Global Medical Affairs Leader (GMAL), Autoantibody/Rheumatology

Johnson & Johnson Innovative Medicine•Horsham, PA

3d•Hybrid

About The Position

The Global Medical Affairs Leader (GMAL) Autoantibody/Rheumatology is a director level individual contributor responsible for leading certain aspects of the clinical-commercial optimization for asset development and life cycle management strategies and plans for nipocalimab. The Global Medical Affairs Lead (GMAL) Autoantibody/Rheumatology is a member of the Immunology Global Medical Affairs team. The GMAL partners closely with Regional Medical TA/product leaders in building global medical affairs strategies and plans. The GMAL acts as a member of the Safety Management Team(s), Compound Development Team(s) and 3M team (medical/marketing/market access) and is responsible for establishing medical affairs plan that reflects prioritized global/regional needs, and which are included in the overall Asset Development Plan. The GMAL is responsible for global medical affairs strategy, global publication plans, global opinion leader engagement, global advisory boards and worldwide evidence generation plans.

Requirements

An advanced scientific/medical degree (e.g. MD, PhD, PharmD) is required
A minimum of 8 years of combined relevant experience in a medical/clinical environment and/or scientific function in the pharmaceutical industry is required
Medical Affairs experience is required
Ability to work in a matrix environment and understand global complexity is required
Global mindset and ability to partner cross culturally/regionally is required
A demonstrated track record leading highly matrixed, cross-functional work teams comprised of high-level managers and executives is required
Strong experience developing and managing strategic relationships with medical experts/opinion leaders is required
Highly innovative with the ability to drive a complex and changing environment and effectively manage and resolve issues is required
Experience developing and managing strategic relationships with medical experts/opinion leaders is required
Proven track record of ethical decision making is required
A minimum of 25% of domestic and international travel is required

Nice To Haves

Prior global medical affairs experience is highly preferred
Experience in rheumatology, immunology, rare disease is highly preferred
Launch experience is highly preferred
Having an established network with medical experts/opinion leaders in rheumatology, immunology and/or rare disease is preferred
In-depth knowledge of study/clinical methodology, study/clinical data reviews and analysis is preferred
Excellent knowledge of study execution, benefit risk management and life-cycle management are preferred

Responsibilities

Responsible to develop medical affairs strategy and plans for the compound (whether in development or marketed) based on prioritized regional needs for assigned regions in alignment with defined global medical objectives
Collaborate closely with the regional medical affairs and maintain open, two-way communication to ensure regional medical affairs is up to date on all plans, progress and decisions
Responsible for internal training strategy to assure continuous education of global and regional market access and medical affairs teams
Responsible for global publications planning process oversight (pre-launch and throughout lifecycle) including manuscripts, abstracts, posters and papers as well as pre-launch global KOL communications & speaker development
Review of manuscripts/presentation/posters to ensure alignment with strategy and effective communication/presentation in internal and external audiences
Responsible for ensuring all global activities follow J&J compliance principles, (eg. Health Care Compliance, etc.)
Responsible for pre- and post-launch medical activities, medical symposia and congress activities in coordination with the regions
Responsible for medical education strategy as well as creation and approval of medical material for external use (eg. HCP education)
Responsible for opinion leader relations product/Therapeutic Area global advisory boards
For new products, will review the Medical Information Core Responses
The GMAL may act as a member of product Safety Management Team(s) (SMT), Compound Development Team(s) (CDT) and Global Commercial Team(s) (GCT)
For marketed compounds, collaborate closely with global commercial and market access leaders
Responsible for providing medical input into market research and health outcomes research conducted by commercial and market access teams, respectively