Medical Director, Autoantibody, Pipeline - US Medical Affairs (Horsham)

Job Title

Medical Director, Autoantibody Medical Affairs

Location

Horsham, Pennsylvania, United States of America

Job Description

We are searching for medical talent for the role of Medical Director, Autoantibody Medical Affairs within our US Immunology Medical Affairs organization located in Horsham, PA.

As a part of US Medical Affairs Immunology, the Medical Director, Autoantibody Medical Affairs will contribute to the strategic planning and execution of Phase IIIb & IV trials, post‑marketing requirement studies, investigator‑initiated or collaborative studies, serving as a study responsible physician/scientist (SRP/SRS) for select medical affairs trials. The Medical Director will contribute or lead the advancement of protocol development, medical/data monitoring, study operations, data analysis/reporting, writing of study reports and publications, as applicable. Additionally, the Medical Director will partner with colleagues on real‑world evidence, health economic and outcomes research, biostatistics, and work with commercial marketing colleagues through integrated evidence teams and other touchpoints to formulate and execute activities in support of the Autoantibody therapeutic area strategy across the asset, prioritizing key indications, with a focus on maternal fetal medicine and warm autoimmune hemolytic anemia.

Responsibilities

• Work with the Autoantibody Therapeutic Area Lead and other internal stakeholders across Medical Affairs and functional areas to facilitate research and expand knowledge of J&J products for autoimmune diseases.
• Provide subject matter expertise and function as a US medical representative with internal stakeholders across marketing and sales, health economics and outcomes research, MSLs, and medical information.
• Develop and execute Medical Affairs sponsored/supported Phase IIIb/IV trials, registries, real‑world evidence, and collaborations by leading study design, protocol development, analysis plan development and providing overall trial leadership.
• 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.
• Contribute to the preparation of regulatory submissions and interactions with Health Authorities (particularly the FDA) and help to ensure regulatory post‑marketing commitments are efficiently satisfied with cost‑effective, efficient, and scientifically rigorous methods.
• Provide US medical input to Research & Development (R&D), including design of R&D clinical trials, presentations and publications.
• Contribute to US Autoantibody Medical Affairs strategy and potentially lead one or more integrated evidence teams for approved and pipeline Autoantibody products/indications, working cross‑functionally with partners within the Autoantibody IET.
• Contribute to and potentially lead the cross‑functional team to develop and maintain a current, strategically aligned and annually updated Integrated Evidence Generation Plan (IEGP) for approved and pipeline products/indications.
• Collaborate with external investigators and thought leaders; serve as a liaison between company and clinical investigators and thought leaders, and develop credible relationships with thought leaders, medical directors, key regulatory officials, medical societies and patient advocacy organizations.
• Review and evaluate Investigator‑Initiated Study concepts, champion prioritized concepts through appropriate review, approval and funding, and monitor study progress/milestones.
• Support/lead the development of medical education content for field medical team and partner with medical communications and scientific exchange teams on content development, review, and approval.

Qualifications / Requirements

• MD, DO, PhD, or PharmD degree is required.
• At least 8–10 years total healthcare‑related experience (academic clinical research, clinical practice, and/or pharmaceutical industry) with at least 2 years of experience with clinical study, registry, or real‑world evidence; prior commercial/medical launch experience is preferred.
• Pharma industry experience is highly preferred; Medical Affairs experience is a strong asset.
• Experience in clinical trial design (Phase IIIb & IV) and clinical data interpretation is required.
• Prior experience in clinical research and exposure to industry‑partnered activities are strongly preferred.
• Experience in scientific investigation into mechanisms of autoimmune/alloimmune disease preferred.
• Excellent attention to detail and organization skills are vital for this position.
• Experience interacting with health care professionals and other thought leaders is a strong asset.
• Evidence of strong scientific writing skills and analytical thinking is essential.
• Ability to work in a matrix environment is essential for success in this role.
• Up to 25% travel (primarily domestic & limited international) is required.
• This position is located in Horsham, PA and follows a hybrid schedule of three days in the office and two days remotely per week.

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 VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs.