Associate Director/Director Clinical Sciences
1 month ago
Celldex Therapeutics
Associate Director/Director Clinical Sciences
New Haven ,
Connecticut
Apply Now
Join a growing Clinical Science team where you will work directly with the VP, Clinical Science. You will support Celldexs clinical development programs by contributing to the design, data collection, and reporting of clinical studies in a manner consistent with industry standards, applicable regulations and clinical development strategy. This position assembles, interprets, and presents scientific and medical data. Responsibilities will also include evaluation of clinical outcome measures, data review and trial startup activities.
Responsibilities
Working with CMO, VP, Clinical Science and medical directors, contribute to the development of clinical protocols/amendments by performing literature review/analysis and soliciting input from medical, statistical and operational, as well as pre-clinical, resources.
Ensure clinical data collection proceeds in a manner consistent with strategic objectives and regulatory requirements for reporting (i.e., collaborate with statisticians to produce statistical analysis plans and data displays; provide input to CRF design and data management processes; perform periodic review of clinical data).
Participate in planning for interim data analyses and reviews, including Data Safety Monitoring Board (DSMB) meetings.
Working with the medical director, monitor and evaluate emerging clinical data.
Review/interpret data to produce strategically relevant abstracts, presentations and manuscripts.
Author (and/or work with medical writer to develop) clinical documents including but not limited to: clinical protocols, briefing documents, IND annual reports, Investigator's Brochures, clinical protocols and amendments, clinical study reports, scientific manuscripts and abstracts, posters and scientific presentations.
Qualifications
5-10 years of experience in clinical research setting, including medical writing and oversight of (or close collaboration with) data management/analysis/reporting functions.
MS/MA degree or equivalent in a scientific or health care field required. PhDs preferred.
Experience authoring clinical protocols, regulatory documents (IND sections, clinical study reports, investigator brochures), as well as scientific publication and presentations.
Ability to collaboratively develop relationships with physicians, expert consultants, and contracted vendors.
At least 2 years of experience in immunology and inflammation preferred.
Strong analytical mind, excellent written/verbal communication skills, attention to detail, organizational skills, and ability to work independently and as part of a team.
Strong document management skills, including proficiency with MS Office Suite.
Strong medical writing skills: takes ownership of document, organizes timeline, works with other co-authors, resolves discrepancies and edits to achieve consistency, uses precise accurate language and grammar
Knowledge and experience in clinical development
Ability to multitask to meet timelines under changing conditions.
#J-18808-Ljbffr
-
Director of Clinical Science
4 weeks ago
New York, United States Child Mind Institute Full timeJob DescriptionJob DescriptionSummary: The Child Mind Institute is seeking a Director of Clinical Science for the Child Mind Medical Practice (CMMP) and School and Community Programs (SCP) who will lead efforts to integrate science and clinical practice across these programs. The person in this role will lead efforts to evaluate the effectiveness of...
-
Director of Clinical Science
2 months ago
New York, United States Child Mind Institute Full timeJob DescriptionJob DescriptionSummary: The Child Mind Institute is seeking a Director of Clinical Science for the Child Mind Medical Practice (CMMP) and School and Community Programs (SCP) who will lead efforts to integrate science and clinical practice across these programs. The person in this role will lead efforts to evaluate the effectiveness of...
-
Associate Director, Learning Engagement
1 week ago
New Haven, United States Yale University Full timeLibrary - Marx Science and Social Science Library - 88529BR **University Job Title** - Associate Director, Engagement, Science and Social Science, Marx Library **Bargaining Unit** - None - Not included in the union (Yale Union Group) **Time Type** - Full time **Duration Type** - Regular **Compensation Grade** - library **Compensation Grade Profile** -...
-
Associate Director, Research Engagement
1 month ago
New Haven, United States Yale University Full timeYale University Library seeks an innovative leader to join a newly formed team as the inaugural Associate Director, Research Engagement, and to reenvision research and learning support for the sciences and social sciences. Reporting to the Director, Director, Associate, Research, Engagement, Support, Science, Education
-
Associate Director, Clinical Outsourcing
4 weeks ago
New Haven, United States Arvinas Inc. Full timeArvinas is a clinical-stage biotechnology company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary PROTAC Discovery Engine platform to engineer proteolysis targeting...
-
Associate Director, Clinical Outsourcing
2 weeks ago
New Haven, United States Arvinas Inc. Full timeArvinas is a clinical-stage biotechnology company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary PROTAC Discovery Engine platform to engineer proteolysis targeting...
-
Associate Director, Clinical Outsourcing
3 weeks ago
New Haven, United States Arvinas Full timeArvinas is a clinical-stage biotechnology company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary PROTAC Discovery Engine platform to engineer proteolysis targeting...
-
Associate Director, Research Engagement
3 weeks ago
New Haven, United States Yale University Full timePosition Focus: Yale University Library seeks an innovative leader to join a newly formed team as the inaugural Associate Director, Research Engagement, and to reenvision research and learning support for the sciences and social sciences. Reporting to the Director, Science and Social Science, the Associate Director provides vision and leadership for...
-
Associate Director, Learning Engagement
4 weeks ago
New Haven, United States Yale University Full timePosition Focus: Yale University Library seeks an innovative leader to join a newly formed team as the inaugural Associate Director, Learning Engagement, and to reenvision research and learning support for the sciences and social sciences. Reporting to the Director, Science and Social Science, the Associate Director provides vision and leadership for...
-
Associate Director, Research Engagement
2 weeks ago
New Haven, United States Yale University Full timePosition Focus: Yale University Library seeks an innovative leader to join a newly formed team as the inaugural Associate Director, Research Engagement, and to reenvision research and learning support for the sciences and social sciences. Reporting to the Director, Science and Social Science, the Associate Director provides vision and leadership for...
-
Associate Director, Learning Engagement
3 weeks ago
New Haven, United States Yale University Full timePosition Focus: Yale University Library seeks an innovative leader to join a newly formed team as the inaugural Associate Director, Learning Engagement, and to reenvision research and learning support for the sciences and social sciences. Reporting to the Director, Science and Social Science, the Associate Director provides vision and leadership for...
-
Associate Director, Clinical Outsourcing
4 weeks ago
New Haven, Connecticut, United States Arvinas Inc. Full timeArvinas is a clinical-stage biotechnology company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary PROTAC Discovery Engine platform to engineer proteolysis targeting...
-
Clinical Director
2 months ago
New Haven, United States Affinity Hospice Management LLC Full time**Job Title/Position**: _Clinical Director_ **Reports To**: _Executive Director/Administrator_ **JOB DESCRIPTION SUMMARY** The Clinical Director is responsible for the overall direction of hospice clinical services. The Clinical Director establishes, implements and evaluates goals and objectives for hospice services that meet and promote the standards of...
-
Clinical Director
2 weeks ago
New Haven, United States Affinity Hospice Management LLC Full time**Job Title/Position**: _Clinical Director_ **Reports To**: _Executive Director/Administrator_ **JOB DESCRIPTION SUMMARY** The Clinical Director is responsible for the overall direction of hospice clinical services. The Clinical Director establishes, implements and evaluates goals and objectives for hospice services that meet and promote the standards of...
-
North Haven, Connecticut, United States Quinnipiac University Full timeThe Department of Social Work at Quinnipiac University is seeking a dynamic and experienced professional to join our School of Health Sciences as a Full-Time Clinical Faculty and Associate Director of its new Online Master of Social Work (MSW) Progra Director, Faculty, Clinical, Associate, Health Science, Program Director
-
North Haven, United States Quinnipiac University Full timeThe Department of Social Work at Quinnipiac University is seeking a dynamic and experienced professional to join our School of Health Sciences as a Full-Time Clinical Faculty and Associate Director of its new Online Master of Social Work (MSW) Progra Director, Faculty, Clinical, Associate, Health Science, Program Director
-
Associate Director
1 week ago
New York, United States NYU Langone Health Full timeWe have an exciting opportunity to join our team as an Associate Director - Clinical Research Systems.In this role, the successful candidate oversees the delivery of technology solutions supporting all Clinical Research IT systems. The Associate Director leads a growing team of individuals to support single-site and multi-site projects including product...
-
Associate Director, Clinical Services
2 months ago
New Orleans, United States Tulane University Full timeThe Associate Director is part of the Tulane University Campus Health team of committed professionals dedicated to supporting and promoting student health and wellbeing as a core institutional value through a multidisciplinary, comprehensive approach. This position resides within the Counseling Center and reports to the Counseling Center Director. The...
-
Associate Director, Clinical Services
3 weeks ago
New Orleans, United States Tulane University Full timeThe Associate Director is part of the Tulane University Campus Health team of committed professionals dedicated to supporting and promoting student health and wellbeing as a core institutional value through a multidisciplinary, comprehensive approach. This position resides within the Counseling Center and reports to the Counseling Center Director. The...
-
Associate Director, Clinical Services
2 months ago
New Orleans, United States Tulane University Staff Full timeThe Associate Director is part of the Tulane University Campus Health team of committed professionals dedicated to supporting and promoting student health and wellbeing as a core institutional value through a multidisciplinary, comprehensive approach. This position resides within the Counseling Center and reports to the Counseling Center Director. The...
