Associate Director, US Medical Affairs – Autoantibody Neuroimmunology

We are searching for the best talent for Johnson and Johnson is recruiting for an Associate Medical Director US Medical Affairs - Autoantibody Neuroimmunology located inHorsham PA.

About Immunology

Our expertise in Innovative Medicine is informed and inspired by patients and healthcare professionals 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 Director US Medical Affairs Autoantibody Neuroimmunology

About the Role

Johnson & Johnson is seeking an Associate Medical Director US Medical Affairs - Autoantibody Neuroimmunology to be a key member of the US Medical Affairs team where you will influence product development scientific communication and evidence generation efforts ensuring alignment with business objectives and regulatory standards.

This position resides in the Medical Affairs Autoantibody Neuroimmunology Therapeutic Area (TA) Team which is responsible for developing coordinating and executing the Therapeutic Area strategic plan for Medical Affairs. This therapeutic area strategic plan seeks to identify and address key stakeholders knowledge gaps through data dissemination data generation and education. The Medical Affairs Therapeutic Area (TA) teams are also responsible for designing and executing registries Phase IIIb/IV trials and any post-marketing requirements within the areas ofJanssen Immunologys current or emerging neuroimmunology assets in both adult and pediatric US indications. The Therapeutic Area (TA) team includes Medical Affairs Physicians Research Scientists Integrated Evidence Team (IET) Leaders and Medical Affairs Operations members.

The Associate Medical Director US Medical Affairs -Autoantibody Neuroimmunology will report to the Head Autoantibody Neuroimmunology US Medical Affairs- Immunology and be an important part of the Autoantibody Neuroimmunology TA team working closely with the other Medical Directors and Associate Directors as well as partners in Global Medical Affairs Real World Value and Evidence (RWV&E) Population Health Epidemiology R&D Biostatistics and US and Global Commercial Team members supportingImmunology and Autoantibody within the Johnson & Johnson organization.

The Associate Medical Director will be responsible for leading the development and execution of Medical Affairs sponsored and supported clinical programs for company products in the Neuroimmunology Therapeutic Area and will partner with other team members and cross-functional partners to formulate and execute scientific strategy on marketed products as well as address other medical questions and issues that arise from the field and experts in Neurology. The Associate Medical Director will also lead or contribute to development of related abstracts and manuscripts as either an author or reviewer.

Key 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 Affairswithin 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 /Requirements

• MD/DO degree (or international equivalent) is required. Current or prior Board Certification or Eligibility in Neurology or Neuromuscular Medicine is preferred.

• 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

• Strong organizational written and verbal communication skills including proficiency in effective and impactful oral presentations.

• Strong time management skills with the ability to be accountable for deliverables and timelines.

• 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.

• Energy and enthusiasm leadership skills and potential and the ability and desire to embrace building new expertise are essential.

Proficiency in English is necessary.

Preferred:

• Experience in neurology or neuromuscular medicine

• Experience with the planning and execution/writing of regulatory submissions protocols and/or scientific manuscripts.

• Experience with data analysis and review and/or clinical study execution as either an investigator or a medical monitor or clinical scientist.

• Experience with the clinical use or clinical study of immunologic biologics.

Other:

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

Join Us!

If you are a strategic thinker with a passion for neuroimmunology and a desire to impact patient lives globally this is your opportunity to make a difference.

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. If you are an individual with a disability and would like to request an accommodation external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.

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