Associate Director Biomarker Discovery Research - located in Bethesda MD

Massachusetts General Hospital is an Equal Opportunity Employer. By embracing diverse skills perspectives and ideas we choose to lead. Applications fromprotected veterans and individuals with disabilities are strongly encouraged. GENERAL SUMMARY/ OVERVIEW STATEMENT: Serve as the primary contact and lead biologist for the asthma & allergic disease therapeutic area. Design and develop mechanism of action (MOA) studies for clinical trials and will analyze and interpret data generated from MOA studies. Lead collaborative efforts for assay design development and data interpretation with ITN Principle Investigators and Core Laboratory Directors. Write/cowrite original research manuscripts for publication.Along with the Program Director determine the direction of research projects related to support of ITN clinical trials including decisions regarding implementation of new technologies use of existing assays and providing cost assessments for projects. Additionally assess assay costs and negotiate with vendors etc. to secure the most efficient and cost effective approaches for MOA studies. Participate in the development of new laboratory or data analysis methods that may lead to intellectual property.Oversee mechanistic assay study design and identification of mechanistic assays. Write implement and ensure adherence to standard operating procedures for assays. Develop and oversee of all protocols. Manage project direction including sample utilization and patient feasibility issues. Additionally plan manage and execute data analysis studies that lead to publication of original findings in keeping with publications policies.This PhD position requires independent scientific and critical thinking skills with a strong background in immunology and translational medicine. Must be able to communicate effectively with a range of colleagues including key opinion leaders clinical trial physicians NIAID medical monitors regulatory officers industry representatives ITN Bioinformatics (BIO) group and ITN mechanistic operations group. The Program Manager will also be expected to maintain ongoing communication with the Biomarker & Discovery Research leaders. Candidates with expertise in asthma & allergic disease preferred but not required. PRINCIPAL DUTIES AND RESPONSIBILITIES: Protocol Development Design a subset of MOA studies working with PIs ITN senior scientific leadership disease and assay area experts. 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 the Director. Write MOA section of the protocol in collaboration with key opinion leaders PIs and the ITN CTG and Biomarker & Discovery Research groups. Develop Schedule of Events with ITN CTG. This requires a working knowledge of blood volume considerations and IRB concerns in order to balance feasibility with scientific questions to be addressed. Present protocol background general scientific rationale and study design to the ITN Biomarker & Discovery Research for transition to this group. Review and provide input on protocols and amendments that impact MOA studies for Senior Director and Executive Director for final sign off. Assay Design and Development Work with the ITN Biomarker & Discovery Research group ITN science leadership PIs and area experts to develop new assays for use in ITN protocols. Present recommendations to ITN Executive Director for discussion and approval. Design develop and write new protocols for development of new assays or for observational studies that will lead to discovery of disease or therapy specific biomarkers. Direct Biomarker & Discovery Research group in the design procedures and development of new molecular and cellbased assays. Survey the literature and the community for new technologies techniques or assays that may be of use to the ITN mission. Provide oversight of the management and quality of all ITN central laboratory cores such that they are all meeting GLP standards and are providing assay results in a timely and cost effective manner while maintaining the highest quality of service. Data Analysis and Interpretation Work extensively with the Bioinformatics group and Biomarker & Discovery Research leadership to review and interpret data from MOA studies. This is an iterative process that requires strong analytical skills and an in depth knowledge of immunology molecular biology the assays being used and the scientific questions posed by the protocol. Work with the above mentioned groups and persons to define data sets that can be used for publication and make recommendations to Biomarker & Discovery Research leadership. Work with the above mentioned groups to write manuscripts for submission to scientific journals along with Biomarker & Discovery Research leadership. Work with the above mentioned groups to develop presentations for scientific conferences. Prepare presentations of scientific data at NSC meetings internal meetings and at national and international scientific conferences. Work with the ITN Biomarker & Discovery Research group to ensure high quality data reporting and assay results at the ITN Data Center. Communication Prepare and provide weekly updates for ITN Scientific leadership. Correspond in both technical and lay language with a wide variety of ITN collaborators and constituents. Write project summaries annual report sections proposals and letters for collaborating investigators. Project Oversight Provide oversight of protocol development timelines for ITN Biomarker & Discovery Research Write ITN Biomarker & Discovery Research Mechanistic Assay Plan Data Analysis Plan and other Biomarker & Discovery Research specific documents. Work with ITN Biomarker & Discovery Research leadership and NCO to outline Biomarker & Discovery Research and MOA budgets. SKILLS/ABILITIES/COMPETENCIES REQUIRED: Operate with minimal guidance in the areas of immediate responsibility except in rare or unusual circumstances. Effectively manage a wide range of scientific and management issues on a routine basis using extensive scientific knowledge and judgment. Working knowledge of molecular biology with an emphasis on humansin particular clinical trials familiarity with commonly used data analysis tools to design MOA studies in each protocol and to analyze and interpret data sets derived from the MOA and clinical results that constitute the data set from each clinical trial protocol. Appropriately develop MOA studies to address how immunotherapies are inducing or maintaining tolerance. Extensive knowledge of tolerance inducing therapies and biological assessment. Execute projects and ensure quality by working effectively with others and seeking direction as needed. Extensive knowledge of immunology and molecular biology to develop and execute complex assays that address therapeutic efficacy and tolerance. Strong analytical skills and a background in statistics and genomics data analysis tools are desired for data analysis and interpretation. Ability to extrapolate complex scientific principles from one area to another and to integrate analytical techniques and think across scientific areas in an informed and unique way is central for this position. 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. Independent judgment and ability to manage people including ability to keep the team and trial on track and to move through the process of protocol development and data analysis requires the ability to communicate on many levels on a wide range of issues. 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. Additionally conflict of interest policies must be followed. Knowledge of MGH intellectual property guidelines and policies for publication must also be followed. Strong record keeping and organizational skills are required for the collection analysis and storage of data from scientific assays and uploading of data to ITN databases and maintenance of databases. LICENSES CERTIFICATIONS and/or REGISTRATIONS (if applicable): None EDUCATION: PhD in Immunology or related field EXPERIENCE: 35 years relevant laboratory work and management experience is required experience in human studies preferred.Experience with cell biology flow cytometry microarray and PCR technologies is a must.Experience is necessary in writing protocols detailed scientific documents and original manuscripts for publication and for giving presentations to scientific and nonscientific professional in a wide variety of meetings. SUPERVISORY RESPONSIBILITY (if applicable): None FISCAL RESPONSIBILITY (if applicable): WORKING CONDITIONS: Normal office conditions. This position has physical job requirements such as standing walking climbing stairs reaching lifting and pulling weight up to 20 pounds.