Clinical Scientist (Manager)

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 Boston, MA, USA.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal.Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.
Are you looking for an opportunity to work with an integrated group of scientists thriving on a diverse company culture? In the Translational Sciences and Medicine (TSM) group, we celebrate the uniqueness of each employee and are committed to diversity and inclusion. We have a history of bringing life-changing therapies to patients with immune-mediated diseases. As a part of this group, you will provide the key learnings and insights on the next wave of novel therapies for these patients.
As a Manager, Clinical Scientist within Immunology TSM, you will serve as a key member of early development clinical trial teams, partnering with the team designing and executing clinical studies outlined in the product development plan (PDP). This work is a deep collaboration between a number of essential development functions. You will partner with Global Development Operations (GDO) and the entire Trial Team to efficiently and effectively operationalize the studies. You will assume the role of a Manager, Clinical Scientist on cross functional trial teams and workgroups. You will support the team designing Phase 0, 1 and 2a clinical studies. The Manager, 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.
We are looking for someone with a BS, MS, PharmD, PhD or research nursing (RN) background, proven 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) specialists, 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 Manager, Clinical Scientist 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 Manager, 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 figure out best disease indications for the project. The Manager, 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.
Responsibilities include:

• 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.

Qualifications

• BS, MS, PharmD, PhD or RN preferably with a scientific background in Immunology or a related field, and 4-8 years proven 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 social 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 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.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

IMPACTIMM

Primary Location
United States-Massachusetts-Cambridge-MA Cambridge Binney
Organization
Janssen Research & Development, LLC (6084)
Job Function
R&D
Requisition ID
2105888179W