Cambridge, MA, USA | Johnson & Johnson
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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 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 Senior Director, Translational Medicine (TM), will lead a team of physician scientists responsible for creating and executing early development plans for the portfolio of assets in the Immunology TA, including the design and execution of Phase 0-1-2 clinical studies designed to advance the Immunology pipeline from pre-clinical stages to Proof-of-Concept(POC). The Senior Director will ensure an inclusive environment which encourages the company's commitment to equal employment opportunity and the value of a diverse work force. The Senior Director will be a program and experimental medicine leader in the Immunology Translational Science and Medicine (TSM). The Senior Director, TM, will be primarily responsible for creating and implementing program translational plans that are aligned with TA disease and pathway strategies.The successful candidate will be responsible for shaping the strategic vision for programs and executing early phase clinical studies.This role will partner with translational sciences to engage in external interactions with academic institutions having strong capabilities in translational studies and with external scientific experts.The Senior Director, TM, will also support Business Development activities including due diligence support. This work will include leading clinical and scientific aspects of translational studies from Phase 0 through Proof of Concept studies. In this role, the Senior Director, TM, will decisively contribute to accelerating the Immunology pipeline from portfolio entry to Proof-of-Concept (PoC).
The position reports into the Vice President of the Translational Medicine (TM) group.Within TM, the Senior Director will co-lead the Translational Medicine Program Lead (TMPL) 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 pivotalbridge 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:
•Will be responsible for the design of early phase programs and studies for New Molecular Entities (NMEs). Will develop the strategy for the early assessment of proof of mechanism/concept/relevance for New Molecular Entities undergoing development for new indications. This includes: Design and execution of program translational strategies integrating both disease and pathway approaches; collaboration with translational science on the development and implementation of clinical biomarker and patient segmentation strategies; and plans for executing formulation changes and integration of devices into later development.
• Participate in Research and Early Development governance and budget management as a member of senior committees such as the Translational Leadership Team.
• Work with the Head, Immunology Development and Head, Early Development (ED), to refine the vision, mission and strategic objectives of TM. Strengthen the culture of TM and be an ambassador in and outside the ITA.
• In partnership with Global Clinical Development Operations, oversee all aspects of phase 0/1/2 study conduct of Immunology assets including: Identification of clinical sites and CROs that will participate in TSM trials. Review budgets of prospective clinical trials and ensure that trials are cost competitive. Participate in the management of staff responsible for the design, set-up, execution, analysis and reporting of these studies.
• Responsible for the design of early and late phase clinical pharmacology programs for New Molecular Entities (NMEs), compounds in early development and devices.
• In partnership with ED and the DAS/PAS teams, develop and execute experimental medicine (Phase 0) studies. Introduce new technology and processes to the ITA to improve probability of success
• Review and interpret clinical trial data to enable timely internal decision-making and external communication with investigators and regulatory agencies. Oversee the preparation and assure the accuracy of the clinical study report.
• Manage TMPL team responsible for the design, study set-up, execution and analysis/reporting of phase 0 and phase 1 studies (i.e. proof of principal, bioequivalence etc.) according to Good Clinical Practice (GCP), International Conference of Harmony (ICH) guidelines and standard operating procedures.
• Study-related responsibilities include: Ensure adherence to GCP and to all relevant internal and external guidance. As a qualified physician, has ultimate responsibility for the medical management and safety aspects of the design, conduct and analysis of clinical trials for which he/she is responsible.
• Prepare and/or direct 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.
• Participate in the development of TM operational templates; internal and cross-functional process improvement initiatives.
• Represent TM on early development teams and on teams requiring TSM 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
• Responsible for presentation of results and updates of projects at department, project, corporate and scientific meetings.
• Support business development, including diligence activities and licensing evaluations.
• Identify and collaborate with consultants, investigators, and key opinion leaders to optimize the preparation of early development strategies.
•MD or MD/PhD degree is required.
•Minimum of 6 years of industry and/or translational research experience is required.
•Basic or Translational research background in Immunology is strongly preferred.
•Subspecialty medical training in adult or pediatric Dermatology, Gastroenterology, or Rheumatology is required.
•Successful track record of leading matrix teams and direct supervisory experience of 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.
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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