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R&D

Senior Director, Translational Medicine Program Lead-Immunology

  • Título Senior Director, Translational Medicine Program Lead-Immunology
  • Función R&D
  • Sub función Clinical Research MD
  • Ubicación Cambridge, Massachusetts, United States; North America; La Jolla, California, United States; Spring House, Pennsylvania, United States
  • Publicado
  • Identificación requerida (Req ID) 2206085469W
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Descripción

Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Senior 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 Senior 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 Senior Director, TM, will decisively contribute to accelerating the Immunology pipeline from portfolio entry to Proof-of-Concept (PoC). 

The Senior Director of Immunology Translational Science and Medicine (TSM), will have responsibility as a manager of Translational Medicine Program Leads (TMPL) within TM. This responsibility includes training and mentoring TMPLs (Associate Director and Director) who are accountable for developing early clinical development plans and executing clinical trials: from initial study design and continued monitoring and problem solving of trial execution to the analysis, interpretation, and communication of study results.  In this position the senior director will be accountable for providing an environment which encourages the company's commitment to equal employment opportunity and the value of a diverse work force, in ensuring that each report is supported in career and talent development goals.

This role will partner with TSM translational science and TM clinical science. In this leadership role they will be supported by other the senior leaders within the Translational Science and Medicine function, including the relevant disease area leaders (both in clinical development and translational science). Within TM, the Senior Director will be part of the leadership team with responsibility for creating and implementing organization initiatives. 

The position reports into a VP of Translational Medicine (TM).  TSM is a group within the Immunology Therapeutic Area, consisting of a Translational Medicine (TM) 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.

ESSENTIAL FUNCTIONS:

  • Represent TSM on core asset program teams requiring TM and clinical pharmacology advice & strategy. Represent TM at project functional stage gate reviews. Lead or participate in cross-functional working groups such as safety review boards or disease area working groups.
  • Work with the VPs of TSM, Immunology to refine the vision, mission, and strategic objectives of TM. Strengthen the culture of TM and be an ambassador in and outside the ITA.
  • Participate in Research and Early Development governance and budget management as a member of senior committees such as the Translational Leadership Team.
  • Partner with Clinical Science and Global Clinical Development Operations, to oversee all aspects of phase 0/1/2 study conduct of Immunology assets including, identification of clinical sites, investigators, and CROs that will participate in TSM trials.
  • Manage TSM staff responsible for the design, study set-up, execution and analysis/reporting of phase 0, and Ph2a studies according to Good Clinical Practice (GCP), International Conference of Harmony (ICH) guidelines and standard operating procedures. Review budgets of prospective clinical trials and ensure that trials are cost competitive. Support staff responsible for the design, set-up, execution, analysis and reporting of these studies.
  • Direct and supervise the preparation and review of protocols, clinical study reports, clinical pharmacology and translational medicine sections of early development plans, IBs, INDs, BLAs, SOPs, abstracts, manuscripts, and technical reports.
  • Introduce new technology and processes to improve probability of trial success
  • Participate in the development of TM operational templates; internal and cross-functional process improvement initiatives.
  • Responsible for presentation of results and updates of projects at department, project, corporate and scientific meetings.
  • Support business development and licensing evaluations.
  • Identify and collaborate with consultants, investigators, and key opinion leaders to optimize the preparation of early development strategies.

Calificaciones

  • MD or MD/PhD degree required.
  • Minimum of 6-8 years of industry and/or translational research experience required.
  • Training in Immunology strongly preferred.
  • Subspecialty medical training in Dermatology, Gastroenterology, or Rheumatology is preferred but not required.
  • Demonstrated supervisory and/or leadership experience with clinical and/or research teams is required.
  • Strong track record in publications is preferred.
  • Willingness and ability to travel, including trans-Atlantic travel (up to ~10%) is required.
  • Location is Cambridge, MA or La Jolla, CA.  

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.

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