Director, Clinical Scientist, Translational Medicine

Johnson & Johnson Cambridge , MA 02138

Posted 2 months ago

Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Director, Immunology Translational Science and Medicine to be located in Cambridge, MA or La Jolla, 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 oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. 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.

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

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 is required; 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

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

#LI-LCHASE

Primary Location

United States-Massachusetts-Cambridge-MA Cambridge Binney

Organization

Janssen Research & Development, LLC (6084)

Job Function

R&D

Requisition ID

2105924450W

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 Director Translational Medicine

Johnson & Johnson

Posted 2 weeks ago

VIEW JOBS 9/28/2021 12:00:00 AM 2021-12-27T00:00 Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for an Associate Director, Translational Medicine to be located in Cambridge, MA or La Jolla, 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 oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. 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. Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer. The Associate Director, Translational Medicine (TM), will be a program and experimental medicine leader in the Immunology Translational Science and Medicine (TSM). The Associate Director, TM, will contribute to creating and implementing program translational plans that are aligned with TA disease and pathway strategies. Further, the successful candidate will contribute to shaping the strategic vision for programs as well as in creating and implementing experimental medicine studies. This role will partner with translational science to engage in external interactions with academic institutions having strong capabilities in translational studies and with external scientific experts. The Associate Director, TM, may also support Business Development activities including due diligence support. This work will include supporting clinical and scientific aspects of translational studies from Phase 0 through Proof of Concept studies. In this role, the Associate Director, TM, will decisively contribute to accelerating the Immunology pipeline from portfolio entry to Proof-of-Concept (POC). The position reports into a Senior Director of the Translational Medicine (TM) and group. Within TM, the Associate Director will be part of the Strategic Program Lead group which has primary responsibility within TSM for creating and implementing innovative translational plans for the portfolio assets. TSM is a group within the Immunology Therapeutic Area, consisting of a Translational Medicine and Translational Science (TS). TM has combined expertise in the clinical study of immunologic disease, immunologic pathways and in early clinical trial design and execution. TS has expertise in biomarker development, disease biology research and in the application of immunology and data science technologies to support drug development. Organizationally, TSM serves as a pivtoal bridge between Discovery Research and the later phase Clinical Development group. TSM provides the necessary scientific and clinical expertise to advance an industry-leading pipeline of novel mechanism small molecules and biologic agents to address unmet need in immune-mediated diseases. This position will play a 'dual role', contributing both scientific and clinical development expertise to TSM projects. Responsibilities are as follows: * Contribute to the design execution of program translational strategies integrating both disease and pathway approaches. * Contribute to the design and execution of early clinical trials through PoC including experimental medicine studies. * Support Business Development, including due diligence activities. * Represent TM on early development teams * Represent TM for project teams when presenting to portfolio, project and governance meetings * Lead or participate in cross-functional working groups such as scientific and safety review boards * Identify and collaborate with academic translational sites to optimize the translational strategy and plans for programs. * Prepare and/or direct the preparation and review of protocols, clinical study reports and translational medicine sections of Translational plans, IBs, INDs, abstracts, manuscripts, and technical reports. * Responsible for presentation of results and updates of projects at department, project, corporate and scientific meetings. Qualifications * MD or MD/PhD degree is required * Industry and/or translational research experience is preferred. * Training in Immunology is strongly preferred. * Subspecialty medical training in Dermatology, Gastroenterology or Rheumatology is preferred. * Willingness and ability to travel, including trans-Atlantic travel (up to ~10%) is 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. impactimm #LI-LCHASE Primary Location United States-Massachusetts-Cambridge-MA Cambridge Binney Organization Janssen Research & Development, LLC (6084) Job Function R&D Requisition ID 2105928311W Johnson & Johnson Cambridge MA

Director, Clinical Scientist, Translational Medicine

Johnson & Johnson