Manager, Clinical Scientist - Immunology

Johnson & Johnson Boston , MA 02298

Posted 2 months ago

Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for an Associate Director, Clinical Development, Immunology, to be located in Cambridge, MA, Spring House, PA, or San Diego, CA.

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. We collaborate with the world for the health of everyone in it. We are guided by our Credo. https://www.jnj.com/credo/

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

Position Overview:

The focus of the Manager, Clinical Scientist is to support various clinical research tasks associated with assigned Immunology Development clinical trials, program execution, innovation, and optimization of execution. Scope of work will include tasks associated with the execution, monitoring, and reporting results of clinical trials evaluating therapeutics in immunologic disorders. The range of tasks may vary to some degree depending on the therapeutic area and trial-specific requirements.

The Clinical Scientist is a key member of development clinical trial teams, works in collaboration with Study Responsible Clinical Scientist and in partnership with Project Physician(s). The Clinical Scientist provides active scientific contribution to a cross-functional clinical team developing a molecular entity. Provides input to the clinical development plan, works on the development of the clinical trial protocol, clinical trial materials, supports completion of clinical study reports and preparation of relevant documents for regulatory filings. This role involves extensive team matrix interactions with colleagues from different disciplines.

Responsibilities include:

  • Supports activities related to the design, execution, monitoring, and reporting of clinical trials.

  • Supports preparation of clinical development plans, trial protocols, case report forms, study operational plans

  • Supports medical monitoring activities and reporting in partnership with Study Responsible Clinical Scientist and Study Responsible Physician, evaluates clinical trial adverse events, reviews clinical laboratory results, drafts adverse event narratives.

  • Partners with Clinical Operations in trial set up, conduct, recruitment activities, closeout, and reporting

  • Assists Data Management with the review of clinical data and query resolution

  • Works closely with Quality Management & Assurance to ensure flawless execution of clinical trials

  • Supports completion of clinical study reports

  • Supports responses to questions from Ethics Committees and Health Authorities

  • Supports integrated document development for marketing authorization filing and preparation for the FDA Advisory Committee and EU Oral Explanation

  • Reviews medical literature and related new technologies

Qualifications

  • BS, MS, PharmD, PhD or RN preferably with a scientific background in Immunology or a related field, and 5 years industry experience or equivalent clinical research experience is required.

  • Experience in late-stage drug development, experience in immuno-inflammatory 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.

  • Proficient with Microsoft Office applications EXCEL, POWERPOINT, and WORD.

  • 10-20% domestic/international travel may be required.

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.

Primary Location

United States-Pennsylvania-Spring House-Welsh & McKean Roads

Other Locations

North America-United States-Massachusetts-Boston, North America-United States-California-La Jolla

Organization

Janssen Research & Development, LLC (6084)

Job Function

R&D

Requisition ID

2206064694W


icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Associate Scientist Immunology

Abbvie, Inc

Posted 1 week ago

VIEW JOBS 9/20/2022 12:00:00 AM 2022-12-19T00:00 <p>AbbVie's Immunology R&amp;D organization is expanding its early discovery team at the Immune Profiling Center in Boston. We seek a highly motivated Associate Scientist with excellent attention to detail and an avidity for learning new techniques and methodology related to multi-omics, including bead-based immunoassay for multiplex detection, single-cell proteomic, spectral, and mass flow cytometry, etc. in our Translational and Transformational Immunology Discovery team. This scientist will specifically support target identification and validation efforts by learning and working in a multi-omics center and collaborating with different teams across R&amp;D and other departments at AbbVie. The perfect candidate should have previous immunology/cell biology knowledge and techniques related to those fields (ELISA, qPCR, flow cytometry, etc.). Previous experience working in an academic or industry laboratory and experience handling human and mouse cells will be a plus for consideration. This position requires a passion for learning, attention to detail, good communication, and teamwork.</p><p>Qualification and key responsibilities:</p><ul><li><p>B.S. or M.S. in cell biology, immunology, molecular biology, biomedical engineering, or closely related disciplines, with lab experience in an academic or industry setting.</p></li><li><p>Incorporate relevant external sources (literature, patents, conferences) and state-of-the-art technologies and theories to solve scientific questions within target identification and validation.</p></li><li><p>Streamline methods to measure cytokines/chemokines and run a different type of samples (PBMCs, tissue, cultured cells, …)</p></li><li><p>Ability to troubleshoot problems and provide possible solutions</p></li><li><p>Ability to properly maintain lab notebook with accurate and detailed record-keeping.</p></li><li><p>Establish/update SOP and technical reports, protocols, and other critical documents for all relevant processes</p></li><li><p>Contribute to discussions for experimental design and assay development and the interpretation of results.</p></li><li><p>Support the organization by maintaining a work environment focused on scientific integrity and fostering learning, open communication, and collaboration.</p></li><li><p>Excellent verbal and written communication skills with the ability to prepare and present experimental plans and results in group meetings</p></li></ul><p>Preferred Qualifications:</p><ul><li><p>Hands-on experience with cell isolation, cell culture, cell-based assays, and general molecular biology techniques. Working knowledge of fundamental immunological principles</p></li><li><p>Hands-on experience in developing and performing standard immunology assays to address specific biological questions for target identification and validation ELISA/Luminex assays, proliferation, and killing assays</p></li><li><p>Knowledge of or willing to learn assay automation using TECAN or Biomek platforms</p></li><li><p>Excellent organization and planning skills, the ability to work in a fast-paced environment independently or as part of a team, strong motivation with a dedicated work ethic.</p></li><li><p>Knowledge or willingness to learn flow/mass cytometry</p></li></ul><p>Position will be hired based on level of experience.</p><p>Significant Work Activities: N/A</p><p>Travel: No</p><p>Job Type: Experienced</p><p>Schedule: Full-time</p><br> Abbvie, Inc Boston MA

Manager, Clinical Scientist - Immunology

Johnson & Johnson