An experienced Staff Scientist position is currently available to support Diabetes TrialNet’s mechanistic study portfolio. Diabetes TrialNet is an international NIH sponsored clinical trials network with the mission to preserve beta cell function in type 1 diabetes before or after clinical diagnosis. The position is part of the office of the TrialNet Chair, located in the Diabetes Clinical Research Program at Benaroya Research Institute at Virginia Mason (BRI). The staff scientist will report to the TrialNet Chair. BRI is an independent research institute, focused on finding the causes and cures of autoimmune and immune-mediated diseases (e.g. type 1 diabetes, multiple sclerosis, rheumatoid arthritis, allergies, and asthma).
The successful applicant will interface with TrialNet’s Collaborative Mechanistic Studies Panel (CMSP), TrialNet’s Coordinating Center (TNCC), and scientific collaborators within and external to TrialNet to optimize and implement TrialNet’s mechanistic portfolio. This portfolio currently includes (a) Key Questions; TrialNet developed mechanistic studies using existing samples, (b) Mechanistic studies embedded in TrialNet clinical trials, and (c) Collaborative research studies with stored or newly obtained samples. The applicant will facilitate data integration across studies and collaborative efforts between investigators within and external to TrialNet with respect to assay selection, mechanistic study design, sample and subject selection, and data sharing and analysis.
This position requires independent scientific and critical thinking as well as organizational skills with a strong background in project management, and translational medicine. Strong preference will be given to those with expertise in immunology, type 1 diabetes and/or beta cell biology. Must be able to communicate effectively, verbally and in writing, with a range of colleagues including members of the TrialNet Collaborative Mechanistic Studies Panel, NIDDK program officers, and TrialNet leadership, protocol PI’s, clinical center directors and study coordinators, collaborating investigators, TrialNet coordinating center statisticians, protocol/project managers and research assistants, TN medical monitor, regulatory officers, industry representatives, and other relevant groups [e.g. JDRF, ADA, Immune Tolerance Network (ITN)].
• Coordinate and facilitate operations for collaborative projects with JDRF, ADA, ITN, industry, and others as indicated.
• Provide oversight of mechanistic study timelines for CMSP
• In collaboration with CMSP, write Mechanistic Assay Plan, Data Analysis Plan and other CMSP specific documents as requested.
• Work with TNCC and CMSP to outline mechanistic study budgets.
• Prepare and provide weekly updates for CMSP and TN Scientific leadership.
• Support CMSP meetings and conference calls including preparation of agenda, action items, tracking of progress.
• Correspond in both technical and lay language with a wide variety of TN collaborators and constituents.
• Draft required documents such as project summaries, annual report sections, proposals and letters for collaborating investigators.
Assay Design and Development
• Survey the literature and the community for new technologies, techniques or assays that may be of use to the TN mission
• Work with the TN CMSP, TN science leadership, PI’s and area experts to evaluate new assays for use in TN protocols. Present recommendations to TN scientific leadership for discussion and approval.
Data Analysis and Interpretation
• Work extensively with the TNCC and CMSP leadership to review and interpret data from mechanistic studies.
• Work with the above mentioned groups and persons to define data sets that can be used for publication and make recommendations to CMSP and TN leadership.
• Work with the above mentioned groups to write manuscripts for submission to scientific journals along with TN members.
• Draft presentations of scientific data at TN steering co meetings, internal meetings and at national and international scientific conferences.
• Work with the CMSP group to ensure high quality data reporting and assay results at the TNCC
• Working with TNCC, CMSP, PI’s and TN scientific leadership, and external collaborators, facilitate design of mechanistic studies. This requires a thorough understanding of the biology of the disease as well as extensive knowledge of the therapy to be tested. The incumbent will be expected to obtain this background information through the literature, as well as through discussions with experts and TN members.
• Work with protocol committees in writing mechanistic section of the protocol in collaboration with TNCC and CMSP.
• Work with protocol committees and TNCC to develop a Schedule of Events. This requires a working knowledge of blood volume considerations and IRB concerns in order to balance feasibility with scientific questions to be addressed.
• Strong project management and organizational skills are required.
• Independent judgment and ability to manage people with diverse expertise and knowledge, including ability to keep the team and projects on track.
• Must have excellent written and verbal communication skills
• Effectively manage a wide range of scientific and management issues on a routine basis using extensive scientific knowledge and judgment.
• Execute projects and ensure quality by working effectively with others and seeking direction as needed. Generally operate with minimal guidance in the areas of immediate responsibility.
• Working knowledge of translational immunology, molecular and beta cell biology, with an emphasis on humans--in particular clinical trials, familiarity with commonly used data analysis tools to analyze and interpret data sets derived from mechanistic studies.
• Knowledge of feasibility and regulatory issues confronting the conduct of research intensive clinical trials, including risk benefit assessments. Understand IRB policies, clinical trials procedures, and scientific conduct ethics.
• Must be able to leverage extensive knowledge in science and assay techniques to place data findings in the larger context of the questions to be addressed. Keen analytical skills and the ability to see the larger picture or themes that are emerging from the findings are required. Ability to distill a comprehensive story from data into a manuscript as well as strong communications skills are needed, including with staff and vendors.
• Interact with the highest level of professionalism in all conversations, correspondence and meetings. Extensive preparation, ability to think critically and quickly on the spot, as well as the ability to project confidence and competence in public forums is necessary.
The successful candidate will have an advanced degree (MD, PhD or equivalent), with a minimum of 3 years of experience in translational laboratory based research.
The candidate must also have experience in laboratory and/or project management and previous science writing experience. Previous exposure to budgeting for grants and formal training in statistical analysis are both a plus. Priority for those with type 1 diabetes research and clinical trial experience.