to strategic planning efforts to ensure that Clinical Operations keeps pace with planned ADCS clinical trials. The Clinical Operations Director oversees successful project management, and provides overall supervision, mentorship, and training to project managers, project coordinators, regulatory and QA, as well as other clinical operations staff. Fields and prioritizes queries from ADCS Cores, particularly from the Data Management and Informatics Core, and the Administrative Core, as well as from individual Project Directors. The Clinical Operations Director provides project coordination to clinical operations staff, participates in developing, training, and maintaining Standard Operating Procedures, and assists in grant writing. Responsible for the development and revision of clinical SOPs and department guidelines to ensure adherence to applicable ethical, regulatory, and clinical standards. Provides input to the clinical operations portion of proposals, budgets and contracts. Provides support to the daily conduct of ongoing communication responding to inquiries from clinical sites and project team members; addresses client requests, as applicable. Performs other related director functions as required.

Manages clinical operations, including clinical trial budget development for clinical research initiatives and/or clinical research programs. Receives research objectives and defines subordinate goals in order to achieve those objectives.

MINIMUM QUALIFICATIONS

• Master's degree in related area and / or equivalent experience / training preferred.

• Seven (7+) or more years of relevant experience.

• Broad academic knowledge and applied background in clinical research philosophy. Applies knowledge of theoretical concepts and business best practices in a trial setting. Proven ability to translate clinical research philosophy into direct and indirect clinical input to design, planning, initiation, execution and reporting of clinical trials. Experience in conducting multi-center clinical trials in AD.

• Broad knowledge of clinical research concepts, federal, state and local laws and regulations, and industry requirements regarding the proper conduct of clinical trials. Broad theoretical and operational knowledge of clinical and patient safety standards and regulations relating to clinical research. Advanced knowledge of regulations pertaining to HIPAA and GCP.

• Broad knowledge of all phases of clinical research, from study startup through closeout and primary publication and presentation. Knowledgeable about clinical studies involving complex trial design issues. Experience in Alzheimer's Disease and dementia. Working knowledge of cognitive instruments, particularly the ADAS-Cog, CGIC, ADL, etc.

• Demonstrated management skills supervising, maintaining and developing clinical staff within the study team, and acting as a mentor for professional staff and conducting reviews and performance evaluations. Effectively manages multiple important priorities.

• Ability to work collaboratively with other cross-functional teams and people with a wide range of educational backgrounds. Ability to interface with commercial, regulatory, federal and other members of an extended study team. Ability to influence / persuade. Experience working with NIH/NIA and other federal grant funding agencies. Experience working with site PIs, and study Project Directors.

• Excellent problem-solving and analytical skills. Creatively addresses complex or new problems. Proven skills to quickly evaluate complex issues and identify multiple options for resolution. Advanced experience in project management, including ability to multi-task and re-prioritize deliverables as necessary to meet tight timelines. Demonstrates calm under pressure.

• Strong communicator; includes verbal and written, active listening, critical thinking, persuasiveness, advising and counseling skills. Skill in analyzing and presenting data and strategy to relevant team, governance, external consultant, and regulatory / oversight meetings.

• Expert user of the campus' clinical information and documentation application programs. Technical proficiency in project management software.

SPECIAL CONDITIONS

• Employment is subject to a criminal background check.
• Must be willing to work weekends, holidays, and as generally necessary to meet trial timelines. Occasional travel required.