Johnson & Johnson companies are equal opportunity employers.
Lupus Clinical Lead-5283130822
Description
Janssen R&D, a member of Johnson & Johnson’s Family of companies, is recruiting for a Lupus Clinical Lead, for the Estrela venture within the Janssen Incubator, located in Spring House, PA.
Estrela is an entrepreneurial, scientifically-driven, Lupus-focused venture team within the newly established Janssen Incubator of Janssen R&D. We receive milestone-based funding and are leveraging external and Janssen R&D functional support to progress bio-therapeutic assets to clinical proof-of-mechanism in Lupus. We are committed to partnering with the external health care community, delivering superior biomedicines, and discovering patient-centric solutions for Lupus.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Lupus Clinical Lead will partner closely with Estrela scientists to drive the strategic design and execution of proof-of-mechanism Lupus clinical studies to deliver on our venture goal and advance the Janssen R&D Lupus portfolio. They will oversee Phase 0/1 study conduct including: strategic collaborations with Lupus key opinion leaders; identification of clinical sites and CROs that will participate in trials; review budgets and timelines to ensure that trials are competitive; partner with internal or external staff responsible for study execution, analysis and reporting; review and interpret clinical trial data to enable timely internal decision-making; external communication with investigators and regulatory agencies; and oversee the preparation and assure the accuracy of INDs and clinical study reports. The Lupus Clinical Lead will ensure adherence to GCP and to all relevant internal and external guidances. If MD or MD/PhD, this position will be responsible for medical monitoring and safety aspects of Lupus clinical trials. If PhD, this position will partner closely with assigned medical monitor to ensure safety aspects are fully compliant. The Lupus Clinical Lead will 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, abstracts, manuscripts, and technical reports, as needed. In addition, the Lupus Clinical Lead will be responsible for presentation of results and updates at internal meetings.
Qualifications
A Ph.D with post-doctoral experience and 12 years of business experience, or an M.D./Ph.D or M.D. with a minimum of 3 years industry experience is required. Previous Lupus clinical research experience is required and observational or interventional Lupus clinical trial experience is preferred. Other required competencies include: fluency in written and spoken English; working knowledge of the use of Microsoft suite of software products including Excel, Word, and Power Point; the ability to advise, persuade and negotiate with colleagues in a supportive and encouraging fashion; strong presentation and project management skills; being able to work in a cross-functional team environment; and willingness and ability to travel up to 10% of the time. Good organizational skills with the ability to multi-task and prioritize assignments and a record of peer reviewed publication and experience in scientific presentations is preferred.
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: R&D
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
Lupus Clinical Lead-5283130822
Description
Janssen R&D, a member of Johnson & Johnson’s Family of companies, is recruiting for a Lupus Clinical Lead, for the Estrela venture within the Janssen Incubator, located in Spring House, PA.
Estrela is an entrepreneurial, scientifically-driven, Lupus-focused venture team within the newly established Janssen Incubator of Janssen R&D. We receive milestone-based funding and are leveraging external and Janssen R&D functional support to progress bio-therapeutic assets to clinical proof-of-mechanism in Lupus. We are committed to partnering with the external health care community, delivering superior biomedicines, and discovering patient-centric solutions for Lupus.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Lupus Clinical Lead will partner closely with Estrela scientists to drive the strategic design and execution of proof-of-mechanism Lupus clinical studies to deliver on our venture goal and advance the Janssen R&D Lupus portfolio. They will oversee Phase 0/1 study conduct including: strategic collaborations with Lupus key opinion leaders; identification of clinical sites and CROs that will participate in trials; review budgets and timelines to ensure that trials are competitive; partner with internal or external staff responsible for study execution, analysis and reporting; review and interpret clinical trial data to enable timely internal decision-making; external communication with investigators and regulatory agencies; and oversee the preparation and assure the accuracy of INDs and clinical study reports. The Lupus Clinical Lead will ensure adherence to GCP and to all relevant internal and external guidances. If MD or MD/PhD, this position will be responsible for medical monitoring and safety aspects of Lupus clinical trials. If PhD, this position will partner closely with assigned medical monitor to ensure safety aspects are fully compliant. The Lupus Clinical Lead will 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, abstracts, manuscripts, and technical reports, as needed. In addition, the Lupus Clinical Lead will be responsible for presentation of results and updates at internal meetings.
Qualifications
A Ph.D with post-doctoral experience and 12 years of business experience, or an M.D./Ph.D or M.D. with a minimum of 3 years industry experience is required. Previous Lupus clinical research experience is required and observational or interventional Lupus clinical trial experience is preferred. Other required competencies include: fluency in written and spoken English; working knowledge of the use of Microsoft suite of software products including Excel, Word, and Power Point; the ability to advise, persuade and negotiate with colleagues in a supportive and encouraging fashion; strong presentation and project management skills; being able to work in a cross-functional team environment; and willingness and ability to travel up to 10% of the time. Good organizational skills with the ability to multi-task and prioritize assignments and a record of peer reviewed publication and experience in scientific presentations is preferred.
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: R&D
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