Associate Medical Director, Rheumatology Therapeutic Area

Johnson & Johnson Innovative Medicine•Horsham, PA

1d•Hybrid

About The Position

The Associate Medical Director, Rheumatology TA, US Medical Affairs will be an important part of the Rheumatology TA team, working closely with the other Rheumatology 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 Rheumatology 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 Rheumatology. They will work with other team members and cross-functional partners to formulate and execute scientific strategy for marketed and pipeline products. They will also address medical questions and educational gaps that arise from field insights and from Rheumatology HCPs. The Associate Medical Director will also lead or contribute to development of abstracts and manuscripts as either an author or reviewer. This position resides in the Rheumatology TA Medical Affairs team which is responsible for developing, coordinating and executing the TA strategic plan for Medical Affairs, which seeks to identify and address key stakeholders’ knowledge gaps through data generation, data dissemination and education. The TA Medical Affairs teams are also responsible for designing and executing Phase IIIb/IV trials and any post-marketing requirements within the areas of Immunology’s current or emerging assets in both adult and pediatric US indications.

Requirements

Advanced degree, such as PharmD, PhD, or MD/DO degree required; NP/PA will also be considered.
Rheumatology or Immunology therapeutic area expertise is highly preferred
At least 1.5 years of prior pharmaceutical industry experience strongly preferred and/or at least 5 years post-graduate clinical medical practice which may include research experience (clinical studies, registries, epidemiology or health outcomes)
Experience with clinical study, registry, or real-word evidence study and prior commercial/ medical launch experience are strongly preferred
Excellent interpersonal and public speaking skills, and experience interacting with health care professionals and other thought leaders is essential
Evidence of strong scientific writing skills and analytical thinking is essential
Strong leadership, teaming and collaboration skills are essential
Strong organizational, written, and verbal communication skills, including proficiency in effective and impactful oral presentations

Responsibilities

Contributes to US Rheumatology Medical Affairs strategy and will actively contribute to one or more integrated evidence teams (IETs) for approved and pipeline Rheumatology products/indications, working cross-functionally with partners within the IETs, including Medical Science Liaison (MSL) team leaders, RWV&E, Field V&E, SCG, Marketing brand teams, as well as potentially Rheumatology Disease Area Stronghold (DAS), R&D, Global Medical Affairs, (MSL) and Global Commercial partners to support execution of the TA Strategy for establishing access as well as plans for evidence generation and dissemination plans.
Contributes to and leads the cross-functional team to develop and maintain a current, strategically aligned and annually updated Integrated Evidence Generation Plan (IEGP) for approved and pipeline Rheumatology products/indications.
Supports payer-related materials and data needs to scientifically support market access efforts.
Contributes as a subject matter expert on analysis of key data in support of US Immunology for approved or planned therapies 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)
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.
May serve as Study Responsible Physician (SRP) or Study Responsible Scientist (SRS) (depending on terminal degrees) for one or more clinical studies of company products and be responsible for their development and execution 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 Affairs within the TA.
Actively partners with individuals in TA team 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 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.
Support the fulfillment of medical information requests from field medical and field commercial teams.
Support/lead the development of medical education content for field medical team.
Partner with medical communications and scientific exchange teams on content development, review, and approval.
Identify new key opinion leaders (KOLs) and develop strong KOL collaborations on clinical trial development and medical affairs activities.
Establish and foster relations with medical societies and patient advocacy organizations.