MEDICAL DIRECTOR, RHEUMATOLOGY THERAPEUTIC AREA
2 weeks ago
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/.
As part of Immunology (IMM) Medical Affairs, the Medical Director, Rheumatology Therapeutic Area (TA) will lead strategic planning and cross-functional teams to design and execute Phase IIIb/IV trials & post-marketing requirements aligned to the J&J portfolio of IMM products. She/he will partner with colleagues from Commercial, R&D, Global Medical Affairs, Real-world Value & Evidence, Biostatistics, and work through integrated evidence teams and other touchpoints to formulate and execute medical & scientific strategy on both marketed products & pipeline assets. She/he will address medical questions and issues that arise from the field as a clinical subject matter expert (SME) in the Rheumatology therapeutic area. The Medical Director, Rheumatology TA will lead the advancement of both Collaborative & Investigator Initiated Studies and lead/contribute to development of related clinical study reports, abstracts and manuscripts.
* Responsible for working with the Senior Director, Strategic Lead, Rheumatology TA, as well as other individuals within IMM Medical Affairs and other functional areas within J&J to facilitate research expanding the knowledge of all J&J marketed products for immune-mediated disease.
* Collaborate with external thought leaders and investigators; serve as a clinical liaison between company and clinical investigators and thought leaders, and develop credible relationships with all external stakeholders and key regulatory officials.
* Provide subject matter expertise and function as US medical representative with internal stakeholders across multiple functional areas including marketing and sales, Real World Value & Evidence (RWV&E), MSLs, and medical information.
* Provide US Medical Affairs (MAF) input to R&D, including input into design of R&D clinical trials and presentations and publications.
* Help develop and execute MAF sponsored and supported clinical programs by taking the lead in study design, protocol development, execution, and supervision of Phase IIIb/IV trials, registries, real-world evidence, collaborative and investigator-initiated studies in the Rheumatology TA.
* Directly supervise and monitor trial conduct as well as work closely with other R&D and MAF medical monitor physicians to assure consistency of conduct across trials.
* Work closely with the Clinical Scientists, Program Management and MAF delivery unit (MADU) to manage trial operations and provide program leadership; be prepared to quickly identify trial conduct and logistical problems and provide solutions to rectify the issues.
* Write as well as provide editorial comments for phase IIIb/IV clinical study reports, abstracts and manuscripts related to J&J supported and sponsored studies.
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