Associate Medical Director US Medical Affairs -Gastroenterology

Johnson & Johnson•Horsham, PA

65d•Hybrid

About The Position

At Johnson & Johnson,â we believe health is everything. Our strength in healthcare innovation empowers us to build aâ world where complex diseases are prevented, treated, and cured,â where treatments are smarter and less invasive, andâ solutions are personal.â 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.â Learn more at https://www.jnj.com We are searching for the best talent for Associate Medical Director, US Medical Affairs -Gastroenterology based 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 Purpose: J&J Innovative Medicine is seeking an Associate Medical Director, US Medical Affairs -Gastroenterology to be a key member of the US Medical Affairs Immunology 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 Gastroenterology 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 J&J Innovative Medicine Immunology'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 (IET) Leaders, and Medical Affairs Operations members. The Associate Medical Director US Medical Affairs -Gastroenterology will report to the Head, Gastroenterology US Medical Affairs- Immunology, and be an important part of the Gastroenterology TA team, working closely with the other Gastroenterology 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 supporting Immunology and Gastroenterology within the Johnson & Johnson organization. The Associate Medical 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 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 inflammatory bowel disease. The Associate Medical Director, Gastroenterology will also lead or contribute to development of related abstracts and manuscripts as either an author or reviewer.

Requirements

MD/DO degree (or international equivalent) is required. Current or prior Board Certification or Eligibility in Gastroenterology or Immunology is preferred
Pharmaceutical industry interaction and/or experience and/or post-graduate clinical medical practice with experience in clinical immunology/gastroenterology and/or experience with clinical studies, registries, epidemiology or health outcomes required
Experience in gastroenterology, particularly in inflammatory bowel disease highly 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 and small molecules preferred
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

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 Gastroenterology TA, with mentorship and supervision. This will include study design, protocol development, regulatory communications, academic and community-based IBD 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 GI Medical Affairs strategy, working cross-functionally with partners within the GI Integrated evidence team (IET), including RWV&E, IET Leads, SCG, Marketing brand teams, as well as potentially IBD Disease Area Stronghold (DAS), R&D, Global Medical Affairs, Medical Science Liaison (MSL) and Global Commercial partners to promote and execute the GI 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) 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).
Contributes to or leads the development of abstracts and manuscripts related to J&J supported and sponsored studies, with a focus on IBD-related 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.

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