Associate Medical Director, Gastroenterology TA - US Medical Affairs

Johnson & Johnson Innovative Medicine•Horsham, PA

1d•Hybrid

About The Position

Associate Medical Director, Gastroenterology Therapeutic Area - US Medical Affairs We are searching for outstanding talent to join the Gastroenterology TA team within the US Immunology Medical Affairs organization located in Horsham, PA as Medical Director, Gastroenterology, US Medical Affairs About J&J Innovative Medicine and the Immunology Therapeutic Areas Our expertise in Innovative Medicine is informed and inspired by patients, 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 About the Role The Associate Medical Director, US Medical Affairs - Gastroenterology will be a key member of the Medical Affairs Gastroenterology Therapeutic Area (TA) Team and will report to the Senior Director, Gastroenterology - TA Lead or a GI Medical Director within the broader US Medical Affairs- Immunology organization. They will work closely with the other Gastroenterology Medical Directors (and Associate Directors) as well as partners in US and 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 to create, shape, influence, and drive strategy for GI pipeline and approved products including evidence generation plans and subsequent execution, ensuring alignment with business objectives and regulatory standards. They will also lead and/or contribute to the development of related abstracts and manuscripts as either an author or reviewer. The Associate Medical Director, Gastroenterology will be responsible for contributing to the development and supporting the execution of Medical Affairs sponsored and supported clinical studies (Eg. Phase IIIb/IV trials, Post-Marketing Requirement studies, and investigator-initiated and collaborative studies) for approved and pipeline products in the Gastroenterology Therapeutic Area. Also, partnering with other GI team members in the US and Global Medical Affairs Organization, as well as Real World Value and Evidence (RWV&E), Epidemiology, R&D, biostatistics, commercial Marketing brand, and field-based (Eg MSL, commercial, and payer-facing value and evidence) teams, they will shape the clinical and economic value narrative for one or more GI products/indications by participating in and/or leading their Integrated Evidence Team (IET), accountable for a strong scientific strategy and its execution through evidence generation efforts and their subsequent impactful presentation and dissemination approaches. They will also partner with other GI team members and cross-functional partners to address medical/scientific questions that arise from the field and experts in inflammatory bowel disease and have an opportunity to lead or contribute to the development of important and impactful scientific abstracts and manuscripts as either an author or reviewer.

Requirements

An MD/DO degree (or international equivalent) is required, with current or prior Board Certification or Eligibility in Gastroenterology strongly preferred for this role.
At least 2 years of pharmaceutical industry experience and/or at least 5 years post-graduate clinical medical practice that includes experience in clinical gastroenterology and/or experience with clinical studies, registries, epidemiology or health outcomes is required.
Excellent analytical and strategic thinking aptitude, scientific writing proficiency, and strong organizational, written, and verbal communication skills, including proficiency in effective and impactful scientific oral presentations.
Strong organizational and time management skills with the ability to be accountable for deliverables and timelines is important.
Must have 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.
Approximately 10% to 20% annual travel is generally required (primarily domestic, occasionally international).
This position is located in Horsham, PA and follows a hybrid schedule of three days in the office and two days remotely per week.

Responsibilities

Serves as the Study Responsible Physician or scientist (SRP/SRS) 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.
Partners with individuals in Gastroenterology TA and other groups inside and outside Medical Affairs (e.g. Biostats, GCO, Regulatory Affairs, QA and QC) to develop the expertise to create Analysis Plans, perform safety data review for database locks and ensure compliance with study monitoring and other SOP/GCP requirements (and support audits, as needed).
Contributes to US GI Medical Affairs strategy and possibly leads one or more integrated evidence teams (IETs) for approved and pipeline GI products/indications, working cross-functionally with partners within the GI Integrated evidence team (IET), including Medical Science Liaison (MSL) team leaders, RWV&E, Field V&E, SCG, and Marketing brand teams, as well as potentially IBD Disease Area Stronghold (DAS), R&D, Global Medical Affairs, (MSL) and Global Commercial partners to execute the GI TA Strategy for establishing market access
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 to, and possibly leads, (as the IETL) the cross-functional team accountable for developing and maintaining a current, strategically aligned and annually updated Integrated Evidence Generation Plan (IEGP) for approved and pipeline GI products/indications. Also supports payer-related materials and data needs to scientifically support market access efforts.
Becomes a subject matter expert on previous and new data in support of US Immunology approved (or planned) GI drugs and indication (including IBD) learning to partner effectively with respective marketing brand teams (as well as other commercial and IET partners, including RWVE, SCG, V&E Field, Med Info, and other CAC partners).
Reviews and evaluates Investigator-Initiated Study (IIS) concepts, championing prioritized concepts through appropriate review, approval, & funding, and then monitors study progress/milestones.
Supports the fulfillment of medical information requests from field medical and field commercial teams and the development of medical education content, partnering with medical communications and scientific exchange teams on content development, review, and approval.
Contributes to 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.
Develops relationships with key opinion leaders and investigators related to Medical Affairs studies and strategic initiatives.