Director Clinical Scientist at Johnson & Johnson in Spring House, PA
The primary focus of the Director Clinical Scientist within Immunology Translational Science and Medicine (TSM) is to serve as a bridge between the preclinical Discovery Research and TSM groups into Clinical Development for New Molecular Entities (NMEs). The Director Clinical Scientist leads a group of Clinical Scientists (CS) responsible for designing clinical studies outlined in the early development plan (EDP), and for selected studies, the Director Clinical Scientist functions in the role of a Study Responsible Scientist (SRS) on early development trial teams. The CS team works with Global Clinical Development Operations (GCDO) and the entire Trial Team to efficiently and effectively operationalize early development studies. In close collaboration with Strategy Program Leads, the Director will drive design of, conduct, and provide analysis of Experimental Medicine and interventional Translational studies. This work is at its core a deep collaboration between Disease Area experts, Translational Science (Biomarker) experts, Immunologic Pathway experts and many other essential development functions. TSM is an integrated group of scientists that includes a biomarkers group and a clinical group which conducts early clinical development and experimental medicine studies. Janssen Immunology has a history of bringing life-changing therapies to patients with immune-mediated diseases. The TSM group will provide the key learnings/insights on the next wave of novel therapies for these patients. We are looking for someone with a BS, MS, MD, PharmD, PhD or RN background, industry experience, and ideally a scientific background in Immunology, to join this collaborative research group, and help us bring these new therapies to patients. Additional responsibilities are as follows:
Collaborate with Discovery Research, Translational Science and Medicine, Clinical Pharmacology and Pharmacometrics, Global Clinical Operations (GCDO), and others to implement biomarker and translational research plans for early development programs. Oversees and drives the implementation of innovative trial designs including adaptive, platform and basket trials through the creation and approval of a clinical protocol May lead the EDT (Early Development Teams) that creates the development strategy for NMEs. Represents TSM Trial Team at project functional stage-gate reviews. Participates in cross-functional trial teams. Helps to identify and collaborate with consultants, investigators, and key opinion leaders to optimize the preparation of early development strategies. Participates in the presentation of results and updates of projects at department, project, corporate and scientific meetings. Participates in identification and implementation of process improvement / shared learnings (eg, excellence initiatives, group management of operational processes, ensure best practices sharing) in TSM as well as through Immunology TA initiatives and cross-Pharma initiatives, as applicable. Active contributor to core team leading initiative to improve the execution of early development TSM studies Qualifications BS, MS, MD, PharmD, PhD or RN (or equivalent degrees) with at least 5
years industry experience in this or similar role preferred. Clinical Development experience is required. Experience with early development studies (eg, Ph 0, 1 and 2a) studies and experience in immunology indications is preferred. Experience with innovative trial designs (adaptive, platform, bucket) is preferred. Ability to survey and interpret the scientific literature related to the assigned projects is required. Working knowledge of the use of Microsoft suite of software products including Excel and Word is required. Ability to do more complex data analysis with Excel or similar programs is preferred. Willingness and ability to travel, including trans-Atlantic travel (up to 10%) may be required. Interactive team member with strong interpersonal skills. The ability to advise, persuade, and negotiate with colleagues in a supportive and collegial fashion. Strong project and time management skills. Strong organizational skills and the ability to work well in a dynamic environment and be able to prioritize and respond to changing needs of the business. The ability to work in a matrix organization with (virtual) cross-functional teams is required. Ability to operate with limited day to day supervision is required Ability to work under pressure to meet deadlines
Salary Range:
$80K -- $100K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
Collaborate with Discovery Research, Translational Science and Medicine, Clinical Pharmacology and Pharmacometrics, Global Clinical Operations (GCDO), and others to implement biomarker and translational research plans for early development programs. Oversees and drives the implementation of innovative trial designs including adaptive, platform and basket trials through the creation and approval of a clinical protocol May lead the EDT (Early Development Teams) that creates the development strategy for NMEs. Represents TSM Trial Team at project functional stage-gate reviews. Participates in cross-functional trial teams. Helps to identify and collaborate with consultants, investigators, and key opinion leaders to optimize the preparation of early development strategies. Participates in the presentation of results and updates of projects at department, project, corporate and scientific meetings. Participates in identification and implementation of process improvement / shared learnings (eg, excellence initiatives, group management of operational processes, ensure best practices sharing) in TSM as well as through Immunology TA initiatives and cross-Pharma initiatives, as applicable. Active contributor to core team leading initiative to improve the execution of early development TSM studies Qualifications BS, MS, MD, PharmD, PhD or RN (or equivalent degrees) with at least 5
years industry experience in this or similar role preferred. Clinical Development experience is required. Experience with early development studies (eg, Ph 0, 1 and 2a) studies and experience in immunology indications is preferred. Experience with innovative trial designs (adaptive, platform, bucket) is preferred. Ability to survey and interpret the scientific literature related to the assigned projects is required. Working knowledge of the use of Microsoft suite of software products including Excel and Word is required. Ability to do more complex data analysis with Excel or similar programs is preferred. Willingness and ability to travel, including trans-Atlantic travel (up to 10%) may be required. Interactive team member with strong interpersonal skills. The ability to advise, persuade, and negotiate with colleagues in a supportive and collegial fashion. Strong project and time management skills. Strong organizational skills and the ability to work well in a dynamic environment and be able to prioritize and respond to changing needs of the business. The ability to work in a matrix organization with (virtual) cross-functional teams is required. Ability to operate with limited day to day supervision is required Ability to work under pressure to meet deadlines
Salary Range:
$80K -- $100K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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