Associate Director, US Medical Affairs - Autoantibody Neuroimmunology

Johnson & Johnson

Horsham, PA

JOB DETAILS
SKILLS
Adverse Events, Analysis Skills, Biotech and Pharmaceutical, Candidate Sourcing, Clinical Practices/Protocols, Clinical Research, Clinical Support, Clinical Trial, Consulting, Cross-Functional, Disease, Disease Immunity, Disease Prevention and Control, Diversity, Epidemiology, FDA (Food and Drug Administration), GCP (Good Clinical Practices), Healthcare, Immunology, Industry/Trade Analysis, Maintain Compliance, Marketing, Medical Affairs, Medical Products, Medicine, Mentoring, Neurology, Neuromuscular, Pediatrics, Phase IV Clinical Trials, Product Development, Product Programs, Publications, Quality Assurance, Quality Control, Regulations, Regulatory Submissions, Relationship Management, Research & Development (R&D), Scientific Research, Standard Operating Procedures (SOP), Strategic Planning, Team Lead/Manager
LOCATION
Horsham, PA
POSTED
30+ days ago

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.

Job Function: Medical Affairs GroupJob Sub Function: Medical Affairs - MDJob Category: Scientific/Technology

All Job Posting Locations: Horsham, Pennsylvania, United States of America

Job Description:

We are searching for the best talent for Johnson and Johnson is recruiting for an Associate Medical Director, US Medical Affairs - Autoantibody Neuroimmunology, located in Horsham, 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 https://www.jnj.com/innovative-medicine

Associate Director, US Medical Affairs - Autoantibody Neuroimmunology

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 of Janssen Immunology's current or emerging neuroimmunology assets in both adult and pediatric US indications.

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.
  • 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.

Preferred 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

About the Company

J

Johnson & Johnson

Caring for the world, one person at a time... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.

Our Family of Companies comprises: The world’s sixth-largest consumer health company.
The world’s most comprehensive medical devices business.
The world’s sixth-largest biologics company.
And the world’s fifth-largest pharmaceuticals company.

We have more than 265 operating companies in more than 60 countries employing approximately 126,500 people. Our worldwide headquarters is in New Brunswick, New Jersey, USA.

COMPANY SIZE
10,000 employees or more
INDUSTRY
Healthcare Services
FOUNDED
1887
WEBSITE
http://www.jnj.com/