Biotech and Agricultural Medical and Healthcare Other Science and Tech
3 - 5 Years
Clinical Scientist Manager Translational Medicine
Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Clinical Scientist (Manager), Immunology Translational Science and Medicine to be located in Leiden, NL or Spring House, PA.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in the following therapeutic areas: immunology, oncology, neuroscience, infectious diseases & vaccines, cardiovascular & metabolism, and pulmonary hypertension. Please visit http://www.JanssenRnD.com for more information.
We are Janssen. Our mission drives us. Our patients inspire us. Our CREDO guides us. https://www.jnj.com/credo/ We collaborate with the world for the health of everyone in it.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
TSM is an integrated group of scientists that includes a Translational Science biomarkers and digital health group, and a Translational Medicine clinical group which designs and conducts early clinical development and experimental medicine strategy and associated clinical and experimental 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, PharmD, PhD or research nursing (RN) background, industry experience, and preferably a scientific background in Immunology or related field, to join this collaborative research and development group, and help us bring these new therapies to patients.
The primary focus of this Manager, Clinical Scientist position within Immunology Translational Science and Medicine (TSM) is to serve as a key member of early development clinical trial teams partnering and leads the team designing and execution of clinical studies outlined in the product development plan (PDP). 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 Clinical Scientist partners with Global Development Operations (GDO) and the entire Trial Team to efficiently and effectively operationalize the studies.
The Clinical Scientist Manager functions in the role of a Study Responsible Scientist (SRS) on cross functional trial teams, and workgroups, is competent in the role and with minimal supervision, leads the team designing Phase 0, 1 and 2a clinical studies. In addition, the Clinical Scientist may also contribute to the scientific and strategic content of the product development plan or contribute to the scientific evaluation of new disease pathways and targets, helping determine the best disease indications for the project. The Clinical Scientist will work closely with cross functional partners to implement translational science and digital health strategies or sub-studies in all phases of clinical development.
Collaborating with other team members within TSM (e.g. working closely with SRP), supporting the design, execution, analysis, and presentation of TSM studies.
Collaborating with Discovery Research, Translational Science, Clinical Pharmacology and Pharmacometrics, Global Development Operations (GDO), and others to implement biomarker and translational research plans for early development programs.
In collaboration with Immunologic Pathway experts and Program leads, may be asked to contribute to the development of the scientific background and strategic content of the product development plan.
Supporting the GDO group with trial set up, conduct, and monitoring, and database locks
Ensuring that study conduct adheres to Good Clinical Practices, International Conference of Harmony (ICH) guidelines, and standard operating procedures.
In collaboration with GDO, identifying clinical sites and CROs/Vendors that will participate in TSM trials.
Support preparation of the clinical content of drug safety documents and reports such as the investigator brochures, DSURs, and other regulatory response documents.
Interacting with staff responsible for the design, set-up, execution, analysis and reporting of these studies.
Reviewing incoming data from the study for accuracy and completeness.
Participating in the review and interpretation of clinical trial data to enable timely internal decision-making and external communication with investigators and regulatory agencies.
Participating in the preparation and assuring the accuracy of the clinical study reports as well as any external publications.
Reporting the status of clinical trials to management.
BS, MS, PharmD, PhD or RN preferably with a scientific background in Immunology or a related field, and 4-8 years industry experience is required.
Previous clinical development experience is required, experience with innovative trial designs (adaptive, platform, basket, combination therapy) preferred.
Experience with Ph 0, 1 and 2a studies in immunology indications is preferred.
Ability to survey and interpret the scientific literature related to the assigned projects is required.
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.
Good interpersonal skills and the ability to advise, persuade, and negotiate with colleagues in a supportive and encouraging fashion.
Excellent written and verbal English communication skills.
The ability to work in a global matrix organization with cross-functional teams is required.
Willingness and ability to travel including international travel is required.
Proficient with Microsoft Office applications, and other systems and tools used in early clinical development.
Netherlands-South Holland-Leiden- Other Locations
United States-Pennsylvania-Spring House Organization
Janssen Biologics (7266) Job Function
R&D Requisition ID
Open Positions from Johnson & Johnson Family of Companies