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Discovery & Pre-Clinical/Clinical Development

Sr. Director, Translational Medicine (GI)

  • Titolo Sr. Director, Translational Medicine (GI)
  • Funzione Discovery & Pre-Clinical/Clinical Development
  • Sottofunzione Clinical Development & Research & MD
  • Categoria Senior Director, Clinical Development & Research - MD (PL10)
  • Località Spring House, Pennsylvania, United States; La Jolla, California, United States; Cambridge, Massachusetts, United States
  • Data di pubblicazione
  • Riferimento 2406187790W
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Johnson and Johnson is recruiting for a Senior Director, Translational Medicine to be located in Spring House, PA, La Jolla, CA or Cambridge, MA.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.  

The Senior Director, Translational Medicine (TM), Gastroenterology (GI) 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 role requires expertise in Gastroenterology Early Phase Clinical Development. The TM Leader will become part of the GI DAS (Disease Area Stronghold) leadership team driving early phase strategy for the DAS.

The Senior Director of Immunology Translational Medicine (TM), GI may have responsibility as a manager of Translational Medicine Program Leads (TMPL) within TM. This responsibility inlcludes 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 the GI DAS core leadership team to contribute to development of the core DAS 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.

Qualifiche

·       MD or MD/PhD degree is required.

·       Minimum of 6-8 years of industry experience is required. 

·       Experience in early devleopment/translational medicine is required.

·       Training in Immunology is strongly preferred.

·       Subspecialty medical training and practice in Gastroenterology (adult or pediatrics) is 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 Spring House, PA, Cambridge, MA, or LaJolla, 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.

The anticipated base pay range for this position is $213,000 - $368,000.

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