Johnson & Johnson Careers
Global Medical Affairs Leader, Director - Dermatology
Requisition ID: 9658181210
Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Global Medical Affairs Leader, Director - Dermatology to be located in Horsham, PA.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.janssenrnd.com/ for more information.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion.
Proud to be an equal opportunity employer.
The Global Medical Affairs Leader (GMAL), Director, Dermatology, under the direction of the Senior Director of Dermatology, is responsible for leading the clinical-commercial optimization of product development and life cycle management strategies and plans for the assigned marketed compounds and compounds in clinical development within the Immunology TA. He/she will lead the Global Medical Affairs Team and partner closely with Regional Medical TA/product leaders to develop integrated global medical affairs perspectives, strategies and plans for specified products/projects. The GMAL, will be a member of the Compound Development Teams, the Safety Management Teams and Global Commercial Teams, as well as an ad hoc member of the Clinical Team and Global Market Access Team, and will be responsible for development of the global medical affairs plan that reflects prioritized regional needs and are included in the overall Compound Development Plan. In addition, the GMAL will be accountable for the global publications plans, global opinion leader relations, global medical education (including symposia, speaker training) and global advisory boards for products starting in early development (phase IIA) and through launch of major life cycle management initiatives (earlier or later as needed). The GMAL will also be responsible for facilitating and ensuring a consistent approach to Medical Affairs programs/activities globally.
• Develop global medical affairs strategy and plan for the assigned compounds based on prioritized regional needs. Working with the CDT ensures integration with the overall global compound strategy, resulting in one global R&D and Medical Affairs compound development plan, inclusive of developing a Target Product Profile representing medical affairs global and regional value needs.
• Provide single Medical Affairs voice into the creation of compound development and LCM strategies, plans and trial design from phase IIa through phase IV.
• Responsible for pre-launch medical activities including product/Therapeutic Area global advisory boards, medical symposia and congress activities, coordination of regional activity in these areas.
• Be an active member of the CDT and lead a global Medical Affairs Team consisting of regionally designated Therapeutic Area Medical Affairs Leaders to create one medical affairs perspective and one “unified” voice on the CDT.
• Collaborate closely with the regional medical affairs representatives to develop integrated global medical affairs strategies and plans and maintain open, two-way communication to ensure regional medical affairs is up to date on all plans, progress and decisions.
• Synchronize input and output of the Med Affairs plan with the strategic and business plan calendars
• Maintain responsibility for the development and execution of global publication plans as well as review and approval of publications for marketed products and specified compounds in clinical development
• Manage the ReCAP process (review of all medical affairs sponsored clinical trials and Investigator Initiated Sponsored studies) for applicable products.
• Support development of the Company risk management strategy and plan as well as author and review specific sections of the Periodic benefit-risk assessment report for compounds. Perform Medical impact assessments as required.
• Maintain responsibility for ensuring that all global activities follow J&J Compliance principles (eg. Health Care Compliance etc.)
• A minimum of a Ph.D or MD degree (or equivalent) is required with specialty training and certification in dermatology preferred.
• Extensive clinical and/or pharmaceutical experience in Immunology is required. Experience in dermatology disease areas and having an established network with medical experts/opinion leaders in dermatology are highly preferred
• A minimum of 5 years of combined relevant experience in a medical/clinical environment and/or scientific function in the pharmaceutical industry is required; at least three years in the Medical Affairs environment is highly desireable.
• Knowledge of products, both J&J and competitors, in the Therapeutic Area
• A demonstrated track record of success within Medical Affairs and/or clinical R&D.
• In-depth knowledge of study methodology, study data reviews and analysis
• Excellent knowledge of study execution, benefit risk management and regulatory affairs
• Proven ability to act as a medical spokesperson for external audiences is required. Also required is strong experience developing and managing strategic relationships with medical experts/opinion leaders
• Proven track record on ethics and Credo principles
Janssen Global Services, LLC (6085)