Medical Director, Autoantibody, Pipeline - US Medical Affairs

<div><h3>Job Summary</h3><p>We are searching for the best talent for Medical Director, Autoantibody Medical Affairs within our US Immunology Medical Affairs organization located in Horsham, PA. The role will contribute to the strategic planning and execution of Phase IIIb & IV trials, post‑marketing requirement studies, investigator‑initiated or collaborative studies, and serve as study responsible physician/scientist (SRP/SRS) for selected medical affairs trials. In addition, the Director will lead protocol development, medical and data monitoring, study operations, data analysis and reporting, and writing of study reports and publications. The role partners with real‑world evidence, health economics and outcomes research, biostatistics, and commercial marketing to execute the Autoantibody therapeutic area strategy with a focus on maternal‑fetal medicine and warm autoimmune hemolytic anemia.</p><h3>Key Responsibilities</h3><ul><li>Work with the Autoantibody Therapeutic Area Lead and other stakeholders to facilitate research and expand the knowledge of J&J products for autoimmune diseases.</li><li>Provide subject‑matter expertise and act as a US medical representative with marketing, sales, health economics, outcomes research, MSLs, and medical information.</li><li>Develop and execute medical‑affairs‑sponsored or supported Phase IIIb/IV trials, registries, real‑world evidence and collaborations by leading study design, protocol development, analysis plan development, and overall trial leadership, including execution, monitoring, supervision, compliance and risk mitigation.</li><li>Write and provide editorial comments for clinical study reports, abstracts and manuscripts related to J&J‑supported and sponsored studies.</li><li>Contribute to the preparation of regulatory submissions and interactions with Health Authorities (particularly the FDA) and ensure post‑marketing commitments are satisfied efficiently and scientifically.</li><li>Provide US medical input to R&D, including design of R&D clinical trials, presentations and publications.</li><li>Contribute to the Autoantibody Medical Affairs strategy, and potentially lead one or more Integrated Evidence Teams for approved and pipeline products/indications.</li><li>Develop and maintain an Integrated Evidence Generation Plan (IEGP) for approved and pipeline products/indications.</li><li>Support payer‑related materials and data needs for market‑access efforts.</li><li>Collaborate with external investigators and thought leaders, serving as a liaison between company and clinical investigators, and develop credible relationships with medical societies and patient advocacy organizations.</li><li>Review and evaluate investigator‑initiated study concepts, champion prioritized concepts, and monitor study progress and milestones.</li><li>Support or lead the development of medical education content for the field medical team and partner with communications and scientific exchange teams on content development, review and approval.</li></ul><h3>Qualifications</h3><ul><li>MD, DO, PhD or PharmD degree is required.</li><li>At least 8–10 years of healthcare‑related experience (academic clinical research, clinical practice and/or pharmaceutical industry) with at least 2 years of experience in clinical study, registry or real‑world evidence.</li><li>Prior commercial/medical launch experience is preferred; pharmaceutical industry experience is highly preferred. Medical Affairs experience is a strong asset.</li><li>Experience in clinical trial design (Phase IIIb & IV) and clinical data interpretation is required.</li><li>Prior experience in clinical research and exposure to industry‑partnered activities are strongly preferred.</li><li>Experience in scientific investigation into mechanisms of autoimmune/alloimmune disease preferred.</li><li>Excellent attention to detail and organizational skills.</li><li>Experience interacting with healthcare professionals and other thought leaders is a strong asset.</li><li>Evidence of strong scientific writing skills and analytical thinking is essential.</li><li>Ability to work in a matrix environment is essential for success.</li><li>Up to 25% travel (primarily domestic & limited international) is required.</li></ul><h3>Location & Schedule</h3><p>The position is located in Horsham, PA and follows a hybrid schedule of three days in the office and two days remotely per week.</p><h3>Equal Opportunity Employment</h3><p>Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under the Veterans' Employment and Training Service (VEVRAA) and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an inclusive interview process and to providing accommodations for applicants with disabilities.</p></div> #J-18808-Ljbffr