Johnson & Johnson companies are equal opportunity employers.
Director, Translational Medicine - Immunology Development-2443131122
Description
Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a, Director, Translational Medicine – Immunology Development, located in Spring House, PA.
Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.
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, Immunology Development, will be a leader in the Immunology Translational Medicine (ITM) team, responsible for the clinical and scientific aspects of primarily Phase 0/ 1 Translational Medicine / Clinical Pharmacology studies with occasional Phase 2a responsibility. In this capacity, the Associate Director / Director, ITM, will significantly contribute to advance the Immunology Therapeutic Area pipeline of Janssen R&D (Pharmaceutical Companies of Johnson & Johnson) from pre-clinical stages to Proof-of-Mechanism (POM) and/or Proof-of-Concept (POC).
The position reports into the head of TM-Development group, one of two groups comprising the ITM department of the Immunology Therapeutic Area (ITA).The disease areas that are the focus of the ITA are rheumatologic, autoimmune, respiratory, allergic, dermatologic, and gastrointestinal diseases. The ITA portfolio comprises both large and small molecule drugs / NMEs.
Organizationally, ITM resides in the Clinical Development organization of the ITA. The TM-Science group has a experimental medicine and disease area focus, while TM-Development, has a stronger operational and compound focus. Together, TM-Science and TM-Development provide the necessary scientific and clinical expertise to advance a world-class pipeline of small molecules and biologic agents to address unmet need in immune-mediated diseases. This position will contribute experimental as well as clinical development expertise to ITM projects and will play an important role in the medical monitoring of ITM studies.
They will design and execution of compound-centric and disease-centric translational strategies. Design and execution of Phase 0-1 and occasionally Phase 2 Trials of Small and large molecules, alternative scaffolds, Early and late development (late development Phase 1 and experimental medicine), Clinical Pharmacology, FIH, POM in FIH or P1b, Clinical Pharm (PK/PD, DDI, special populations, etc.). Contribute to innovation through participation in disease strategy team and through experimental medicine studies and business Development, including due diligence activities.
Design Translational Plans and identify appropriate FIH, POM (and POC) study designs for NME early development programs, in collaboration with Discovery Research, Systems Pharmacology & Biomarkers, CMC, Toxicology, Biotech CoE and other functions. Design strategies for new indication assessments of development compounds. Be an ITM ambassador within and outside of the ITA. Presentation of clinical pharmacology strategy and trial design for assigned NMEs. Implement approved strategies for early development of NMEs including FIH/POM/(POC) studies and for new indication assessment of compounds in development. Phase 0/1 (2) study responsibilities include: Identification of clinical sites and CROs that will participate in TM trials. Review budgets of prospective clinical trials and ensure that trials are cost competitive. Management of staff responsible for the design, set-up, execution, analysis, and reporting of these studies (Director Level only).Review and interpretation of 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. Report the status of clinical trials to upper management. 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. Direct medical monitoring needs are expected to be 2-4 small studies at any given time. Ensure adherence to GCP and to all relevant internal and external guidances. Participate in the development of TM operational templates; internal and cross-functional process improvement initiatives.
Qualifications
MD or MD/PhD with previous basic and/or clinical research experience and 3 years industry experience or an MD, MD/PhD along with a Fellowship and Board Certification with strong scientific passion and clinical research experience is required. Medical Specialty training or experience relevant to Immunologic Diseases (e.g. Rheumatology, Respiratory, Clinical Immunology, Gastroenterology etc.) is required. Phase 0/1/2 and Clinical Pharmacology experience preferred. Record of peer reviewed publication and experience in scientific presentations is preferred. Fluency in written and spoken English is required. Working knowledge of the use of Microsoft suite of software products including Excel and Word is required. Willingness and ability to travel 10%, including travel abroad is required.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W: LI
Primary Location:North America-United States-Pennsylvania-Spring House
Organization: Janssen Research & Development, LLC. (6084)
Job Function: Clinical Research MD
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement
Director, Translational Medicine - Immunology Development-2443131122
Description
Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a, Director, Translational Medicine – Immunology Development, located in Spring House, PA.
Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.
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, Immunology Development, will be a leader in the Immunology Translational Medicine (ITM) team, responsible for the clinical and scientific aspects of primarily Phase 0/ 1 Translational Medicine / Clinical Pharmacology studies with occasional Phase 2a responsibility. In this capacity, the Associate Director / Director, ITM, will significantly contribute to advance the Immunology Therapeutic Area pipeline of Janssen R&D (Pharmaceutical Companies of Johnson & Johnson) from pre-clinical stages to Proof-of-Mechanism (POM) and/or Proof-of-Concept (POC).
The position reports into the head of TM-Development group, one of two groups comprising the ITM department of the Immunology Therapeutic Area (ITA).The disease areas that are the focus of the ITA are rheumatologic, autoimmune, respiratory, allergic, dermatologic, and gastrointestinal diseases. The ITA portfolio comprises both large and small molecule drugs / NMEs.
Organizationally, ITM resides in the Clinical Development organization of the ITA. The TM-Science group has a experimental medicine and disease area focus, while TM-Development, has a stronger operational and compound focus. Together, TM-Science and TM-Development provide the necessary scientific and clinical expertise to advance a world-class pipeline of small molecules and biologic agents to address unmet need in immune-mediated diseases. This position will contribute experimental as well as clinical development expertise to ITM projects and will play an important role in the medical monitoring of ITM studies.
They will design and execution of compound-centric and disease-centric translational strategies. Design and execution of Phase 0-1 and occasionally Phase 2 Trials of Small and large molecules, alternative scaffolds, Early and late development (late development Phase 1 and experimental medicine), Clinical Pharmacology, FIH, POM in FIH or P1b, Clinical Pharm (PK/PD, DDI, special populations, etc.). Contribute to innovation through participation in disease strategy team and through experimental medicine studies and business Development, including due diligence activities.
Design Translational Plans and identify appropriate FIH, POM (and POC) study designs for NME early development programs, in collaboration with Discovery Research, Systems Pharmacology & Biomarkers, CMC, Toxicology, Biotech CoE and other functions. Design strategies for new indication assessments of development compounds. Be an ITM ambassador within and outside of the ITA. Presentation of clinical pharmacology strategy and trial design for assigned NMEs. Implement approved strategies for early development of NMEs including FIH/POM/(POC) studies and for new indication assessment of compounds in development. Phase 0/1 (2) study responsibilities include: Identification of clinical sites and CROs that will participate in TM trials. Review budgets of prospective clinical trials and ensure that trials are cost competitive. Management of staff responsible for the design, set-up, execution, analysis, and reporting of these studies (Director Level only).Review and interpretation of 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. Report the status of clinical trials to upper management. 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. Direct medical monitoring needs are expected to be 2-4 small studies at any given time. Ensure adherence to GCP and to all relevant internal and external guidances. Participate in the development of TM operational templates; internal and cross-functional process improvement initiatives.
Qualifications
MD or MD/PhD with previous basic and/or clinical research experience and 3 years industry experience or an MD, MD/PhD along with a Fellowship and Board Certification with strong scientific passion and clinical research experience is required. Medical Specialty training or experience relevant to Immunologic Diseases (e.g. Rheumatology, Respiratory, Clinical Immunology, Gastroenterology etc.) is required. Phase 0/1/2 and Clinical Pharmacology experience preferred. Record of peer reviewed publication and experience in scientific presentations is preferred. Fluency in written and spoken English is required. Working knowledge of the use of Microsoft suite of software products including Excel and Word is required. Willingness and ability to travel 10%, including travel abroad is required.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W: LI
Primary Location:North America-United States-Pennsylvania-Spring House
Organization: Janssen Research & Development, LLC. (6084)
Job Function: Clinical Research MD
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement