Associate Director, US Medical Affairs – Autoantibody Neuroimmunology

Role Summary

The Associate Medical Director, US Medical Affairs - Autoantibody Neuroimmunology will be a key member of the US Medical Affairs team, influencing product development, scientific communication, and evidence generation, ensuring alignment with business objectives and regulatory standards. They will lead the development and execution of Medical Affairs sponsored and supported clinical programs in Neuroimmunology and collaborate with cross-functional partners to formulate scientific strategy and address medical questions, with opportunities to contribute to abstracts and manuscripts. This role is based in Horsham, Pennsylvania.

Responsibilities

• 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.
• 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.
• 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.
• Contributes as a subject matter expert on previous and new data in support of US Immunology approved (or planned) Neuroimmunology drugs and indications, partnering particularly with respective marketing brand teams (as well as other commercial and IET partners, including RWVE, SCG, V&E Field and Med Info and other CAC partners).
• Actively partners with individuals in Autoantibody Neuroimmunology TA and other groups inside and outside Medical Affairs (e.g. Biostats, GCO, Regulatory Affairs, QA and QC) to create Analysis Plans, safety data review for database locks and ensure compliance with study monitoring and other SOP/GCP requirements (and support audits, as needed).
• Contributes to or leads the development of abstracts and manuscripts related to J&J supported and sponsored studies, with a focus on efficacy, outcomes, and safety/adverse event analyses.
• Builds and manages effective relationships with key opinion leaders and investigators related to Medical Affairs studies and strategic initiatives.

Qualifications

• Required: MD/DO degree (or international equivalent).
• Preferred: Board Certification or Eligibility in Neurology or Neuromuscular Medicine.
• Required: At least 1.5 years of pharmaceutical industry experience and/or at least 5 years post-graduate clinical medical practice that includes experience in clinical neurology or neuromuscular medicine and/or experience with clinical studies, registries, epidemiology or health outcomes.
• Required: Strong organizational, written, and verbal communication skills, including proficiency in effective and impactful oral presentations.
• Required: Strong time management skills with the ability to be accountable for deliverables and timelines.
• Required: The ability to work in a matrix environment, collaborating effectively with many cross functional partners and succeed in participating in and leading cross functional teams.
• Required: Energy and enthusiasm, leadership skills and potential, and the ability and desire to embrace building new expertise are essential.
• Required: Proficiency in English is necessary.
• Preferred: Experience in neurology or neuromuscular medicine.
• Preferred: Experience with the planning and execution/writing of regulatory submissions, protocols, and/or scientific manuscripts.
• Preferred: Experience with data analysis and review, and/or clinical study execution as either an investigator or a medical monitor or clinical scientist.
• Preferred: Experience with the clinical use or clinical study of immunologic biologics.

Skills

• Analytical Reasoning
• Clinical Research and Regulations
• Clinical Trials Operations
• Communication
• Consulting
• Healthcare Trends
• Industry Analysis
• Medical Affairs
• Publications Management
• Scientific Research
• Strategic Thinking
• Team Management

Additional Requirements

• Approximately 10% to 20% annual travel is generally required (primarily domestic, occasionally international).