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Director, Medical Affairs Gastroenterology TA

  • Título Director, Medical Affairs Gastroenterology TA
  • Função R&D
  • Sub função Medical Affairs
  • Local Horsham, Pennsylvania, United States; Cambridge, Massachusetts, United States; Raritan, New Jersey, United States
  • Postado
  • ID obrigatória 2306125566W
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Janssen Scientific Affairs, LLC., a member of Johnson & Johnson's Family of Companies, is recruiting for a Director of Immunology, Learning & Development to be based in Horsham, Pennsylvania.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Redefining lives by finding new and better ways to prevent, intercept, treat and cure disease encourages us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal.

Janssen Immunology Medical Affairs position of Director, Gastroenterology located in Horsham, PA

This position resides in the Gastroenterology Therapeutic Area Strategy (TAS) Team which is responsible for developing, coordinating and executing the Therapeutic Area strategic plan for Medical Affairs as well as executing supportive safety and efficacy studies, including those that are a result of US regulatory post-marketing commitments.   This therapeutic area strategic plan seeks to identifying and addressing key stakeholders’ knowledge gaps through data dissemination, data generation and education.  The position is primarily responsible for designing and executing registries, Phase IIIb/IV trials and other post-marketing requirements within current or emerging US GI indications.  

The Medical Affairs Therapeutic Area (TA) teams are responsible for developing, coordinating and executing the US gastroenterology TA strategic plan for Medical Affairs. This position is responsible for designing and executing registries, Phase IIIb/IV trials and any post-marketing requirements within the areas of JBI’s current or emerging gastroenterology assets in both adult and pediatric US indications.   The Therapeutic Area (TA) team includes Medical Affairs Physicians, Research Scientists, Integrated Evidence Team Leaders, and Operations members. The Associate Director, Gastroenterology position will be part of the gastroenterology TA   team and will work closely with Global Medical Affairs, Real World Value and Evidence (RWV&E), Population Health, Epidemiology,  and Commercial team members supporting Immunology and Gastroenterology within the Janssen organization.

The Director, Gastroenterology will be responsible for leading the development and execution of Medical Affairs sponsored and supported clinical programs for company products in the gastroenterology therapeutic area and will partner with other GI team members, as well as real-world evidence, RWV&E, R&D, biostatistics, and commercial marketing personnel through integrated evidence teams (and other touchpoints) 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 inflammatory bowel disease. The Director Gastroenterology will also lead or contribute to development of related abstracts and manuscripts.

Key Responsibilities:

  • Serves 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 Gastroenterology TA, in a largely independent manner. This will include study design, protocol development, regulatory communications, KOL and investigator interactions, support of execution, and supervision of clinical studies of all types: Phase IIIb/IV, registries, real world evidence, and investigator-initiated studies and collaborations supported by US Medical Affairs 
  • Helps to drive US GI MA strategy, working cross-functionally with partners within the GI Integrated evidence team (IET), including RWV&E, IETLs, SCG, Marketing brand teams, as well as potentially IBD Disease Area Stronghold (DAS), R&D, Global Medical Affairs and  Global Commercial partners to promote and execute the GI TA Strategy for establishing access as well as evidence generation and dissemination.
  • Oversees the preparation of regulatory submissions and interactions with Health Authorities (and particularly the FDA) and helps to ensure regulatory post-marketing commitments are efficiently satisfied with cost-effective, efficient, and scientifically rigorous methods.
  • Serves as the primary subject matter expert on previous and new data in support of US Immunology approved (or planned) GI 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 Gastroenterology 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).
  • Leads the development of abstracts and manuscripts related to Janssen supported and sponsored studies, with a focus on safety analyses and experience.
  • Builds and manages effective relationships with key opinion leaders and investigators related to Medical Affairs studies and strategic initiatives.

The anticipated base pay range for this position is $186,000 to $322,000.



  • MD degree (or international equivalent) is required. Board Certification or Eligibility in Gastroenterology is preferred.

Experience and Skills:


  • A minimum of 2+ years of pharmaceutical industry experience and/or 9 years post graduate medical practice that includes experience in clinical studies, registries, epidemiology Health Outcomes, Managed Care interactions, or regulatory experience is required.
  • Experience with the use and/or study of immunologic biologics is required.
  • Strong organizational skills, written and verbal communication skills are required.
  • Excellent time management skills with the ability to be accountable for deliverables and timelines is 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 is mandatory.
  • Energy and enthusiasm, Strong leadership skills, and the ability and desire to embrace building new expertise are essential.
  • Excellent oral and written communication and presentation skills are required


  • Experience in the gastroenterology therapeutic area, especially in inflammatory bowel disease, is preferred.
  • Experience with the planning and execution/writing of regulatory submissions is preferred.
  • Experience with data analysis and review and study medical monitoring is preferred.


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

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.]


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