The Senior Global Medical Affairs Leader (GMAL), Immunology 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. 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 which 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. The Senior GMAL, Gastroenterology will represent global medical affairs on the Gastroenterology Disease Area Stronghold team.
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.
The GMAL will be an active member of the CDT and will lead a global Medical Affairs TA 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
Responsible for the development and execution of the global publication plan 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.
Responsible to ensure all global activities follow J&J Compliance principles, eg. Health Care Compliance , etc.
A minimum of an MD degree is required, specialty training and certification in gastroenterology preferred.
Extensive clinical and/or pharmaceutical experience in Immunology or Gastroenterology is required. Experience in gastroenterology disease area and an established network with medical experts/opinion leaders in gastroenterology is highly preferred
A minimum of 10 years of combined relevant experience in a medical/clinical environment and/or scientific function in the pharmaceutical industry is required. At least five 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 leading highly matrixed, cross-functional work teams comprised of high-level managers and executives is required.
A demonstrated track record of success within Medical Affairs and/or clinical R&D.
Global mindset and direct experience in multiple markets, proven ability to partner cross culturally/regionally required.
In-depth knowledge of study methodology, study data reviews and analysis
Excellent knowledge of study execution, benefit risk management and regulatory affairs
Highly innovative with the ability to drive a complex and changing environment and effectively manage and resolve issues within the TA.
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)