Johnson & Johnson Careers
Sr. Clinical Scientist Immunology Translational Medicine
Requisition ID: 1905777111W
The primary focus of this Clinical Scientist (CS) position within Immunology Translational Science and Medicine (ITSM) is to serve as a “bridge” between the preclinical Discovery Research and Translational Science (TS) groups into Clinical Development for New Molecular Entities (NMEs). The CS functions in the role of a Study Responsible Scientist (SRS) on early development trial teams and takes part in designing clinical studies outlined in the early development plan (EDP). 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. The CS works with Global Clinical Development Operations (GCDO) and the entire Trial Team to efficiently and effectively operationalize the studies.
ESSENTIAL FUNCTIONS: (Core Responsibilities)
- With supervision of others in ITSM, support designing, conducting, and analyzing Experimental Medicine and Early Development studies
- Collaborate with Discovery Research, Translational Science, Clinical Pharmacology and Pharmacometrics, Global Clinical Operations (GCDO), and others to implement biomarker and translational research plans for early development programs.
- May be a supervised member of the EDT/CDT (Early/Compound Development Teams) that creates the development strategy for NMEs.
- May be asked to contribute to the development of the scientific background for the target and indication exploration for the NME.
- Works closely with Biomarker and Clinical Pharmacology representatives to devise the biomarker / PK strategies (respectively) and feasibility for the early development studies that are part of the EDP.
- Study responsibilities:
- Writes the Protocol Elements Document (PED; ie synopsis) and then works with Medical writing and content contributors to complete the full protocol. Is able to address questions and comments on protocol design at Protocol Review Committee
- Partners with the GCDO group on trial preparation, initiation, conduct, monitoring, and database locks.
- Ensures study conduct adheres to Good Clinical Practices, International Conference of Harmony (ICH) guidelines, and Janssen standard operating procedures.
- Presents trial design, trial conduct updates and top line results for assigned studies to management.
- With others in ITSM, oversees certain aspects of study conduct including:
- In collaboration with GCDO, identifying clinical sites and CROs/vendors that will participate in TM trials.
- Reviews budgets of prospective clinical trials and ensures that trial costs are appropriate to meet trial objectives while minimizing unnecessary protocol elements.
- Reviews the scope of work for vendor contracts for accuracy, based upon the requirements of our protocols
- Interacts with staff responsible for the design, set-up, execution, analysis and reporting of these studies.
- Review incoming data from the study for accuracy and completeness; responsible for data review in conjunction with other clinical team members prior to database locks (iDARTS/Spotfire, listings etc)
- Supports the assessment and review of clinical safety data from studies by collecting and summarizing appropriate safety data/information for review by the Molecule Responsible Physician (MRP) and/or Study Responsible Physicians (SRPs) or Safety Management Team (SMT).
- Participates in the review and interpretation of clinical trial data to enable timely internal decision-making and external communication with investigators and regulatory agencies.
- Participates in the preparation of the clinical study report and assure the integrity of the data.
- Contributes to updates of the IB (Investigator Brochure) and regulatory documents
- Reports the status of clinical trials to management.
OTHER RESPONSIBILITIES / DETAILED DUTIES:
- May represent ITSM Trial Team at project functional stage-gate reviews.
- Participates in cross-functional trial teams.
- Helps identify and collaborate with consultants, investigators, and key opinion leaders to optimize the preparation of early development strategies.
- May participate in the presentation of results and updates of projects at department, project, corporate and scientific meetings.
- May participate in process improvement efforts (ITSM initiatives, Immunology TA initiatives and cross-Pharma initiatives, as applicable).
Contacts Inside the Company: Discovery Research, Translational Science, Non-Clinical safety (Toxicology), Clinical Pharmacology and Pharmacometrics, Regulatory Affairs, Project Management, Quantitative Sciences / Biostatistics, Data Management (IDAR), Medical Writing, Global Clinical Development Operations (GCDO), Commercial, QA/QC, Human Resources, Business Development, Compound Development Teams, cross-company Project Teams.
Contacts Outside the Company: Clinical investigators, academic researchers, study coordinators, Contract Research Organizations, Consultants, Key Opinion Leaders and Corporate Partners.
Education: BS MS PharmD PhD or research nursing (RN) background
- 4 years industry experience; Clinical Development experience is preferred.
- Ability to survey and interpret the scientific literature related to the assigned projects is preferred.
- Fluent in written and spoken English
- Working knowledge of the use of Microsoft suite of software products including Excel and Word. Ability to do more complex data analysis with Excel or similar programs is a plus.
- Good team member and interpersonal skills. The ability to advise, persuade, and negotiate with colleagues in a supportive and encouraging fashion.
- Good oral, written, and presentation skills
- Good sense of cultural sensitivity and diversity
- Project and time management skills
- Good organizational skills with the ability to multi-task and prioritize assignments
- Being able to work in a (virtual) cross-functional team environment
- Ability to operate with limited day to day supervision is required
- Ability to work under pressure to meet deadlines
- An ability to handle complex projects and to overcome delays and obstacles.
- Willingness and ability to travel, including trans-Atlantic travel (up to ~10%)
Janssen Biologics (7266)
Clinical Research non-MD