Medical Director, Autoantibody, Neuroimmunology- US Medical Affairs

Johnson & Johnson•Horsham, PA

2d•Hybrid

About The Position

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 jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. We are searching for the best talent for a Medical Director, Autoantibody, Neuroimmunology - US Medical Affairs located in Horsham, PA About Immunology Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Our Immunology team leads in the development of transformational medicines for immunological disorders and illnesses. You can influence where medicine is going by restoring health to millions of people living with immune diseases. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine As a part of US Medical Affairs Immunology, the Medical Director, Autoantibody, Neuroimmunology, will contribute to the strategic planning and execution of Phase IIIb & IV trials, post-marketing requirement studies, investigator initiating or collaborative studies, serving as a study responsible physician/scientist (SRP/SRS) for select medical affairs trials. The Medical Director, Autoantibody, Neuroimmunology will contribute/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, Autoantibody, Neuroimmunology 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 TA strategy across the asset, prioritizing key indications, with a focus on neuroimmunology.

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-word evidence, prior commercial/medical launch experience is required
Pharma industry experience is required; 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 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

Responsibilities

Work with the Autoantibody Therapeutic Area Lead, as well as other individuals within Medical Affairs and other functional areas within J&J, as necessary, to facilitate research and expanding the knowledge of J&J products for autoimmune diseases
Provide subject matter expertise and function as US medical representative with internal stakeholders across multiple functional areas including 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 (including execution, monitoring, supervision, compliance, and risk identification/ mitigation). This requires close partnership with a matrixed team inside and outside of Medical Affairs (e.g. Clinical Scientists, Program Management, Biostats, Post-Approval Delivery Unit, Regulatory Affairs, Quality, Medical Monitor, external investigators/Key Opinion Leaders).
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 input into design of R&D clinical trials, presentations and publications.
Contribute to US Autoantibody Medical Affairs strategy, and potentially leads one or more integrated evidence teams (IETs) for approved and pipeline Autoantibody products/indications, working cross-functionally with partners within the Autoantibody IET, including Medical Science Liaison (MSL) team leaders, Real World Value & Evidence, Strategic Customer Group, Marketing brand teams, as well as potentially Autoantibody Disease Area Stronghold, R&D, Global Medical Affairs, MSL and Global Commercial partners to promote and execute the Autoantibody TA Strategy for establishing access plans for and progress and outcomes for evidence generation activities and dissemination plans.
Contribute to and potentially lead (as the Integrated Evidence Team Leader) 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.
Support payer-related materials and data needs to scientifically support market access efforts.
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, & funding, and monitor study progress/milestones.
Support/ lead the development of medical education content for field medical team.
Partner with medical communications and scientific exchange teams on content development, review, and approval.