Director, Translational Medicine Program Lead- Immunology

Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Director, Translational Medicine to be located in Spring House, PA, Cambridge, MA or La Jolla, CA. Remote work options may be considered on a case-by-case basis and if approved by the Company.

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 Director, Translational Medicine (TM), will be a program and experimental medicine leader in the Immunology Translational Science and Medicine (TSM) function. In this position, the Director, TM, will decisively contribute to accelerating the Immunology pipeline from portfolio entry to Proof-of-Concept (PoC). 

The Director, TM, will function as a clinical lead/study responsible physician on early development programs and trials. They will contribute to creating translational plans for programs that are aligned with overall TA strategy and with relevant disease area and/or pathway strategies.   They will be empowered to lead a cross-functional clinical trial team to deliver on the trial’s major execution milestones within governance-approved timeline and budget commitments.  This responsibility extends end to end for clinical trials: from initial protocol design to continued monitoring and problem solving on trial execution to the analysis, interpretation, and communication of study results.  This role will partner with translational science and deep engagement with investigators and external experts is expected.  In this leadership role they will be supported by the senior leaders within the Translational Science and Medicine function, including the relevant disease area leaders (both in clinical development and biomarker science) and a clinical study responsible scientist.  The span of studies in scope are phase 1 (including focused experimental medicine studies) through Proof of Concept.

The position reports into a Senior Director of the Translational Medicine (TM) group.  Within TM, the Director will be part of the Translational Medicine 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 pivotal  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:

• Design and execution of program translational strategies integrating both disease and pathway approaches.
• Design and execution of early clinical trials through PoC including experimental medicine studies. 
• Lead a cross-functional trial team to deliver on study milestones and commitments.
• Collaborate with translational science on the development and implementation of clinical biomarker and patient segmentation strategies.
• Support 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.