Washington University is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, genetic information, disability, or protected veteran status.
This position is full-time and works approximately 40 hours per week.
Department Name/Job Location:
This position is in the Department of Neurology, Division of Aging and Dementia in the DIAN-TU Lab. This position is for the Medical School Campus.
Position directs daily activities for grants, contracts, funding, and proposal submissions for the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU). The position requires an individual with exceptional analytic, writing, organizational, project management and communication skills.
PRIMARY DUTIES AND RESPONSIBILITIES:
Holds responsibility for day-to-day activities including fiscal and administrative management, contracts and funds, and multicomponent grants and subcontracts.
Coordinate research to design the most effective and efficient trials for dominantly inherited AD (DIAD). Designs, implements, and manages all phases of pre-competitive trial design requiring coordination of expertise from all trial stakeholders (academics, pharma, regulators, NIA, philanthropic funders, patient advocacy groups, and DIAD individuals and families) for initial brainstorming, design vetting and full development of design proposal. Identify new program and collaboration opportunities, and prepare funding proposals for trial design research and implementation of clinical trials in DIAD including multi-component and multi-site grants and contracts. Serves as liaison with funding or sponsoring agency. Track, evaluate, and report progress of projects supporting trial design. Collaborates with other investigators within and external to the university to develop research studies.
Organize and participate in regular international meetings (multiple meetings per year) to coordinate expertise for precompetitive trial design (Pharma, regulators, consultants, researchers, patients, funding agencies, etc.) including development of agendas, coordination of presentation and speakers, assignment and tracking of action items, communications with meeting attendees, distribution of meeting materials.
Manage the DIAN-TU Pharma Consortium.
Primary contact for companies interested in joining the Pharma Consortium.
Manages data requests for analyses of DIAN Observational study data to inform on clinical trial design.
Ancillary study management and oversight.
Manage finances for the DIAN-TU Pharma Consortium activities.
Generate and distribute progress reports to the Pharma Consortium members.
Organize and plan working group meetings (Trial Design, Biomarkers and Cognitive Endpoint) to vet critical issues related to trial design for DIAD.
Manage the nomination and evaluation process for potential drugs for use in DIAN-TU Clinical Trials.
Develop and maintain forms and procedures including standard operating procedures, Conflict of Interest (COI) management, nomination and evaluation forms, evaluation process, etc.
Identification and invitation of Therapy Evaluation Committee members – ensure committee has appropriate expertise specific to compounds under review.
Execution of CDAs.
Coordination of Therapy Evaluation Meetings (agenda, minutes, action item tracking, communicating feedback to Pharma companies, COI management).
Manage completed nomination packets including maintenance of confidentiality of documents and of nominating companies.
Obtaining drug nomination updated information from companies and communicating to Therapy Evaluation Committee members.
Primary contact for nominating companies and therapy evaluation activities.
Organize and participate in regular meetings with the company sponsors, consultants and other personnel involved with the projects to track status, ensure issues are addressed and resolved and ensure project goals are met.
Responsible for the development of forms, questionnaires, policies, procedures, and governance for major research committees and leadership structures, etc.
Therapy evaluation: Develop and maintain forms and procedures including standard operating procedures, Conflict of Interest (COI) management, nomination and evaluation forms, evaluation process, etc.
Trial data sharing:
Develop and implement system and process for sharing baseline and post randomization trial data.
Coordinate data request review and approval.
Track data transfer and follow-up on data analysis.
Ensure communication of data analysis results (publications, presentations, etc.) per study requirements.
Development and enforcement of public communication policies and procedures.
Review of media releases and public presentations.
Communication of media announcements to all stakeholders.
Trial-specific policies and procedures.
Assures adherence to grant, IRB, and Washington University accounting guidelines for associated grants. Assist DIAN-TU Leadership with regulatory compliance including writing instructional procedure manuals related to trial design and trial implementation activities.
Assist with development and maintenance of Standard Operating Procedures (SOPs).
Participate in quality, operational and financial audits including preparation, presenting/speaking to auditors, and addressing audit findings.
Conflict of interest disclosure and management as related to the DIAN and DIAN-TU projects and for Dr. Randall J. Bateman.
Work with WU, pharma, and funding agency media public relations and legal groups to develop and manage press releases and other public communications regarding the trial and other DIAN-TU projects (presentations, interviews, announcements, etc.)
Work with DIAN-TU leadership and Clinical Operations to ensure trial compliance and address issues.
Advises directors on matters of scientific and fiscal concerns.
Primary liaison to PI in developing plans for research projects and discussing the interpretation of results; serves as liaison with funding or sponsoring agency. Collaborates with other investigators within the university to develop research studies.
Project management of DIAN-TU per-competitive trial design and supportive studies.
Development and tracking of timelines.
Coordination with other projects.
Prioritization of activities.
Coordinate preclinical studies related to DIAN-TU clinical trials to guide trial design.
Receive or develop study proposals.
Distribute to appropriate stakeholders for review.
Distribute and track funding.
Track and report progress.
Reviews journals, abstracts, and scientific literature to keep abreast of new developments and to obtain information regarding previous studies to aid in the planning of new studies.
Composes annual solicitation of pilot proposals and project reviews. Assists in the preparation of grant proposals and/or modifications to study design as appropriate.
Draft funding proposals.
Prepare all supportive documents and assist with specific aims and research strategy.
Ensure completion of documents and application submission.
Communicate with and create proposals for non-federal funding agencies (foundations, philanthropy).
Provides projections/recommendations for future resource allocations and scientific directors.
Supervises support staff and advises senior faculty in personnel management. Provides guidance to members of research team in the implementation and evaluation of clinical trial research; trains new staff; may serve as lead or as point of reference for other research coordinators.
Manages administration of shared space, equipment, and furnishings of offices.
Prepares and maintains minutes from Executive Committee meetings, formal voting procedures, and committee activity related to proposals, ensuring follow up on decisions made.
Provides planning and coordination of meetings and schedules presentations for team training.
Establishes/enhances community and donor contacts’, and contact with other centers to facilitate collaboration and exchange of information. Write and negotiate contracts (in concert with appropriate university offices, e.g. MTAs, performance site subcontracts) to ensure research goals:
Pharma collaborator contracts.
Trial vendor contracts.
Consultant agreements for trial design.
CDAs for new pharma collaborators, therapy evaluation committee members, pharma consortium members, vendors, consultants and other collaborators as needed.
Pharma Consortium term agreements.
Participates in project review meetings and report preparation and analysis. Evaluates and interprets collected clinical data in conjunction with PI as appropriate; prepares oral and written presentations or reports and analyses setting forth progress trends and provides recommendations or conclusions of the same. Collaborates in the preparation of manuscripts for publication.
Prepares and maintains DIAN-TU related presentations.
Assists in the development of DIAN-TU related manuscripts.
Manages and tracks DIAN-TU related presentations and manuscripts/publications by external groups.
Ensures appropriate acknowledgement of related grants.
Ensures publication upload to NIHMS system and a PMCID number is generated.
Equivalent of a Bachelor’s degree in Business Administration or related, with 5 years related experience.
Scientific professional degree (bachelors or masters degree of science, pharmacology or engineering).
Experience in managing aims and goals of large, complex efforts.
Experience in clinical research design, analysis, and execution.
Experience with writing protocols, agenda and action plans.
Critical thinking and problem solving.
Expert communication, interpersonal and organizational skills.
Excellent scientific writing skills; knowledge and application of the scientific method.
Moderate to advanced computer skills in standard office software (Microsoft Word, Excel, Powerpoint, MS Project).
Able to work independently and as part of a team.
Expertise in Gantt charts, resource management.
The hiring range for this position is commensurate with experience.
The DIAN-TU designs, develops and manages therapeutic trials for individuals with and at risk for dominantly inherited AD (DIAD) through the management of the DIAN-TU Pharma Consortium (a group of international pharmaceutical companies working together to design trials for DIAD), evaluation of therapeutic compounds, development and management of the DIAN Expanded Registry (an international registry of individuals with and at-risk for DIAD), support of ancillary studies and implementation of therapeutic trials. The DIAN-TU will be the coordinating center for major drug trials for the prevention of Alzheimer’s disease, funded through a partnership between Washington University, the National Institutes of Health (NIH), pharmaceutical companies, patient advocacy groups, and philanthropic foundations (expected total costs of >$100 million). Continual interaction with NIH, pharmaceutical companies, the Alzheimer’s Association national office, philanthropic funders, and multiple offices within Washington University will be part of this position.
-Retirement Savings Plan -22 vacation days -8 Paid Holidays -Sick Time -Tuition benefits for employee, spouse and dependent children -Free Metro Link/ Bus pass -Free Life Insurance -Health, Dental, Vision -Health Savings Accounts (HSA) -Long Term Disability Insurance -Flex Spending Plan -Other Benefits
Med School HR website (medschoolhr.wustl.edu)
Applicant Special Instructions:
Very busy office environment with frequent moderate/high pressure caused by deadlines, after hours or weekend responsibility due to urgent situations and international duties, some travel required.
Internal Applicant Instruction:
This position is grade G10.
Please attach a copy of your most current signed performance evaluation (completed within the last 18 months) to your online account. If you have not received a performance evaluation, you may provide two current signed letters of recommendation (written within the last 18 months), preferably to include one letter from either a current or recent former supervisor. To attach these documents, go to: My Career Tools, Add Attachment, Attachment Type – Performance Reviews or Letters of Recommendation.
Washington University in St. Louis, a medium-sized, independent university, is dedicated to challenging its faculty and students alike to seek new knowledge and greater understanding of an ever-changing, multicultural world. The University offers more than 90 programs and almost 1,500 courses leading to bachelor's, master's and doctoral degrees in a broad spectrum of traditional and interdisciplinary fields, with additional opportunities for minor concentrations and individualized programs. The faculty is composed of scholars, scientists, artists and members of the learned professions. They serve society by teaching; by adding to the store of human art, creativity, understanding, and wisdom; and by providing direct services, such as health care.