Associate Director, US Medical Affairs – Autoantibody Neuroimmunology

Johnson & Johnson Johnson & Johnson · Pharma · Horsham, PA +1

This role is for an Associate Medical Director in US Medical Affairs focusing on Autoantibody Neuroimmunology within Johnson & Johnson's Innovative Medicine division. The position involves developing and executing the Therapeutic Area strategic plan for Medical Affairs, which includes designing and managing registries, Phase IIIb/IV trials, and post-marketing requirements. The role requires influencing product development, scientific communication, and evidence generation, collaborating with various internal teams and external experts, and contributing to regulatory submissions and interactions. The Associate Medical Director will serve as the Study Responsible Physician for clinical programs, ensuring alignment with business objectives and regulatory standards.

What you'd actually do

  1. Serve as the Study Responsible Physician (SRP) for one or more studies, responsible for the development and execution of these Medical Affairs sponsored and supported clinical programs for company products in the Autoantibody Neuroimmunology TA, with mentorship and supervision. This will include study design, protocol development, regulatory communications, academic and community-based HCP and investigator interactions, support of execution, and supervision of clinical studies of all types, including: Phase IIIb/IV, registries, real world evidence, and investigator-initiated studies and collaborations supported by US Medical Affairs within the TA.
  2. Contributes to US Autoantibody Neuroimmunology Medical Affairs strategy, working cross-functionally with partners within the Integrated evidence team (IET), including RWV&E, IET Leads, SCG, Marketing brand teams, as well as potentially Disease Area Stronghold (DAS), R&D, Global Medical Affairs, Medical Science Liaison (MSL) and Global Commercial partners to promote and execute the TA Strategy for establishing access as well as evidence generation and dissemination.
  3. Contributes to the preparation of regulatory submissions and interactions with Health Authorities (and particularly the US FDA) and helps to ensure regulatory post-marketing commitments are efficiently satisfied with cost-effective, efficient, and scientifically rigorous methods.
  4. Contributes as a subject matter expert on previous and new data in support of US Immuno

Skills

Required

  • Medical Affairs
  • Neuroimmunology
  • Clinical trial design
  • Regulatory submissions
  • Data analysis
  • Scientific communication

Nice to have

  • Phase IIIb/IV trials
  • Registries
  • Real world evidence
  • Investigator-initiated studies